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Impacts of Intermittent Fasting on Energy Balance and Associated Health Outcomes

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ClinicalTrials.gov Identifier: NCT02498002
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Iain Templeman, University of Bath

Brief Summary:

Obesity is a global concern with links to conditions such as diabetes. Historically, these conditions have been managed by reducing energy intake on a daily basis, which is often hampered by low adherence rates and compensatory reductions in physical activity. Intermittent fasting (IMF) has become popular as an alternative method of weight loss, where periods of normal eating are punctuated by days of fasting. However, despite its popularity, IMF is scarcely examined within the literature.

This study will examine the impact of IMF on energy balance and the associated health outcomes relating to conditions such as diabetes. To achieve this, 36 lean adults and 36 overweight/obese adults will be recruited, excluding those with conditions which may be adversely affected by fasting. Once enrolled, participants will complete a one month control phase, incorporating 12 days of diet and activity monitoring, to ensure their weight is stable before moving in to the intervention phase.

The intervention phase will begin with a lab protocol designed to examine body composition, resting metabolic rate and metabolic responses to two successive meals. Once completed, participants will be randomised to one of three diets which are listed below. Comparing the changes seen with diets 1 and 2 will provide the first direct comparison of IMF against more conventional strategies, while diet 3 will allow us to ascertain the role of weight loss in mediating any effects of IMF.

  1. Daily calorie restriction - Reduce energy intake by 25% on a daily basis
  2. IMF with weight loss - Alternate between 24 hour cycles of fasting and feeding with 150% of normal intake when feeding
  3. IMF without weight loss - Alternate between 24 hour cycles of fasting and feeding with 200% of normal intake when feeding

All three diets will last for 20 consecutive days, with transitions between each 24 hour diet cycle occurring at 15:00 each day to allow at least one main meal per day. When fasting, participants will only be permitted water and black tea/coffee to eliminate energy intake. Once again physical activity and diet will be monitored for 12 days during the intervention to examine changes in energy expenditure and ensure compliance.

Having completed all 20 diet cycles participants will return to the laboratory to repeat the protocol described earlier. Comparing these results against the values seen before the intervention will then allow the effects of IMF to be identified and compared.


Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Device: Physical Activity Monitoring (Actiheart) Other: Energy Intake Monitoring Other: Body Weight Monitoring Procedure: Intravenous Cannulation Procedure: Adipose Tissue Biopsy Drug: Lidocaine Hydrochloride Other: Post-Prandial Meal Tests Radiation: DEXA Scan Other: Actiheart Calibration Other: Daily Calorie Restriction Other: Intermittent Fasting with Weight Loss Other: Intermittent Fasting without Weight Loss Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impacts of Intermittent Fasting in Adults on Energy Balance, Body Composition, Postprandial Hormone Profiles and Gene Expression in Adipose Tissue
Actual Study Start Date : May 2015
Actual Primary Completion Date : September 4, 2018
Actual Study Completion Date : September 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Daily Calorie Restriction (DCR)
During the intervention phase, participants randomised to this treatment condition will be asked to reduce their normal energy intake by 25% on a daily basis.
Device: Physical Activity Monitoring (Actiheart)
Monitor physical activity using an Actiheart monitor during the required periods.

Other: Energy Intake Monitoring
Monitor energy intake by weighing and recording all foods/drinks consumed during the required periods.

Other: Body Weight Monitoring
Monitor body weight during monitoring phase to ensure stability despite other monitoring activities.

Procedure: Intravenous Cannulation
Fitting of an intravenous cannula to a vein on the forearm for blood sampling during laboratory protocols.

Procedure: Adipose Tissue Biopsy
This is an optional feature which if included involves the removal of a 0.5 gram sample of adipose tissue from just below the skin using a needle.

Drug: Lidocaine Hydrochloride
The anaesthetic that will be used to numb the site of the adipose tissue biopsy in the event it is included.

Other: Post-Prandial Meal Tests
Consume two successive meals with regular blood samples throughout the ensuing hours (2-3 hours each).

Radiation: DEXA Scan
Undergo a dual energy x-ray absorptiometry scan to examine body composition.

Other: Actiheart Calibration
Submaximal treadmill test to calibrate monitoring equipment.

Other: Daily Calorie Restriction
Reduce energy intake by 25% on a daily basis.

Experimental: Fasting with Weight Loss (IMF-WL)
During the intervention phase, participants randomised to this treatment condition will be asked to alternate between 24 hour cycles of feeding (consume 150% of normal energy intake) and fasting (no energy intake).
Device: Physical Activity Monitoring (Actiheart)
Monitor physical activity using an Actiheart monitor during the required periods.

Other: Energy Intake Monitoring
Monitor energy intake by weighing and recording all foods/drinks consumed during the required periods.

Other: Body Weight Monitoring
Monitor body weight during monitoring phase to ensure stability despite other monitoring activities.

Procedure: Intravenous Cannulation
Fitting of an intravenous cannula to a vein on the forearm for blood sampling during laboratory protocols.

Procedure: Adipose Tissue Biopsy
This is an optional feature which if included involves the removal of a 0.5 gram sample of adipose tissue from just below the skin using a needle.

