Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02169778
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : May 2, 2017
Sponsor:
Collaborators:
Monash University
Portuguese Research Council
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Intermittent energy restricted diet Behavioral: Continuous energy restricted diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
Actual Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Appetite related hormones [ Time Frame: 12 weeks after the intervention ]
    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 :
  1. Resting metabolic rate (RMR) [ Time Frame: 12 weeks after the intervention ]
    RMR measured by indirect calorimetry

  2. Exercise efficiency [ Time Frame: 12 weeks after the intervention ]
    Exercise efficiency measured by graded exercise on a bike

  3. Body composition [ Time Frame: 12 weeks after the intervention ]
    RMR measured by indirect calorimetry

  4. Body composition [ Time Frame: At 6 months from baseline ]
    RMR measured by indirect calorimetry

  5. Body composition [ Time Frame: At 1 year from baseline ]
    RMR measured by indirect calorimetry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169778


Locations
Layout table for location information
Norway
Norwegian University of Science and Technology
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Monash University
Portuguese Research Council
Investigators
Layout table for investigator information
Study Director: Bård Kulseng, MD, PhD Norwegian University of Science and Technology

Publications of Results:
Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02169778     History of Changes
Other Study ID Numbers: 2014/754
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Weight loss
Intermittent energy restriction
Metabolic compensation
Diet therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms