Metabolic Changes in Response to Experimental Overfeeding: A Randomized Intervention Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Changes in blood peptide patterns using peptidomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding
Study Overview
Brief Summary
The objective of this study is to determine the homeostatic mechanisms that counteract weight gain in response to experimental overfeeding.
Detailed Description
The homeostatic regulation of body weight implies that biological processes have evolved to protect energy stores from changes to the food environment. Accordingly, many individuals remain remarkably weight stable over years without carefully considering how much they eat or how much energy they expend, which has given rise to the theory that body weight is regulated around an individual biological 'set point'. Notably, overfeeding humans in experimentally controlled conditions, support this phenomenon, but the underlying mechanisms are unknown.
To systematically map out the components of the overfed state, the investigators will execute a 2-week randomized controlled overfeeding trial in lean and overweight individuals. The trial is preceded by a 1-week lead-in period and followed by a 2-wk controlled ad libitum study period. The comparison between lean and overweight subjects, men and women, enables the determination of whether a differential response in overfeeding-induced signals is present in relation to BMI and sex.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Masking Description
Body weight and other anthropometric data are not masked.
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female otherwise healthy subjects
- •20-40 years of age
- •BMI (Body mass index) between 22-30 kg/m2
Exclusion Criteria
- •Present or previous cardiovascular disease, diabetes or thyroid-disease
- •more than 3 hours of planned physical activity per week
Arms & Interventions
Control group
Subjects in this group will have a daily energy intake equivalent of 100 % of their calculated normal daily energy intake.
Intervention: Isocaloric diet (Other)
Overfed group
Subjects in this group will have a daily energy intake equivalent of 150 % of their calculated normal daily energy intake.
Intervention: Overfeeding diet (Other)
Outcomes
Primary Outcomes
Changes in blood peptide patterns using peptidomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding
Time Frame: 5 weeks
Blood will be collected for peptidomics at screening, at baseline, during the overfeeding intervention and during the 2-week ad libitum intervention. Samples will be measured using LCMS instrumentation consisting of a nanoelectrospray ion source to a Q Exactive HF mass spectrometer.
Changes in blood protein patterns using proteomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding
Time Frame: 5 weeks
Blood will be collected for proteomics at screening, at baseline, during the overfeeding intervention and during the 2-week ad libitum intervention. Samples will be measured using LCMS instrumentation consisting of a nanoelectrospray ion source to a Q Exactive HF mass spectrometer.
Secondary Outcomes
- Body weight(5 weeks)
- Fat biopsy from subcutaneous adipose tissue before and after 2 weeks of overfeeding(2 weeks)
- Body composition in 40 subjects before and after overfeeding(3 weeks)
- Microdialysate from subcutaneous adipose tissue before and after 2 weeks of overfeeding. The samples will be used for detection of known and unknown secreted factors(2 weeks)
- Activity profile of 40 subjects during the 5 week study period(5 weeks)
- Mixed meal test(2 weeks)
- Changes in blood metabolome 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding(5 weeks)
- Gut microbiome profile before and after 14 days of overfeeding(2 weeks)
- Detection of circulating factors(5 weeks)
Investigators
Christoffer Clemmensen
Associate Professor
University of Copenhagen