Overweight and ObesityEAT 2NCT04583514
Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding
A study testing Overfeeding in people with Overweight and Obesity and Metabolic Syndrome, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ… Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Metabolic Syndrome
- What is being tested?
- Overfeeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and pre-menopausal women
- 18-42 years of age
- BMI 23-35 kg/m2 (± 0.5 will be accepted)
- Are willing to drink deuterium-labeled water (2H2O) for 8 weeks
- Are willing to be randomized to either a CTL or 30% OF group
- For women, if not using pharmaceutical (hormonal) contraception (i.e. birth control pills, vaginal ring, injections, or implant), must agree to use either a double barrier method as a form of birth control to prevent pregnancy (i.e. male condom with spermicide, with or without cervical cap or diaphragm); use implants or intrauterine contraceptive devices; have a tubal ligation (surgically sterile); practice abstinence; or be in an established relationship with a vasectomized or same sex partner during the entire duration of the study
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- Must be willing to adhere to all study procedures, including attendance at all study visits
- If enrolled, agree to maintain the same level of physical activity throughout the duration of the study
- Must be willing to have blood stored for future research
Who cannot join
- Unstable weight in the last 3 months (± ~5% weight change)
- Diagnosis of Type 1 or 2 diabetes or a fasting blood glucose > 110 mg/dL
- Average screening blood pressure > 140/90 mmHg
- Diagnosis of major organ disease (e.g. heart, kidney, lung, thyroid, liver disease) or abnormal liver enzymes that are, in the opinion of the MI, clinically significant and represent a problem for study inclusion.
- Self-reported positive test for human immunodeficiency virus, hepatitis B or hepatitis C
- Any current or previous eating disorders
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- Chronic use of systemic glucocorticoids (steroids), systemic adrenergic-stimulating agents, beta-blockers, antipsychotic medications, thiazolidinediones and other medications that may cause clinically significant weight gain or loss)
- Chronic use of prescription weight loss medications or over the counter weight loss medications which, in the opinion of the MI, will impact the study
- Chronic use of anti-depressant medications for less than 3 months
- Chronic smokers or users of tobacco products who cannot abstain for the duration of the inpatient visits
- Previous bariatric or other surgeries for obesity
- Had cancer in the last 5 years (some skin cancers acceptable)
- Pregnancy, breastfeeding, or planned pregnancy for the upcoming 6 months
- Partial or full hysterectomy
- PCOS
- Diagnosed psychotic conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70809
Ursula White, Ph.D., 225-763-2656, ursula.white@pbrc.edu
About this study
Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Being tested
- Control, Overfeeding
- Keywords
- Overweight, Adipose tissue, Subcutaneous abdominal, Subcutaneous femoral, Adipocyte, Adipose turnover, Adipose kinetics, Adipogenesis, Ectopic fat, Insulin sensitivity, Deuterium
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Weight-stable Control group
OverfeedingBehavioural
30% Overfeeding group
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | The control group will be expected to maintain their weight within 1 kg of baseline weight throughout the duration of the study. Receives: Behavioral: Control |
| Overfeeding | Experimental | The overfeeding group will be subjected to a similar relative change in energy intake, in which their dietary intake will be 30% more kcal/d than needed for weight maintenance. Receives: Behavioral: Overfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue expansion and remodeling -- in vivo adipocyte formation
Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. The primary outcome is to assess changes in new adipocyte formation in vivo and other mechanisms of adipose expansion and remodeling in response to 30% overfeeding (OF group) relative to the weight-stable CTL group.
Measured: 8 weeks
Secondary outcomes (2)
Adipose tissue expansion and remodeling -- in vivo triglyceride synthesis
Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is incorporated into the glycerol component of the adipose, providing a measure of new triglyceride synthesis. A secondary outcome is to assess changes in triglyceride synthesis in vivo and other mechanisms of adipose expansion and remodeling in response to 30% overfeeding (OF group) relative to the weight-stable CTL group.
Measured: 8 weeks
Cardiometabolic health outcomes
A secondary outcome is to investigate the correlation between mechanisms of adipose tissue expansion and remodeling with changes in metabolic health outcomes (i.e. abdominal adiposity; insulin sensitivity; ectopic lipid) in response to 30% OF relative to the CTL group.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start15 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ursula White, Pennington Biomedical Research Center
- Investigators
- Ursula White, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583514
- Sponsor's protocol ID
- PBRC 2019-051
- Other IDs
- R01DK121944
- Acronym
- EAT 2
- Status last verified
- Apr 2026
- First submitted
- 5 Oct 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding
- ClinicalTrials.gov ID
- NCT04583514
- Acronym / sponsor ID
- EAT 2 / PBRC 2019-051
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Keywords
- Overweight, Adipose tissue, Subcutaneous abdominal, Subcutaneous femoral, Adipocyte, Adipose turnover, Adipose kinetics, Adipogenesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Oct 2020 (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.
Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: ControlThe control group will be expected to maintain their weight within 1 kg of baseline weight throughout the duration of the study. |
| Overfeeding | Experimental | Behavioral: OverfeedingThe overfeeding group will be subjected to a similar relative change in energy intake, in which their dietary intake will be 30% more kcal/d than needed for weight maintenance. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men and pre-menopausal women
- 18-42 years of age
- BMI 23-35 kg/m2 (± 0.5 will be accepted)
- Are willing to drink deuterium-labeled water (2H2O) for 8 weeks
- Are willing to be randomized to either a CTL or 30% OF group
Key exclusion criteria (16 listed)
- Unstable weight in the last 3 months (± ~5% weight change)
- Diagnosis of Type 1 or 2 diabetes or a fasting blood glucose > 110 mg/dL
- Average screening blood pressure > 140/90 mmHg
- Diagnosis of major organ disease (e.g. heart, kidney, lung, thyroid, liver disease) or abnormal liver enzymes that are, in the opinion of the MI, clinically significant and represent a problem for study inclusion.
- Self-reported positive test for human immunodeficiency virus, hepatitis B or hepatitis C
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 |
|---|---|---|
| ControlWeight-stable Control group | Behavioural | Control |
| Overfeeding30% Overfeeding group | Behavioural | Overfeeding |
Primary outcome
Adipose tissue expansion and remodeling -- in vivo adipocyte formation
Time frame: 8 weeks
Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. The primary outcome is to assess changes in new adipocyte formation in vivo and other mechanisms of adipose expansion and remodeling in response to 30% overfeeding (OF group) relative to the weight-stable CTL group.
2 secondary outcomes
Adipose tissue expansion and remodeling -- in vivo triglyceride synthesis
Time frame: 8 weeks
Cardiometabolic health outcomes
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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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.
Ursula White, Ph.D. principal investigator
Pennington Biomedical Research Center
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 in people with Overweight and Obesity and Metabolic Syndrome, run by Pennington Biomedical Research Center at 1 site in United States.
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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ursula White, Ph.D. (225-763-2656, ursula.white@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipose tissue expansion and remodeling -- in vivo adipocyte formation (time frame: 8 weeks). 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 8 Apr 2026.