OverfedExpONCT04065243
Experimental Overfeeding in Humans
A study testing Overfeeding diet and Isocaloric diet in people with Overfed and Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The objective of this study is to determine the homeostatic mechanisms that counteract weight gain in response to experimental overfeeding. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Overfeeding diet and Isocaloric diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Aug 2019to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female otherwise healthy subjects
- 20-40 years of age
- BMI (Body mass index) between 22-30 kg/m2
Who cannot join
- Present or previous cardiovascular disease, diabetes or thyroid-disease
- smoking
- more than 3 hours of planned physical activity per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Changes in Response to Experimental Overfeeding: A Randomized Intervention Study
The objective of this study is to determine the homeostatic mechanisms that counteract weight gain in response to experimental overfeeding.
Read the 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.
- Being tested
- Overfeeding diet, Isocaloric diet
- Medical subject headings
- Overnutrition, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overfeeding dietOther
Two weeks of overfeeding
Isocaloric dietOther
Two weeks of isocaloric weight maintenance
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Subjects in this group will have a daily energy intake equivalent of 100 % of their calculated normal daily energy intake. Receives: Other: Isocaloric diet |
| Overfed group | Experimental | Subjects in this group will have a daily energy intake equivalent of 150 % of their calculated normal daily energy intake. Receives: Other: Overfeeding diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Secondary outcomes (9)
Body weight
Body weight will be measured (in kilograms) daily during the intervention using electronic Fitbit Aria 2 weight scale.
Measured: 5 weeks
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.
Measured: 2 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
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.
Measured: 2 weeks
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.
Measured: 3 weeks
Mixed meal test
Before and after the intervention a mixed meal test will be performed
Measured: 2 weeks
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.
Measured: 5 weeks
Activity profile of 40 subjects during the 5 week study period
Assessment of daily physical activity levels (wearables and doubly-labelled water)
Measured: 5 weeks
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.
Measured: 5 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start22 Aug 2019
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverfedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoffer Clemmensen, University of Copenhagen
- Investigators
- Christoffer Clemmensen, Assoc. Prof., Principal investigator, Assoc. prof. NNF Center for Basic Metabolic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065243
- Sponsor's protocol ID
- ExpO
- Acronym
- ExpO
- Status last verified
- May 2023
- First submitted
- 8 Aug 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Changes in Response to Experimental Overfeeding: A Randomized Intervention Study
- ClinicalTrials.gov ID
- NCT04065243
- Acronym / sponsor ID
- ExpO / ExpO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Isocaloric dietSubjects in this group will have a daily energy intake equivalent of 100 % of their calculated normal daily energy intake. |
| Overfed group | Experimental | Other: Overfeeding dietSubjects in this group will have a daily energy intake equivalent of 150 % of their calculated normal daily energy intake. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female otherwise healthy subjects
- 20-40 years of age
- BMI (Body mass index) between 22-30 kg/m2
Key exclusion criteria (3 listed)
- Present or previous cardiovascular disease, diabetes or thyroid-disease
- smoking
- more than 3 hours of planned physical activity per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overfeeding dietTwo weeks of overfeeding | Other | Overfed group |
| Isocaloric dietTwo weeks of isocaloric weight maintenance | Other | Control group |
Primary outcome
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.
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.
9 secondary outcomes
Body weight
Time frame: 5 weeks
Fat biopsy from subcutaneous adipose tissue before and after 2 weeks of overfeeding
Time frame: 2 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
Time frame: 2 weeks
Body composition in 40 subjects before and after overfeeding
Time frame: 3 weeks
Mixed meal test
Time frame: 2 weeks
Changes in blood metabolome 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding
Time frame: 5 weeks
Activity profile of 40 subjects during the 5 week study period
Time frame: 5 weeks
Detection of circulating factors
Time frame: 5 weeks
Gut microbiome profile before and after 14 days of overfeeding
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Clemmensen, Assoc. Prof. principal investigator
Assoc. prof. NNF Center for Basic Metabolic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overfeeding diet and Isocaloric diet in people with Overfed and Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood protein patterns using proteomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.