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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169778
• Other study ID #: 2014/754
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: April 28, 2017
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Intermittent energy restricted diet

• Continuous energy restricted diet

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Monash University, Portuguese Research Council

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Coutinho SR, Halset EH, Gåsbakk S, Rehfeld JF, Kulseng B, Truby H, Martins C. Compensatory mechanisms activated with intermittent energy restriction: A randomized control trial. Clin Nutr. 2017 Apr 7. pii: S0261-5614(17)30125-5. doi: 10.1016/j.clnu.2017.0 — View Citation

Outcome

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