Effect of Speed of Weight Loss on Compensatory Mechanisms Activated During Weight Reduction

NCT01912742 | Completed

• 1 other identifier: 2013/888
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Weight loss; Speed of weight loss; Metabolic compensation; Diet therapy

Outcome Measures

Primary Outcomes (2)

• Appetite related hormones

  Appetite-related hormones (active ghrelin, PYY, GLP-1, CCK) will be measured in fasting and every 30 minutes up to 2,5 hours

  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).

• Body composition

  Body composition measured by air displacement plethysmography

  Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups)

Secondary Outcomes (2)

• Resting metabolic rate (RMR)

  Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups)

• Exercise efficiency

  Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups)

Study Arms (2)

Rapid weight loss group

EXPERIMENTAL

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)

Slow weight loss group

EXPERIMENTAL

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)

Interventions

Very-low calorie diet (VLCD) BEHAVIORAL

Rapid weight loss group

Low calorie diet (LCD) BEHAVIORAL

Slow weight loss group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Monash University: collaborator
• Portuguese Research Council: collaborator

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (1)

• Coutinho SR, With E, Rehfeld JF, Kulseng B, Truby H, Martins C. The impact of rate of weight loss on body composition and compensatory mechanisms during weight reduction: A randomized control trial. Clin Nutr. 2018 Aug;37(4):1154-1162. doi: 10.1016/j.clnu.2017.04.008. Epub 2017 Apr 25.

  PMID: 28479016 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bård Kulseng, MD PhD

  Norwegian University of Science and Technology

  STUDY DIRECTOR

• Catia Martins, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

NO (1)