Drug: Lidocaine Hydrochloride
The anaesthetic that will be used to numb the site of the adipose tissue biopsy in the event it is included.

Other: Post-Prandial Meal Tests
Consume two successive meals with regular blood samples throughout the ensuing hours (2-3 hours each).

Radiation: DEXA Scan
Undergo a dual energy x-ray absorptiometry scan to examine body composition.

Other: Actiheart Calibration
Submaximal treadmill test to calibrate monitoring equipment.

Other: Intermittent Fasting with Weight Loss
Alternate between 24 hour cycles of fasting and feeding with 150% of normal intake when feeding.

Experimental: Fasting without Weight Loss (IMF-WS)
During the intervention phase, participants randomised to this treatment condition will be asked to alternate between 24 hour cycles of feeding (consume 200% of normal energy intake) and fasting (no energy intake).
Device: Physical Activity Monitoring (Actiheart)
Monitor physical activity using an Actiheart monitor during the required periods.

Other: Energy Intake Monitoring
Monitor energy intake by weighing and recording all foods/drinks consumed during the required periods.

Other: Body Weight Monitoring
Monitor body weight during monitoring phase to ensure stability despite other monitoring activities.

Procedure: Intravenous Cannulation
Fitting of an intravenous cannula to a vein on the forearm for blood sampling during laboratory protocols.

Procedure: Adipose Tissue Biopsy
This is an optional feature which if included involves the removal of a 0.5 gram sample of adipose tissue from just below the skin using a needle.

Drug: Lidocaine Hydrochloride
The anaesthetic that will be used to numb the site of the adipose tissue biopsy in the event it is included.

Other: Post-Prandial Meal Tests
Consume two successive meals with regular blood samples throughout the ensuing hours (2-3 hours each).

Radiation: DEXA Scan
Undergo a dual energy x-ray absorptiometry scan to examine body composition.

Other: Actiheart Calibration
Submaximal treadmill test to calibrate monitoring equipment.

Other: Intermittent Fasting without Weight Loss
Alternate between 24 hour cycles of fasting and feeding with 200% of normal intake when feeding.




Primary Outcome Measures :
  1. Body Fat Percentage [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of body fat percentage (measured by dual-energy x-ray absorptiometry) from pre-intervention time-point to post-intervention time-point.

  2. Lean Body Mass [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of lean body mass (measured by dual-energy x-ray absorptiometry) from pre-intervention time-point to post-intervention time-point.

  3. Fasting Plasma Glucose Concentration [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of glucose concentration in the blood plasma at rest across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  4. Fasting Plasma Insulin Concentration [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of insulin concentration in the blood plasma at rest across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  5. Fasting Plasma Triglyceride Concentration [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of triglyceride concentration in the blood plasma at rest across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  6. Fasting Total Cholesterol Concentration [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of total cholesterol concentration in the blood plasma at rest across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  7. Fasting LDL Cholesterol Concentration [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of LDL cholesterol concentration in the blood plasma at rest across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  8. Fasting HDL Cholesterol Concentration [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of HDL cholesterol concentration in the blood plasma at rest across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  9. Fasting Leptin Concentration [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of leptin concentration in the blood plasma at rest across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  10. Fasting Adiponectin Concentration [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of adiponectin concentration in the blood plasma at rest across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  11. Fasting Resting Metabolic Rate [ Time Frame: Baseline - Pre - Post (7 weeks) ]
    Comparison of resting metabolic rate (measured by indirect calorimetry) across all three measurement points to ensure stability in the monitoring phase and examine change during the intervention phase.

  12. Post-Prandial Glucose AUC [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of the area under the plasma glucose curve seen during the 180 minute post-prandial period following a test meal conducted before and after the intervention phase.

  13. Post-Prandial Insulin AUC [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of the area under the plasma insulin curve seen during the 180 minute post-prandial period following a test meal conducted before and after the intervention phase.

  14. Post-Prandial Ghrelin AUC [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of the area under the plasma ghrelin curve seen during the 180 minute post-prandial period following a test meal conducted before and after the intervention phase.

  15. Post-Prandial Peptide-YY AUC [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of the area under the plasma peptide-YY curve seen during the 180 minute post-prandial period following a test meal conducted before and after the intervention phase.

  16. Physical Activity Energy Expenditure [ Time Frame: Monitoring - Intervention (7 weeks) ]
    Comparison of the mean physical activity energy expenditure values recorded using the Actiheart monitor during the monitoring and intervention phase to see the impact of the three treatments on physically active behaviours.

  17. Physical Activity Intensity [ Time Frame: Monitoring - Intervention (7 weeks) ]
    Comparison of the mean physical activity intensity values recorded using the Actiheart monitor during the monitoring and intervention phase to see the impact of the three treatments on physically active behaviours.

