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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Intermittent energy restricted diet; Behavioral: Continuous energy restricted diet

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Intermittent energy restricted diet
Experimental: 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).	Behavioral: Continuous energy restricted diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting metabolic rate (RMR)	RMR measured by indirect calorimetry	12 weeks after the intervention
Exercise efficiency	Exercise efficiency measured by graded exercise on a bike	12 weeks after the intervention
Body composition	RMR measured by indirect calorimetry	12 weeks after the intervention
Body composition	RMR measured by indirect calorimetry	At 6 months from baseline
Body composition	RMR measured by indirect calorimetry	At 1 year from baseline

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Monash University; Portuguese Research Council
• Investigators: Study Director: Bård Kulseng, MD, PhD, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Weight loss; Diet therapy; Metabolic compensation; Intermittent energy restriction
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2014/754

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No