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History of Changes for Study: NCT02169778
Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
Latest version (submitted April 28, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 19, 2014 None (earliest Version on record)
2 January 16, 2015 Study Status
3 February 5, 2015 Study Status and Study Design
4 April 11, 2016 Recruitment Status and Study Status
5 April 28, 2017 Study Status, Oversight and References
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Study NCT02169778
Submitted Date:  June 19, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2014/754
Brief Title: Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
Official Title: Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2014
Overall Status: Active, not recruiting
Study Start: August 2013
Primary Completion: August 2015 [Anticipated]
Study Completion: December 2015 [Anticipated]
First Submitted: June 17, 2014
First Submitted that
Met QC Criteria:
June 19, 2014
First Posted: June 23, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 19, 2014
Last Update Posted: June 23, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Norwegian University of Science and Technology
Responsible Party: Sponsor
Collaborators: Monash University
Portuguese Research Council
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Obesity
Keywords: Weight loss
Intermittent energy restriction
Metabolic compensation
Diet therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Bård Kulseng, MD, PhD
Study Director
Norwegian University of Science and Technology
Locations: Norway
Norwegian University of Science and Technology
Trondheim, Norway
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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