Clinical trial NCT04065243: Experimental Overfeeding in Humans
Official title: Metabolic Changes in Response to Experimental Overfeeding: A Randomized Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overfed
Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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
* smoking
* more than 3 hours of planned physical activity per week

Primary outcomes:
measure: Changes in blood protein patterns using proteomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding
timeFrame: 5 weeks
measure: Changes in blood peptide patterns using peptidomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding
timeFrame: 5 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 5 weeks
measure: Fat biopsy from subcutaneous adipose tissue before and after 2 weeks of overfeeding
timeFrame: 2 weeks
measure: 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
timeFrame: 2 weeks
measure: Body composition in 40 subjects before and after overfeeding
timeFrame: 3 weeks
measure: Mixed meal test
timeFrame: 2 weeks
measure: Changes in blood metabolome 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding
timeFrame: 5 weeks
measure: Activity profile of 40 subjects during the 5 week study period
timeFrame: 5 weeks
measure: Detection of circulating factors
timeFrame: 5 weeks
measure: Gut microbiome profile before and after 14 days of overfeeding
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: Norrebro
Study officials:
affiliation: Assoc. prof. NNF Center for Basic Metabolic Research
name: Christoffer Clemmensen, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: