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

NCT ID: NCT02169778

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intermittent energy restricted diet

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.

Group Type EXPERIMENTAL

Intermittent energy restricted diet

Intervention Type BEHAVIORAL

Continuous energy restricted diet

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).

Group Type EXPERIMENTAL

Continuous energy restricted diet

Intervention Type BEHAVIORAL

Interventions

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Intermittent energy restricted diet

Intervention Type BEHAVIORAL

Continuous energy restricted diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Monash University

OTHER

Sponsor Role collaborator

Portuguese Research Council

UNKNOWN

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bård Kulseng, MD, PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Norwegian University of Science and Technology

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 28446382 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35772219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33512717 (View on PubMed)

Other Identifiers

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2014/754

Identifier Type: -

Identifier Source: org_study_id

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