Overfeeding Effects on Obesity

(EAT 2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ursula White, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Pennington Biomedical Research Center

Must not be taking: Steroids, Antipsychotics, Antidepressants, others

Disqualifiers: Diabetes, Hypertension, Organ disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications that can affect weight, such as steroids, beta-blockers, and antipsychotics. If you are on these medications, you may need to stop them to participate.

What data supports the effectiveness of the overfeeding treatment for obesity?

The research shows that overfeeding leads to weight gain and changes in body composition, which can help identify individuals' susceptibility to obesity. This suggests that overfeeding might be used to study and understand obesity better, although it is not a direct treatment for reducing obesity. ^{1 2 3 4 5}

Is overfeeding generally safe for humans?

Overfeeding can lead to weight gain, changes in hormone levels, and increased body dissatisfaction, but most effects return to normal after stopping overfeeding. However, body dissatisfaction may persist, so it's important to consider mental health support during and after such studies. ^{1 2 3 4 6}

How does the overfeeding treatment for obesity differ from other treatments?

The overfeeding treatment for obesity is unique because it involves intentionally consuming more calories than needed to study the body's response to excess energy intake, which is different from typical weight loss treatments that focus on reducing calorie intake. This approach helps researchers understand genetic and metabolic factors that contribute to obesity, rather than directly treating the condition. ^{1 3 4 6 7}

Research Team

Ursula White, Ph.D.

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

This trial is for men and pre-menopausal women aged 18-42 with a BMI of 25-30, willing to follow study procedures, maintain physical activity levels, drink labeled water for research, and use contraception if necessary. Excluded are those pregnant or planning pregnancy soon, with diabetes or high fasting blood glucose, high blood pressure, eating disorders, certain medication usage including weight loss drugs or antidepressants less than 3 months old.

Inclusion Criteria

I agree to use effective birth control or practice abstinence during the study.

Agree to maintain the same level of physical activity throughout the duration of the study

I am a man or a pre-menopausal woman aged 18-42.

Exclusion Criteria

I regularly use weight loss medications that could affect the study.

You have been diagnosed with a mental condition that causes you to lose touch with reality.

I am not on long-term medications that significantly affect my weight.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo overfeeding with a 30% increase in caloric intake to study adipose tissue expansion and remodeling

8 weeks

Follow-up

Participants are monitored for changes in adipose tissue and cardiometabolic health outcomes after the treatment phase

4 weeks

Treatment Details

Interventions

• Control (Behavioral Intervention)
• Overfeeding (Behavioral Intervention)

Trial Overview The study tests how short-term weight gain affects the ability of subcutaneous fat tissue to expand and remodel. Participants will be randomly assigned to either continue their normal diet (control group) or increase their calorie intake by 30% (overfeeding group), examining impacts on metabolic health outcomes.

Participant Groups

Group I: Overfeeding Experimental Treatment 1 Intervention

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.

Group II: Control Experimental Treatment 1 Intervention

The control group will be expected to maintain their weight within 1 kg of baseline weight throughout the duration of the study.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Pennington Biomedical Research Center Baton Rouge, LA

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Patients Recruited

183,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2513

Patients Recruited

4,366,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biology of human overfeeding: A systematic review. Bray, GA., Bouchard, C.[2021]

The study involved 8 overweight/obese participants and assessed the reproducibility of their energy intake after consuming a liquid preload, showing that ad libitum energy intake was highly reproducible with an intraclass correlation of 0.97 for control preloads.

Participants consumed more energy after a control preload compared to a whey protein preload, indicating that the type of preload can influence subsequent food intake, but overall energy intake remained consistent across repeated trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is ad libitum energy intake in overweight subjects reproducible in laboratory studies using the preload paradigm? Lara, J., Taylor, MA., Macdonald, IA.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-protein overfeeding: a tool to unmask susceptibility to obesity in humans. Dulloo, AG., Jacquet, J.[2019]

In two studies involving a total of 60 participants over 8 weeks of controlled overfeeding, hunger and food cravings decreased, while depressive symptoms and fear of fatness increased, indicating psychological impacts of overfeeding.

Body dissatisfaction rose during the overfeeding period and persisted for up to three months after, suggesting that even temporary weight gain can have lasting effects on body image, highlighting the importance of addressing these issues in individuals who experience weight fluctuations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 8 weeks of supervised overfeeding on eating attitudes and behaviors, eating disorder symptoms, and body image: Results from the PROOF and EAT studies. Höchsmann, C., Fearnbach, N., Dorling, JL., et al.[2022]

After weight loss, individuals who were previously obese required significantly fewer calories (about 28% less) to maintain their new weight compared to their previous obese state, indicating a metabolic adaptation.

Despite still weighing significantly more than individuals who have never been obese, the reduced-obese patients needed to consume fewer calories than expected based on their body size, suggesting that long-term weight maintenance may require stricter dietary restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diminished energy requirements in reduced-obese patients. Leibel, RL., Hirsch, J.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant gastrostomy and chronic formula infusion as a technique to overfeed and accelerate weight gain of neonatal rats. West, DB., Diaz, J., Woods, SC.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of candidate genes in the responses to long-term overfeeding: review of findings. Ukkola, O., Bouchard, C.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

The biology of human overfeeding: A systematic review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Is ad libitum energy intake in overweight subjects reproducible in laboratory studies using the preload paradigm? [2015]

3. England pubmed.ncbi.nlm.nih.gov

Low-protein overfeeding: a tool to unmask susceptibility to obesity in humans. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of 8 weeks of supervised overfeeding on eating attitudes and behaviors, eating disorder symptoms, and body image: Results from the PROOF and EAT studies. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Diminished energy requirements in reduced-obese patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Infant gastrostomy and chronic formula infusion as a technique to overfeed and accelerate weight gain of neonatal rats. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Role of candidate genes in the responses to long-term overfeeding: review of findings. [2019]