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Completed

NCT Number: NCT04065243

Experimental Overfeeding in Humans

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

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Key information

Conditions

Overfed Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, Norrebro, 2200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Overfeeding diet

Other

Two weeks of overfeeding

isocaloric diet

Other

Two weeks of isocaloric weight maintenance

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Body weight

    Time frame: 5 weeks

    Body weight will be measured (in kilograms) daily during the intervention using electronic Fitbit Aria 2 weight scale.

  2. Fat biopsy from subcutaneous adipose tissue before and after 2 weeks of overfeeding

    Time frame: 2 weeks

    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.

  3. 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

    Time frame: 2 weeks

    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.

  4. Body composition in 40 subjects before and after overfeeding

    Time frame: 3 weeks

    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.

  5. Mixed meal test

    Time frame: 2 weeks

    Before and after the intervention a mixed meal test will be performed

  6. Changes in blood metabolome 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding

    Time frame: 5 weeks

    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.

  7. Activity profile of 40 subjects during the 5 week study period

    Time frame: 5 weeks

    Assessment of daily physical activity levels (wearables and doubly-labelled water)

  8. Detection of circulating factors

    Time frame: 5 weeks

    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.

  9. Gut microbiome profile before and after 14 days of overfeeding

    Time frame: 2 weeks

    Feces samples will be collected before and after 14 days of overfeeding and microbiome composition will be analyzed by using UPLC-MS/GC-MS.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Acronym: ExpO

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2019
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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