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Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Intermittent energy restricted diet
Continuous energy restricted diet
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight loss, Intermittent energy restriction, Metabolic compensation, Diet therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adult (18-50 years old)
  • obese healthy volunteers (30<BMI<40 kg/m2)
  • weight stable on the last three months (<2kg), not currently dieting to lose weight and with an inactive lifestyle

Exclusion Criteria:

  • history of endocrine/cardiovascular/pulmonary/kidney disease
  • anaemia
  • milk intolerance
  • depression or other psychological disorders
  • eating disorders
  • drug or alcohol abuse within the last two years
  • current medication known to affect appetite or induce weight loss
  • a planned surgery during the study period
  • participating in another research study

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intermittent energy restricted diet

Continuous energy restricted diet

Arm Description

The intermittent energy restricted group will undergo 3 nonconsecutive days of partial fasting per week. During the 3 days of partial fasting, participants will be asked to consume a very-low calorie diet (VLCD) providing 550kcal/day for women and 650kcal/day for men. The VLCD products provide 110kcal/pack and include a variety of shakes, smoothies and soups. For the feeding days a diet matching energy needs will be prescribed, using meal replacements (such as smoothies, soups and cereal bars) and conventional food. Drinking at least 2.5 liters of non-caloric liquids will be recommended.

The continuous energy restricted group will be prescribed a low calorie diet (LCD) with 33% energy restriction, using meal replacements (such as smoothies, soups and cereal bars) and conventional food. The diets' macronutrient composition of the two groups will be matched (50% carbohydrates, 20% protein and 30% fat).

Outcomes

Primary Outcome Measures

Appetite related hormones
Appetite-related hormones (active Ghrelin, PYY, GLP-1, CCK) will be measured in fasting and every 30 minutes up to 2,5 hours.

Secondary Outcome Measures

Resting metabolic rate (RMR)
RMR measured by indirect calorimetry
Exercise efficiency
Exercise efficiency measured by graded exercise on a bike
Body composition
RMR measured by indirect calorimetry
Body composition
RMR measured by indirect calorimetry
Body composition
RMR measured by indirect calorimetry

Full Information

First Posted
June 17, 2014
Last Updated
April 28, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
Monash University, Portuguese Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT02169778
Brief Title
Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
Official Title
Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Monash University, Portuguese Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity has become a global epidemic with huge public health implications. Although clinical significant weight loss can be achieved by a combination of diet and behavioral modification, strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are activated, which compromise weight loss maintenance and increase the risk of relapse. The aim of this project is to compare the effects of intermittent versus continuous energy restriction on the compensatory responses previously described using two low calory diets, with a similar macronutrient distribution. More specifically, this study will analyze, in the short-term, if an intermittent energy restricted diet is associated with less appetite and low reduction in energy expenditure when compared with a continuous energy restricted diet. This project can bring large practical benefits concerning the design of weight loss programs to minimize weight relapse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss, Intermittent energy restriction, Metabolic compensation, Diet therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent energy restricted diet
Arm Type
Experimental
Arm Description
The intermittent energy restricted group will undergo 3 nonconsecutive days of partial fasting per week. During the 3 days of partial fasting, participants will be asked to consume a very-low calorie diet (VLCD) providing 550kcal/day for women and 650kcal/day for men. The VLCD products provide 110kcal/pack and include a variety of shakes, smoothies and soups. For the feeding days a diet matching energy needs will be prescribed, using meal replacements (such as smoothies, soups and cereal bars) and conventional food. Drinking at least 2.5 liters of non-caloric liquids will be recommended.
Arm Title
Continuous energy restricted diet
Arm Type
Experimental
Arm Description
The continuous energy restricted group will be prescribed a low calorie diet (LCD) with 33% energy restriction, using meal replacements (such as smoothies, soups and cereal bars) and conventional food. The diets' macronutrient composition of the two groups will be matched (50% carbohydrates, 20% protein and 30% fat).
Intervention Type
Behavioral
Intervention Name(s)
Intermittent energy restricted diet
Intervention Type
Behavioral
Intervention Name(s)
Continuous energy restricted diet
Primary Outcome Measure Information:
Title
Appetite related hormones
Description
Appetite-related hormones (active Ghrelin, PYY, GLP-1, CCK) will be measured in fasting and every 30 minutes up to 2,5 hours.
Time Frame
12 weeks after the intervention
Secondary Outcome Measure Information:
Title
Resting metabolic rate (RMR)
Description
RMR measured by indirect calorimetry
Time Frame
12 weeks after the intervention
Title
Exercise efficiency
Description
Exercise efficiency measured by graded exercise on a bike
Time Frame
12 weeks after the intervention
Title
Body composition
Description
RMR measured by indirect calorimetry
Time Frame
12 weeks after the intervention
Title
Body composition
Description
RMR measured by indirect calorimetry
Time Frame
At 6 months from baseline
Title
Body composition
Description
RMR measured by indirect calorimetry
Time Frame
At 1 year from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult (18-50 years old) obese healthy volunteers (30<BMI<40 kg/m2) weight stable on the last three months (<2kg), not currently dieting to lose weight and with an inactive lifestyle Exclusion Criteria: history of endocrine/cardiovascular/pulmonary/kidney disease anaemia milk intolerance depression or other psychological disorders eating disorders drug or alcohol abuse within the last two years current medication known to affect appetite or induce weight loss a planned surgery during the study period participating in another research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bård Kulseng, MD, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28446382
Citation
Coutinho SR, Halset EH, Gasbakk S, Rehfeld JF, Kulseng B, Truby H, Martins C. Compensatory mechanisms activated with intermittent energy restriction: A randomized control trial. Clin Nutr. 2018 Jun;37(3):815-823. doi: 10.1016/j.clnu.2017.04.002. Epub 2017 Apr 7.
Results Reference
result
PubMed Identifier
35772219
Citation
Castela I, Rodrigues C, Ismael S, Barreiros-Mota I, Morais J, Araujo JR, Marques C, Silvestre MP, Angelo-Dias M, Martins C, Borrego LM, Monteiro R, Coutinho SR, Calhau C, Faria A, Pestana D, Martins C, Teixeira D. Intermittent energy restriction ameliorates adipose tissue-associated inflammation in adults with obesity: A randomised controlled trial. Clin Nutr. 2022 Aug;41(8):1660-1666. doi: 10.1016/j.clnu.2022.06.021. Epub 2022 Jun 18.
Results Reference
derived
PubMed Identifier
33512717
Citation
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Results Reference
derived

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Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction

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