Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
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ClinicalTrials.gov Identifier: NCT02169778 |
Recruitment Status :
Completed
First Posted : June 23, 2014
Last Update Posted : May 2, 2017
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Condition or disease | Intervention/treatment | Phase |
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Obesity | Behavioral: Intermittent energy restricted diet Behavioral: Continuous energy restricted diet | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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).
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Behavioral: Continuous energy restricted diet |
- 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.
- Resting metabolic rate (RMR) [ Time Frame: 12 weeks after the intervention ]RMR measured by indirect calorimetry
- Exercise efficiency [ Time Frame: 12 weeks after the intervention ]Exercise efficiency measured by graded exercise on a bike
- Body composition [ Time Frame: 12 weeks after the intervention ]RMR measured by indirect calorimetry
- Body composition [ Time Frame: At 6 months from baseline ]RMR measured by indirect calorimetry
- Body composition [ Time Frame: At 1 year from baseline ]RMR measured by indirect calorimetry

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Norway | |
Norwegian University of Science and Technology | |
Trondheim, Norway |
Study Director: | Bård Kulseng, MD, PhD | Norwegian University of Science and Technology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT02169778 |
Other Study ID Numbers: |
2014/754 |
First Posted: | June 23, 2014 Key Record Dates |
Last Update Posted: | May 2, 2017 |
Last Verified: | April 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Weight loss Intermittent energy restriction Metabolic compensation Diet therapy |
Weight Loss Body Weight Changes Body Weight |