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Effect of Time-restricted Eating on Behaviour and Metabolism in Overweight Individuals at High Risk of Type 2 Diabetes (RESET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03854656
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : March 18, 2022
Sponsor:
Collaborators:
University of Copenhagen
Aalborg University Hospital
IMotions A/S
University of Leeds
Salk Institute for Biological Studies
Information provided by (Responsible Party):
Kristine Færch, Steno Diabetes Center Copenhagen

Brief Summary:
The aim of the present study is to investigate effects of 12 weeks time-restricted eating on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes.

Condition or disease Intervention/treatment Phase
Overweight and Obesity PreDiabetes Other: Time-restricted eating Not Applicable

Detailed Description:

Overweight and obese individuals with pre-diabetes or with a family history of diabetes or cardiovascular disease (CVD) are at high risk for developing type 2 diabetes (T2D) and CVD. Current prevention and treatment of obesity and T2D include energy restricted diets and increased levels of physical activity; however, adequate adherence to such strategies is difficult, and maintenance is challenging for most individuals, which stresses the need for feasible and sustainable interventions.

Circadian rhythms of behaviour and metabolism are closely related to the daily light/dark cycle and sleep-wake patterns and timing of food intake and fasting periods may affect the circadian rhythms of metabolic organs. In an evolutionary perspective, the pattern of food consumption has been characterised by periods of caloric intake when food was available and subsequent periods of fasting 9. This cyclic pattern leads to cycles of absorption and storage of energy and utilisation of the energy for e.g. tissue repair, stress resistance and vitality where expression of metabolic regulators coordinates with cellular processes, leading to efficient metabolism 10. Factors including the 24-hour availability of energy-dense foods, busy time schedules, different eating and sleep patterns during weekdays and weekends (i.e. 'social jetlag') challenge the feeding-fasting paradigm. Recent data suggest that an erratic diurnal eating pattern characterised by food intake largely spread throughout hours awake (≥15 h) and a concomitant short fasting period is highly prevalent in humans and animal suggest that circadian misalignment of food intake is associated with adverse metabolic effects. A number of animal studies and a few small studies in humans have reported promising effects of time-restricted eating (TRE), without concomitant dietary restrictions, on body weight and other cardiometabolic risk factors. There is a lack of randomized controlled trials investigating effect of TRE in individuals at high risk of type 2 diabetes and cardiovascular diseases.

The aim of the present study is to investigate effects of 12 weeks TRE on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes. Maintenance will be assessed at a follow-up visit 13 weeks after completion of the trial (26 weeks). Testing will be conducted at baseline and after 6, 12, and 26 weeks. Participants are instructed to follow randomization during one week assessment periods after testing at 6 and 12 weeks. Therefore, the total duration of the intervention is 13 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Time-restricted Eating on Behaviour and Metabolism in Overweight Individuals at High Risk of Type 2 Diabetes - the RESET Study
Actual Study Start Date : February 25, 2019
Actual Primary Completion Date : March 2, 2022
Actual Study Completion Date : March 2, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Control group for 13 weeks (n=50). Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.
Experimental: Time-restricted eating
Time-restricted eating for 13 weeks (n=50). In addition to the intervention, participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.
Other: Time-restricted eating

Participants will be instructed to eat within a self-selected 10-hour timeframe between 6AM and 8PM every day. All food/beverages except water must be consumed within the time-interval. Staff will help participants select a time-interval that fits into their daily life and optimally fulfil the following guiding principles:

  1. The first food item/beverage of the day should optimally be ingested at least 2 hours after usual wake-up time
  2. The last food item/beverage of the day should optimally be ingested at least 3 hours before usual bed time

Diet is ad libitum and with no further dietary restrictions. Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.





