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

Obesity Clinical Trial

— FVS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912742
• Other study ID #: 2013/888
• Status: Completed
• Phase: N/A
• First received: July 29, 2013
• Last updated: September 19, 2017
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Very-low calorie diet (VLCD)

• Low calorie diet (LCD)

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Monash University, Portuguese Research Council

Country where clinical trial is conducted

Norway, 

References & 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. 2017 Apr 25. pii: S0261-5614(17)30147-4. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Resting metabolic rate (RMR)	RMR measured by indirect calorimetry	Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups)
Secondary	Exercise efficiency	Exercise efficiency measured by graded exercise on a bike	Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups)