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Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults

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: NCT03459703
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Courtney M Peterson, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE March 9, 2018
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE July 12, 2018
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • Fat loss and lean mass retention [ Time Frame: 14 weeks ]
    Percent of weight lost as fat, as measured by dual-energy X-ray absorptiometry (DXA). Lean mass retention will be quantified as 100% minus percent of weight lost as fat (i.e., is measured in the same units).
  • Weight loss [ Time Frame: 14 weeks ]
    Change in body weight (kg), as measured by scale weight
  • Absolute changes in body composition [ Time Frame: 14 weeks ]
    Changes in total fat mass, lean mass, bone mass, and regional values (kg), as measured by DXA. (This will be secondary to the assessment of fat loss and lean mass retention as specified above.)
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Fat loss and lean mass retention [ Time Frame: 14 weeks ]
    Percent of weight lost as fat, as measured by dual-energy X-ray absorptiometry (DXA). Lean mass retention will be quantified as 100% minus percent of weight lost as fat (i.e., is measured in the same units).
  • Weight loss [ Time Frame: 14 weeks ]
    Change in body weight (kg), as measured by scale weight
  • Absolute changes in body composition [ Time Frame: 14 weeks ]
    Changes in fat mass and lean mass (kg), as measured by DXA. (This will be secondary to the assessment of fat loss and lean mass retention as specified above.)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • Fasting glucose [ Time Frame: 14 weeks ]
    Fasting glucose (mg/dl)
  • Fasting insulin [ Time Frame: 14 weeks ]
    Fasting insulin (IU/L)
  • HbA1c [ Time Frame: 14 weeks ]
    HbA1c (%)
  • Lipids [ Time Frame: 14 weeks ]
    Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
  • Blood pressure [ Time Frame: 14 weeks ]
    Systolic and diastolic blood pressure (mm Hg)
  • Heart rate [ Time Frame: 14 weeks ]
    Heart rate in beats per minute
  • Waist circumference [ Time Frame: 14 weeks ]
    Waist circumference (cm)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Fasting glucose [ Time Frame: 14 weeks ]
    Fasting glucose (mg/dl)
  • Fasting insulin [ Time Frame: 14 weeks ]
    Fasting insulin (IU/L)
  • HbA1c [ Time Frame: 14 weeks ]
    HbA1c (%)
  • Lipids [ Time Frame: 14 weeks ]
    Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
  • Blood pressure [ Time Frame: 14 weeks ]
    Systolic and diastolic blood pressure (mm Hg)
  • Heart rate [ Time Frame: 14 weeks ]
    Heart rate in beats per minute
Current Other Pre-specified Outcome Measures
 (submitted: July 19, 2018)
  • Appetite [ Time Frame: 14 weeks ]
    Hunger and fullness as measured by Likert (1-5 scale) and visual analog scales (a 0-100 scale, with 0 meaning "Not at all" and 100 meaning "Extremely")
  • Food intake [ Time Frame: 14 weeks ]
    Energy intake and food intake in kcal/day, as measured using Remote Food Photography Method (RFPM)
  • Macronutrient intake [ Time Frame: 14 weeks ]
    % of calories as fat, carbohydrate, and protein, as measured using RFPM
  • Meal frequency [ Time Frame: 14 weeks ]
    Number of meals and snacks per day, as measured using RFPM
  • Meal times [ Time Frame: 14 weeks ]
    Clock times of meals and snacks, as measured using RFPM
  • Times of eating [ Time Frame: 14 weeks ]
    Start and stop times and mid-points of daily eating in clock time, as assessed by the daily adherence survey
  • Duration of daily eating [ Time Frame: 14 weeks ]
    Average duration of the daily eating period (hours), as measured by the daily adherence survey
  • Distribution of food intake across the daytime [ Time Frame: 14 weeks ]
    Distribution of calories eaten across the day in % per time period, as measured by a novel questionnaire that is being validated
  • Breakfast and nighttime eating habits [ Time Frame: 14 weeks ]
    Presence and degree of breakfast and nighttime eating, as measured by a novel questionnaire that is being validated
  • Adherence [ Time Frame: 14 weeks ]
    Self-reported adherence rate in days per week
  • Reasons for non-adherence [ Time Frame: 14 weeks ]
    Reasons for non-adherence, as measured by the daily adherence survey
  • Retention [ Time Frame: 14 weeks ]
    Attrition rate (%)
  • Depression [ Time Frame: 14 weeks ]
    Depression as measured by the Patient Health Questionnaire-9. (Each question is scored on a 0-3 scale, where 0 means "Not at all" and 3 means "Nearly every day." Answers to each question are tallied to create a single composite score of depression from 0-27, with higher values meaning more depressive symptoms.)
  • Mood states [ Time Frame: 14 weeks ]
    Mood states as measured by the Profile of Mood States (a 5-point scale with 1 meaning "Not at all" and 5 meaning "Extremely"). This study is particularly interested in the scores for anxiety and related moods.
  • Chronotype [ Time Frame: 14 weeks ]
    Chronotype/mid-point of sleep (in clock time), as measured by the Munich Chronotype Questionnaire
  • Stimulant usage [ Time Frame: 14 weeks ]
    Stimulant usage, as measured by the Munich Chronotype Questionnaire (in "servings" per time)
  • Sleep duration [ Time Frame: 14 weeks ]
    Sleep duration, as measured by the Pittsburgh Sleep Quality Index
  • Sleep quality [ Time Frame: 14 weeks ]
    Sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PQSI) (This study will use the Global PQSI score, which ranges from 0-21, where higher values correspond to worse sleep quality.)
  • Eating Behaviors [ Time Frame: 14 weeks ]
    Restrained, emotional, and external eating, as measured by the Dutch Eating Behavior Questionnaire. (Individual questions are scored on a 5-point scale ranging from "Never" to "Very often," and composite scores for restrained, emotional, and external eating are tabulated, with higher numbers reflecting more of each trait.)
  • Loneliness [ Time Frame: 14 weeks ]
    Loneliness, as measured by the UCLA Loneliness Scale (a 3-point scale with 1 meaning "hardly ever" and 3 meaning "often")
  • Intervention satisfaction [ Time Frame: 14 weeks ]
    Intervention satisfaction and barriers and facilitators of adherence, as measured by qualitative exit interview
  • Social life and daily habits [ Time Frame: 14 weeks ]
    Social life and daily habits, as measured by the frequency of occurrence of social activities (5- and 8-point rating scales)
  • Physical activity [ Time Frame: 14 weeks ]
    Physical activity status, as measured by the Baecke Physical Activity questionnaire
  • Plasma and salivary nitrate and nitrite [ Time Frame: 14 weeks ]
    Plasma and salivary nitrate and nitrite (nM)
  • Salivary nitrate reductase activity [ Time Frame: 14 weeks ]
    Salivary nitrate reductase activity (nmol / min / colony forming unit) in tongue swab samples
  • Salivary bacterial abundance [ Time Frame: 14 weeks ]
    Salivary bacterial abundance (colony forming units) in tongue swab samples
  • 24-hour urinary oxalate, citrate, sodium, calcium, chloride, potassium, and creatinine [ Time Frame: 14 weeks ]
    24-hour urinary oxalate, citrate, sodium, calcium, chloride, potassium, and creatinine, as measured in mg/day
  • 24-hour urinary phosphorus and uric acid [ Time Frame: 14 weeks ]
    24-hour urinary phosphorus and uric acid, as measured in g/day
  • 24-hour urinary aldosterone excretion [ Time Frame: 14 weeks ]
    24-hour urinary aldosterone excretion (µg/12 hr)
  • 12-hour urinary sodium and potassium [ Time Frame: 14 weeks ]
    12-hour urinary sodium and potassium (mmol/12 hr)
  • 12-hour urinary endothelin [ Time Frame: 14 weeks ]
    12-hour urinary endothelin (ng/12 hr)
  • 12-hour urinary nitric oxide [ Time Frame: 14 weeks ]
    12-hour urinary nitric oxide (mmol/12 hr)
  • 12-hour urinary albumin [ Time Frame: 14 weeks ]
    12-hour urinary albumin (mg/12 hr)
  • 12-hour urinary KIM-1 [ Time Frame: 14 weeks ]
    12-hour urinary KIM-1 (pg/g creatinine or pg/12 hr)
  • 12-hour urinary nephrin [ Time Frame: 14 weeks ]