Primary Outcome Measures :
  1. Change in body weight (kg) [ Time Frame: Change from baseline to the end of the intervention (after 12 weeks) ]
    Measured in fasted state on a digital scale


Secondary Outcome Measures :
  1. Body weight (kg) [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured on a digital scale

  2. Body mass index (kg/m^2) [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Calculated from body weight (kg) and height (m)

  3. Fat mass (kg) [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured by Dual-energy X-ray Absorptiometry

  4. Fat free mass (kg) [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured by Dual-energy X-ray Absorptiometry

  5. Fat percentage (%) [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured by Dual-energy X-ray Absorptiometry

  6. Waist circumference (cm) [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured using tape measure

  7. Hip circumference (cm) [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured using tape measure

  8. HbA1c (mmol/mol and %) [ Time Frame: Changes from baseline. All four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from blood samples at all visits

  9. Systolic blood pressure (mmHg) [ Time Frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured under resting and fasting conditions

  10. Diastolic blood pressure (mmHg) [ Time Frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured under resting and fasting conditions

  11. Heart rate (bpm) [ Time Frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Measured under resting and fasting conditions during measurements of blood pressure and in the supine position by a handheld ECG measuring device (Vagus™)

  12. Resting energy expenditure (kcal/day) [ Time Frame: Changes from baseline. Measured at visits at baseline and after 12 weeks ]
    Measured by indirect calorimetry under resting and fasting conditions

  13. Substrate oxidation (respiratory exchange ratio) [ Time Frame: Changes from baseline. Measured at visits at baseline and after 12 weeks ]
    Measured by indirect calorimetry under resting and fasting conditions

  14. Metabolites [ Time Frame: Changes from baseline. Measured in the blood in the fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test (4 hours) at baseline and end of the intervention (after 12 weeks) ]
    Fasting and postprandial (after a standard mixed breakfast meal) concentrations of metabolites including but not limited to: glucose, lipids, cholesterol, free-fatty acids, and amino acids

  15. Hormones [ Time Frame: Changes from baseline. Measured in the blood in the fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test (4 hours) at baseline and end of the intervention (after 12 weeks) ]
    Fasting and postprandial (after a standard mixed breakfast meal) concentrations of hormones related to regulation of appetite, glucose and lipid metabolism (including but not limited to: insulin, glucagon, ghrelin, glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and peptide YY (PYY), leptin, fibroblast growth factor 19 (FGF-19), fibroblast growth factor 21 (FGF-21), growth differentiation factor 15 (GDF-15)).

  16. Circulating proteins that associate with low-grade inflammation and lipid metabolism [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Fasting levels of circulating proteins that associate with low-grade inflammation and lipid metabolism. Such proteins are captured by mass-spectrometry driven analyses of the plasma proteome i.e. proteins circulating in the blood

  17. Respiratory and glycolytic capacities of isolated peripheral blood mononuclear cells (PBMCs) [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Measured using the Seahorse method, which measures mitochondrial respiration

  18. Heart rate response to standing up from the supine position [ Time Frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks) ]
    Measured by a handheld ECG measuring device (Vagus™).

  19. Heart rate response to inhalation and exhalation [ Time Frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks) ]
    Measured by a handheld ECG measuring device (Vagus™).

  20. Heart rate response to forced exhalation during rest (valsalva maneuver) [ Time Frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks) ]
    Measured by a handheld ECG measuring device (Vagus™).

  21. Gastric emptying time (hours and minutes) [ Time Frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks). ]
    Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal

  22. Small bowel transit time (hours and minutes) [ Time Frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks). ]
    Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal

  23. Large bowel transit time (hours and minutes) [ Time Frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks). ]
    Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal

  24. Total gastrointestinal transit time (hours and minutes) [ Time Frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks). ]
    Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal

  25. Motility index [ Time Frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks). ]
    Calculated based on amplitudes and number of contractions measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal

  26. Attention measured using eye tracking [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Eye tracking metrics including gaze duration bias, gaze direction bias, fixations, saccades, pupil size/dilation, distance to screen, ocular vergence and blinks to measure attention in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire

  27. Emotions measured using facial expression analyses [ Time Frame: Changes from baseline. Fasted state at all four visits (baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Facial expression analyses using computer-vision algorithms (AFFDEX) to measure emotions in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire

  28. Arousal measured using galvanic skin response [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Changes in conductivity of the skin (galvanic skin response) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire

  29. Food choice [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times

  30. Implicit wanting [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time.

  31. Explicit liking [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale)

  32. Explicit wanting [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).

  33. Insulin sensitivity (indices) [ Time Frame: At all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Including but not limited to the Matsuda index

  34. Insulin resistance (indices) [ Time Frame: At all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Including but not limited to Homeostaic Model Assessment for Insulin Resistance (HOMA-IR)

  35. Subjective appetite [ Time Frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks) ]
    Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, and sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have nerver been this hungry before".

  36. Mean amplitude of glycaemic excursions (MAGE) [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Measured using continous glucose monitoring

  37. Continuous overall net glycaemic action (CONGA) [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Measured using continous glucose monitoring

  38. Daily time spent above different glucose concentrations (e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L) [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Measured using continous glucose monitoring.

  39. Mean glucose concentrations [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Measured using continous glucose monitoring.

  40. Standard deviation of glucose concentrations [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Measured using continous glucose monitoring.

  41. Variation coefficients of glucose concentrations [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Measured using continous glucose monitoring.

  42. Physical activity (time spent at different intensities) [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Sedentary time, light, moderate and vigorous intensity physical activity. Assessed from 24 h/day accelerometry

  43. Physical activity (counts/min) [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from 24 h/day accelerometry

  44. Physical activity energy expenditure (kcal/day) [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from 24 h/day accelerometry

  45. Physical activity (MET hours) [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from 24 h/day accelerometry

  46. Timing of physical activity (hh:mm) [ Time Frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from activity logs and 24 h/day accelerometry

  47. Energy intake (kcal/day) [ Time Frame: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from diet records

  48. Macronutrient intake (energy percentage) [ Time Frame: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from diet records

  49. Timing of dietary intake (hh:mm) [ Time Frame: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from diet records

  50. Sleep timing (hh:mm) [ Time Frame: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks ]
    Including bedtime, sleep onset, wake-up, time out of bed, sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry

  51. Sleep duration (min) [ Time Frame: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from sleep logs and 24 h/day accelerometry

  52. Sleep variability (min) [ Time Frame: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks ]
    Variability in bedtime, wake-up, sleep duration and sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry

  53. Sleep onset latency (min) [ Time Frame: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from sleep logs and 24 h/day accelerometry

  54. Sleep efficiency (%) [ Time Frame: Changes from baseline. Measured for 7 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from 24 h/day accelerometry

  55. Wakefulness (min) [ Time Frame: Changes from baseline. Measured for 7 days after the test days at baseline and after 6 and 12 weeks ]
    Assessed from 24 h/day accelerometry

  56. Self-reported gastrointestinal symptoms (part 1) [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from the questionnaires the Gastrointestinal Symptom Rating Scale (GSRS). Rated on 7-point likert scales. Range: 1 = absence of symptoms to 7 = very severe symptoms.

  57. Self-reported gastrointestinal symptoms (part 2) [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from the Gastrointestinal Symptom Score (PAGI-SYM). Rated on 6-point likert scales. Range: 1 = absence of symptoms to 6 = very severe symptoms.

  58. Self-reported gastrointestinal symptoms (part 3) [ Time Frame: Changes from baseline. Registered 7 days after the test days at baseline and after 12 weeks ]
    Number of symptoms. Assessed from logs.

  59. Self-reported autonomic symptoms [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from the questionnaire COMPASS31

  60. Self-reported control over eating [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from the questionnaire Control over Eating Questionnaire

  61. Self-reported sleepiness [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from the questionnaire the Epworth Sleepiness Scale

  62. Self-reported sleep quality [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from the questionnaire Pittsburgh Sleep Quality Index

  63. Self-reported chronotype [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from the Munich Chronotype Questionnaire

  64. Self-reported physical activity [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from questionnaire International Physical Activity Questionnaire

  65. Self-reported overall health and wellbeing [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from the questionnaire Self-reported health (SF-36 health survey)

  66. Self-reported eating behavior [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from The Dutch Eating Behavior Questionnaire

