Experimental Overfeeding in Humans

Obesity Clinical Trial

— ExpO  

Official title:

Metabolic Changes in Response to Experimental Overfeeding: A Randomized Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065243
• Other study ID #: ExpO
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the homeostatic mechanisms that counteract weight gain in response to experimental overfeeding.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overfed

Intervention

Other:
• Overfeeding diet
Two weeks of overfeeding
• Isocaloric diet
Two weeks of isocaloric weight maintenance

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen	Norrebro

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood protein patterns using proteomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding	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.	5 weeks
Primary	Changes in blood peptide patterns using peptidomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding	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.	5 weeks
Secondary	Body weight	Body weight will be measured (in kilograms) daily during the intervention using electronic Fitbit Aria 2 weight scale.	5 weeks
Secondary	Fat biopsy from subcutaneous adipose tissue before and after 2 weeks of overfeeding	Fat biopsies are obtained using Bergström biopsy needle from subcutaneous adipose tissue in the abdominal region before and after 14 days of overfeeding to assess regulated enzymes and proteins.	2 weeks
Secondary	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	Microdialysates are collected from micro dialysis catheters inserted into the subcutaneous adipose tissue in the abdominal region before and after 14 days of overfeeding to assess regulated enzymes and proteins.	2 weeks
Secondary	Body composition in 40 subjects before and after overfeeding	Body composition will be measured using Dual-Energy X-ray Absorptiometry (DXA) at screening (1 week before baseline), at baseline and after 14 days of overfeeding. The DXA scan enables the detection of body lean mass and body fat mass in kg.	3 weeks
Secondary	Mixed meal test	Before and after the intervention a mixed meal test will be performed	2 weeks
Secondary	Changes in blood metabolome 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding	Blood will be collected for metabolomics at screening, at baseline, during the overfeeding intervention and during the 2-week ad libitum intervention. Metabolomics will be performed using Mass Spectrometry.	5 weeks
Secondary	Activity profile of 40 subjects during the 5 week study period	Assessment of daily physical activity levels (wearables and doubly-labelled water)	5 weeks
Secondary	Detection of circulating factors	The investigators will measure the concentration of known circulating factors from fasted blood samples and from blood samples obtained during mixed meal test, such as: Glucose, insulin, hsCRP, Hba1c, cortisol, ACTH, lactate, fatty acids, triglycerides, glycerol, catecholamines, leptin, ghrelin, adiponectin, glucagon, GDF15, FGF21, FGF19, GIP, GLP-1, PYY, CCK, interleukins, cytokines, tissue-kines, T3, T4, TSH, cholesterol.	5 weeks
Secondary	Gut microbiome profile before and after 14 days of overfeeding	Feces samples will be collected before and after 14 days of overfeeding and microbiome composition will be analyzed by using UPLC-MS/GC-MS.	2 weeks