  18. CLOCK Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  19. NPAS2 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  20. PER1 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  21. CRY1 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  22. LEP Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  23. ADIPO-Q Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  24. IL-6 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  25. TNF Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  26. LPL Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  27. FABP4 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  28. PPARG Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  29. PPARGC1A Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  30. SREBP1C Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  31. FSP27 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  32. PRKAA1 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  33. ANGPTL4 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  34. HSL Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  35. ATGL Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  36. PNPLA3 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  37. CIDE-A Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  38. GLUT-4 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  39. AKT2 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  40. PDK4 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  41. SIRT1 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  42. SIRT3 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  43. UCP2 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  44. IGF1R Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  45. IRS1 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  46. IRS2 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  47. PIK3R1 Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  48. ChREBP Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  49. ACACA Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  50. FASN Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]
  51. ACADM Gene Expression in Subcutaneous Adipose Tissue [ Time Frame: Pre - Post (3 weeks) ]

Secondary Outcome Measures :
  1. Fasting Carbohydrate Oxidation [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of carbohydrate oxidation rate measured by indirect calorimetry before and after the intervention phase to examine the effect of the three treatment arms.

  2. Fasting Lipid Oxidation [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of lipid oxidation rate measured by indirect calorimetry before and after the intervention phase to examine the effect of the three treatment arms.

  3. Fasting Protein Oxidation [ Time Frame: Pre - Post (3 weeks) ]
    Comparison of protein oxidation rate measured by indirect calorimetry before and after the intervention phase to examine the effect of the three treatment arms.

  4. Post-Prandial Resting Metabolic Rate [ Time Frame: Pre-intervention 60, 120 and 180 minutes after meal - post-intervention 60, 120 and 180 minutes after meal (3 weeks) ]
    Comparison of post-prandial metabolic rate measured 60, 120 and 180 minutes after a test meal by indirect calorimetry before and after the intervention phase to examine the effect of the three treatment arms.

  5. Post-Prandial Carbohydrate Oxidation [ Time Frame: Pre-intervention 60, 120 and 180 minutes after meal - post-intervention 60, 120 and 180 minutes after meal (3 weeks) ]
    Comparison of post-prandial carbohydrate oxidation rate measured 60, 120 and 180 minutes after a test meal by indirect calorimetry before and after the intervention phase to examine the effect of the three treatment arms.

  6. Post-Prandial Lipid Oxidation [ Time Frame: Pre-intervention 60, 120 and 180 minutes after meal - post-intervention 60, 120 and 180 minutes after meal (3 weeks) ]
    Comparison of post-prandial lipid oxidation rate measured 60, 120 and 180 minutes after a test meal by indirect calorimetry before and after the intervention phase to examine the effect of the three treatment arms.

  7. Post-Prandial Protein Oxidation [ Time Frame: Pre-intervention 60, 120 and 180 minutes after meal - post-intervention 60, 120 and 180 minutes after meal (3 weeks) ]
    Comparison of post-prandial protein oxidation rate measured 60, 120 and 180 minutes after a test meal by indirect calorimetry before and after the intervention phase to examine the effect of the three treatment arms.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index of 20.5 kg/m2 or greater
  • Stable body weight for preceding three months (<3 kg increase or decrease)
  • Able and willing to safely comply with study procedures
  • Be able to attend the laboratory and willing to participate in necessary protocols
  • Be willing to undertake the durations of fasting required by the study
  • Have the capacity and willingness to provide informed consent (oral and written)

Exclusion Criteria:

  • Have a body weight greater than 120 kg
  • Will be undertaking any other fasting practices during their participation in the study (can enrol once stable weight returns after fasting is completed)
  • Currently engaged in or planning to engage in another weight management programme (e.g. weight watchers) or exercise programme (e.g. hypertrophy training or marathon training) during the study
  • Have previously suffered or are suffering from an eating disorder as assessed using the Eating Disorder Examination Questionnaire, Version 6.0 (Fairburn & Beglin, 2008)
  • Have been diagnosed with either type 1 or type 2 diabetes
  • Undertaking any form of medical treatment which may interfere with study variables (e.g. chemotherapy, liposuction, taking metformin, statins/other lipid-lowering medications)
  • Are peri-menopausal or menopausal (absence of menses for 3-24 months)
  • Pregnant, recently pregnant (within last 6 months), planning to become pregnant (within next six months), or currently breastfeeding.
  • Have donated more than 500 ml of blood in the last three months before the initial laboratory visit
  • Lack of metal capacity or language skills to independently understand/follow the study protocol
  • Physical disability which impacts study variables or ability to independently follow study protocol (e.g. paralysis)
  • Cannot consume test meals due to intolerances (i.e. lactose)
  • Report medical contraindications on the 'Physical Activity Readiness Questionnaire' and are unable to obtain medical approval for the treadmill test.

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): NCT02498002


Locations
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United Kingdom
University of Bath
Bath, Somerset, United Kingdom, BA2 7AY
Sponsors and Collaborators
University of Bath
Investigators
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Principal Investigator: James A Betts, BSc., Ph.D Fellow of the American College of Sports Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Iain Templeman, PhD Student (Health), University of Bath
ClinicalTrials.gov Identifier: NCT02498002     History of Changes
Other Study ID Numbers: IMF-02
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Keywords provided by Iain Templeman, University of Bath:
Diet
Fasting
Intermittent Fasting
Alternate-day Fasting
Physical Activity
Glucose
Insulin
Appetite
Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action