  67. Self-reported night eating [ Time Frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks) ]
    Assessed from The Night Eating Questionnaire

  68. Daily eating/drinking window (hh:min) [ Time Frame: Registrered every day (13 weeks intervention and 13 weeks follow-up period) ]
    Time of first and last meal/beverage

  69. Microbiome content and diversity [ Time Frame: Changes from baseline. Collected before or during test days at visits at baseline and after 12 weeks ]
    Determined from stool samples. Bacterial DNA and RNA will be purified from the stool samples and changes in the microbiome composition and function will be estimated based on sequencing of the microbiomes' DNA and RNA. Includes but is not limited to the Firmicute/Bacteroidete ratio.

  70. Motivation for participation (qualitative methods) [ Time Frame: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point. ]
    Themes and aspects related to motivation for participation will be assessed based on interviews with the participants including completers and potential drop-outs.

  71. Feasibility of the intervention (qualitative methods) [ Time Frame: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point. ]
    Themes and aspects related to feasibility of the intervention will be assessed based on interviews with the participants including completers and potential drop-outs.

  72. Satisfaction with the intervention (qualitative methods) [ Time Frame: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point. ]
    Themes and aspects related to satisfaction with the intervention will be assessed based on interviews with the participants including completers and potential drop-outs.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥30 kg/m2 or BMI ≥25 kg/m2 in combination with pre-diabetes (HbA1c ≥39-<48 mmol/mol)
  • Habitual eating/drinking window ≥12 hours (including foods/snacks and energy containing beverages e.g. soft drinks (except of water)) and an eating/drinking window of ≥14 hours minimum one day per week

Exclusion criteria

  • Daily smoking
  • For women: pregnancy, planned pregnancy (within the study period) or lactating
  • Frequent travels over time zones (max one return trip/travel over times zones (˃one hour time difference) during the 13 weeks intervention).
  • Shift work or partner engaged in shift work (if it affects the person's sleep and eating pattern)
  • Unable to understand the informed consent and the study procedures
  • Self-reported history of an eating disorder during the past three years
  • Self-reported weight change (>5 kg) within three months prior to inclusion
  • Diabetes
  • HbA1c ≥48 mmol/mol
  • Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression
  • Current treatment with medication or medical devices which significantly affect glucose metabolism, appetite, or energy balance
  • Current treatment with antidepressants
  • Bariatric surgery
  • Implanted or portable electro-mechanical medical device such as a cardiac pacemaker, defibrillator or infusion pump
  • Celiac disease, Crohn's disease, ulcerative colitis or proctitis
  • Alcohol/drug abuse or in treatment with disulfiram at time of inclusion
  • Concomitant participation in other intervention studies
  • Not able to eat ≥85% of the test meal because of e.g. allergy

Specific exclusion criteria for participants receiving SmartPillTM (n=60)

  • Gastrointestinal symptoms or diseases such as regular (weekly) abdominal pain, dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions or diverticulitis
  • Current treatment with medication or medical devices which significantly affect gastrointestinal motility or transit time (prokinetics, antidiarrheals, laxatives, or opioids)
  • Gastrointestinal surgery within 3 months before inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854656


Locations
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Denmark
Steno Diabetes Center Copenhagen
Gentofte, Denmark, DK-2810
Sponsors and Collaborators
Kristine Færch
University of Copenhagen
Aalborg University Hospital
IMotions A/S
University of Leeds
Salk Institute for Biological Studies
Investigators
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Principal Investigator: Kristine Færch, PhD Steno Diabetes Center Copenhagen
  Study Documents (Full-Text)

Documents provided by Kristine Færch, Steno Diabetes Center Copenhagen:
Statistical Analysis Plan  [PDF] February 28, 2022

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristine Færch, Senior Researcher and Team Leader, PhD, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT03854656    
Other Study ID Numbers: NNF17OC0027822
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristine Færch, Steno Diabetes Center Copenhagen:
Overweight
Obesity
Time-restricted eating
Prediabetes
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Overweight
Body Weight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia