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

NCT02169778 | Completed

• 1 other identifier: 2014/754
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Weight loss; Intermittent energy restriction; Metabolic compensation; Diet therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after the intervention

Secondary Outcomes (5)

• Resting metabolic rate (RMR)

  12 weeks after the intervention

• Exercise efficiency

  12 weeks after the intervention

• Body composition

  12 weeks after the intervention

• Body composition

  At 6 months from baseline

• Body composition

  At 1 year from baseline

Study Arms (2)

Intermittent energy restricted diet

EXPERIMENTAL

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.

Behavioral: Intermittent energy restricted diet

Continuous energy restricted diet

EXPERIMENTAL

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).

Behavioral: Continuous energy restricted diet

Interventions

Intermittent energy restricted diet BEHAVIORAL

Intermittent energy restricted diet

Continuous energy restricted diet BEHAVIORAL

Continuous energy restricted diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Monash University: collaborator
• Portuguese Research Council: collaborator

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (3)

• 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.

  PMID: 28446382 RESULT

• 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.

  PMID: 35772219 DERIVED

• 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.

  PMID: 33512717 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Bård Kulseng, MD, PhD

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 23, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

NO (1)