    12-hour urinary nephrin (ng/g creatinine or ng/12 hr)
  • 12-hour albumin-to-creatinine ratio [ Time Frame: 14 weeks ]
    12-hour albumin-to-creatinine ratio
  • 12-hour urinary reactive oxidative stress [ Time Frame: 14 weeks ]
    12-hour urinary hydrogen peroxide and TBARs (µmol/g creatinine or µmol/12 hr)
  • Urinary exosomes [ Time Frame: 14 weeks ]
    Urinary exosomes (particles/ml)
Original Other Pre-specified Outcome Measures
 (submitted: March 2, 2018)
  • Appetite [ Time Frame: 14 weeks ]
    Hunger, desire to eat, capacity to eat, fullness, and stomach fullness, as measured by visual analog scales (a 0-100 mm scale, with 0 meaning "Not at all" and 100 meaning "Extremely")
  • Food intake [ Time Frame: 14 weeks ]
    Energy intake and food intake in kcal/day, as measured using food diaries and Remote Food Photography
  • Macronutrient intake [ Time Frame: 14 weeks ]
    % of calories as fat, carbohydrate, and protein (measured using the same methods as for outcome #11)
  • Meal frequency [ Time Frame: 14 weeks ]
    Number of meals and snacks per day (measured using the same methods as for outcome #11)
  • Meal times [ Time Frame: 14 weeks ]
    Clock times of meals and snacks (measured using the same methods as for outcome #11)
  • Times of eating [ Time Frame: 14 weeks ]
    Start and stop times and mid-points of daily eating in clock time, as assessed by the daily adherence survey
  • Duration of daily eating [ Time Frame: 14 weeks ]
    Average duration of the daily eating period (hours), as measured by the daily adherence survey
  • Adherence [ Time Frame: 14 weeks ]
    Self-reported adherence rate in days per week
  • Reasons for non-adherence [ Time Frame: 14 weeks ]
    Reasons for non-adherence, as measured by the daily adherence survey
  • Retention [ Time Frame: 14 weeks ]
    Attrition rate (%)
  • Depression [ Time Frame: 14 weeks ]
    Depression as measured by the Patient Health Questionnaire-9. (Each question is scored on a 0-3 scale, where 0 means "Not at all" and 3 means "Nearly every day." Answers to each question are tallied to create a single composite score of depression from 0-27, with higher values meaning more depressive symptoms.)
  • Mood states [ Time Frame: 14 weeks ]
    Mood states as measured by the Profile of Mood States (a 5-point scale with 1 meaning "Not at all" and 5 meaning "Extremely"). This study is particularly interested in the scores for anxiety and related moods.
  • Chronotype [ Time Frame: 14 weeks ]
    Chronotype/mid-point of sleep (in clock time), as measured by the Munich Chronotype Questionnaire
  • Stimulant usage [ Time Frame: 14 weeks ]
    Stimulant usage, as measured by the Munich Chronotype Questionnaire (in "servings" per time)
  • Sleep duration [ Time Frame: 14 weeks ]
    Sleep duration, as measured by the Pittsburgh Sleep Quality Index
  • Sleep quality [ Time Frame: 14 weeks ]
    Sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PQSI) (This study will use the Global PQSI score, which ranges from 0-21, where higher values correspond to worse sleep quality.)
  • Eating Behaviors [ Time Frame: 14 weeks ]
    Restrained, emotional, and external eating, as measured by the Dutch Eating Behavior Questionnaire. (Individual questions are scored on a 5-point scale ranging from "Never" to "Very often," and composite scores for restrained, emotional, and external eating are tabulated, with higher numbers reflecting more of each trait.)
  • Quality of social relationships [ Time Frame: 14 weeks ]
    Quality of social relationships, as measured by the Relationship Assessment Scale (a 5-point scale with 1 meaning "Low satisfaction" and 5 meaning "High satisfaction," with a composite score ranging from 7-35)
  • Loneliness [ Time Frame: 14 weeks ]
    Loneliness, as measured by the UCLA Loneliness Scale (a 4-point scale with 1 meaning "Never" and 4 meaning "Often," with a composite score ranging from 20-80)
  • Intervention satisfaction [ Time Frame: 14 weeks ]
    Intervention satisfaction and barriers and facilitators of adherence, as measured by qualitative exit interview
 
Descriptive Information
Brief Title  ICMJE Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults
Official Title  ICMJE Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults
Brief Summary

Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies in rodents report that TRF reduces body weight, improves blood sugar control, and reduces the risk of cardiovascular disease-even when food intake is matched to the control group or no weight loss occurs. Preliminary evidence suggests that TRF may also increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in humans. This study will test whether TRF enhances fat loss and increases weight loss in adults with obesity, relative to conventional dieting alone. In addition, this study will determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and will measure the feasibility and acceptability of TRF.

In conjunction with the parent study described above, four ancillary studies will be conducted:

  1. Effect of weight loss on nitrogen metabolism and bacteria in the mouth. The primary endpoints for this ancillary study are plasma and salivary nitrate and nitrite, and the secondary endpoints are salivary nitrate reductase activity and salivary bacterial abundance.
  2. Effect of weight loss on several biomarkers related to kidney stones. The primary endpoint for this ancillary study is urinary oxalate, and the secondary endpoints are urinary citrate, chloride, sodium, potassium, calcium, phosphorus, uric acid, and creatinine.
  3. Effect of meal timing on blood pressure regulation and kidney function. The primary endpoints of this ancillary study include urinary aldosterone excretion, sodium, potassium, and endothelin, whereas the secondary endpoints include nitric oxide and albumin. Additional exploratory endpoints include renal injury markers (KIM-1, nephrin, and urine albumin-to-creatinine ratio), measures of reactive oxidative stress (e.g., hydrogen peroxide and TBARs), and urinary exosomes. Urine will be analyzed in 12-hour bins to determine how meal timing affects differentially affects these endpoints during the daytime and nighttime. The effects of weight loss on these endpoints may also be considered.
  4. Validation of a meal timing questionnaire to assess the distribution of food intake throughout the day.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Statistical analyses will be performed blinded.
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Early Time-Restricted Feeding
    Eat all meals between 7 am - 3 pm for an average of ≥6 days per week.
    Other Names:
    • Early TRF
    • eTRF
  • Behavioral: Control Schedule
    Eat all meals over a 12-hour or longer period for an average of ≥6 days per week.
  • Behavioral: Structured Weight Loss Program
    A structured weight loss program with physical activity recommendations and dietary counseling.
Study Arms  ICMJE
  • Experimental: Early Time-Restricted Feeding
    Interventions:
    • Behavioral: Early Time-Restricted Feeding
    • Behavioral: Structured Weight Loss Program
  • Active Comparator: Control Schedule
    Interventions:
    • Behavioral: Control Schedule
    • Behavioral: Structured Weight Loss Program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2020)
90
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2018)
86
Actual Study Completion Date  ICMJE April 30, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are a new patient at the UAB Weight Loss Medicine Clinic
  • Aged 25-75 years old
  • BMI between 30-60 kg/m2 (inclusive)
  • Weigh less than 450 lbs
  • Wake up regularly between 4-9 am on most days.

Exclusion Criteria:

  • Diagnosed with diabetes, have an HbA1c of ≥6.5%, or are on diabetes medication
  • On weight loss medication
  • Addition of or withdrawal from a chronic medication within the past 10 weeks
  • Clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
  • Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
  • Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
  • Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
  • Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
  • Lost or gained more than 5 lbs of weight in the past month
  • Currently perform overnight shift work more than once per week on average
  • Regularly eat within a less than 10-hour period each day
  • Regularly eat dinner before 6 pm
  • Traveled more than two time zones away in the two months prior to enrolling in the trial
  • Will travel more than one time zone away during the study
  • Pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03459703
Other Study ID Numbers  ICMJE IRB-300001207
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Courtney M Peterson, University of Alabama at Birmingham
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alabama at Birmingham
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Courtney M Peterson, Ph.D. University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP