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OpenTrials
Completed

NCT Number: NCT02169778

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent energy restricted diet

Behavioral

Continuous energy restricted diet

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Monash University
  • Portuguese Research Council

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 23, 2014
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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