Effect of Speed of Weight Loss on Compensatory Mechanisms Activated During Weight Reduction (FVS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Monash University
Portuguese Research Council
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01912742
First received: July 29, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

Obesity has become a global epidemic with huge public health implications. Although clinical significant weight loss (WL) 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 WL maintenance and increase the risk of relapse. The aim of this project is to investigate the potential role of WL rate in modulating such responses. More specifically, the investigators want to determine if a similar WL achieved rapidly vs slowly induce the same compensatory responses to weight reduction. A secondary aim is to assess if speed of weight loss can influence motivation. A large battery of assessments will be performed before and after weight reduction including body composition, resting metabolic rate, substrate oxidation, exercise efficiency, fasting and postprandial release of several appetite-regulating hormones, subjective feelings of hunger and fullness and motivation. This project can bring large practical benefits concerning the design of weight loss programs to minimize weight relapse.


Condition Intervention
Obesity
Behavioral: Very-low calorie diet (VLCD)
Behavioral: Low calorie diet (LCD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Speed of Weight Loss on Compensatory Mechanisms Activated During Weight Reduction

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Appetite related hormones [ Time Frame: Before the start of the study and again at week 2 and 4 (VLCD group) and 4 and 8 (LCD group). And also, on week 12 (for both groups). ] [ Designated as safety issue: No ]
    Appetite-related hormones (active ghrelin, PYY, GLP-1, CCK) will be measured in fasting and every 30 minutes up to 2,5 hours

  • Body composition [ Time Frame: Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups) ] [ Designated as safety issue: No ]
    Body composition measured by air displacement plethysmography


Secondary Outcome Measures:
  • Resting metabolic rate (RMR) [ Time Frame: Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups) ] [ Designated as safety issue: No ]
    RMR measured by indirect calorimetry

  • Exercise efficiency [ Time Frame: Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups) ] [ Designated as safety issue: No ]
    Exercise efficiency measured by graded exercise on a bike


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapid weight loss group
The rapid weight loss group will follow a commercial very-low calorie diet (VLCD) during 4 weeks. The participants allocated to this group will follow a 550 (women) - 660 (men) kcal/day diet. The VLCD products provide 110kcal/pack and include a variety of milkshakes, smoothies and soups. In addition to VLCD products, calorie-free drinks and some low-starch vegetables (maximum 2 cups/day) will be allowed. Drinking at least 2.5 liters of non-caloric liquids will be recommended.
Behavioral: Very-low calorie diet (VLCD)
Experimental: Slow weight loss group
The slow weight loss group will be prescribed an individualized low calorie diet (LCD) (1200-1500kcal/day), during 8 weeks, using meal replacements (such as smoothies, soups and cereal bars) and conventional foods. The macronutrient composition will be matched with that of the VLCD.
Behavioral: Low calorie diet (LCD)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (18-50 years old)
  • Obese healthy volunteers (30<BMI<45 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, gout, milk intolerance, depression or other psychological disorders, eating disorders, drug or alcohol abuse within the last two years and current medication known to affect appetite or induce weight loss. Those with a planned surgery during the study period or participating in another research study will also not be accepted to take part in this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912742

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Monash University
Portuguese Research Council
Investigators
Study Director: Bård Kulseng, MD PhD Norwegian University of Science and Technology
Principal Investigator: Catia Martins, PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01912742     History of Changes
Other Study ID Numbers: 2013/888
Study First Received: July 29, 2013
Last Updated: February 11, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Weight loss
Speed of weight loss
Metabolic compensation
Diet therapy

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 17, 2014