Obesity Trial, Recruiting NCT04293224 Sponsor: USDA, Western Human Nutrition Research Center Condition: Obesity
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Obesity Trial, Recruiting

NCT04293224
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People with a Body Mass Index (BMI) between 23 and 39.9, or a body fat percentage between 32% and 50%.
  • People who are willing to have blood drawn as part of the study.
  • People who also have at least one of the following: a fasting blood sugar level between 100 and 125 mg/dL; fasting triglycerides (a type of blood fat) of 125 mg/dL or higher; HDL ("good") cholesterol of 50 mg/dL or lower; a systolic (top number) blood pressure of 130 mmHg or higher, or diastolic (bottom number) blood pressure of 85 mmHg or higher; or a HbA1c (a measure of average blood sugar) between 5.7% and 6.4%.

Who may not be able to join:

  • People who are currently taking part in another research study.
  • People who have tested positive for COVID-19 in the past 10 days.
  • People who have been in close contact with someone who had COVID-19 in the past 14 days.
  • People with a systolic (top number) blood pressure of 140 mmHg or higher, or a diastolic (bottom number) blood pressure of 90 mmHg or higher.
  • People with LDL ("bad") cholesterol of 190 mg/dL or higher.
  • People with triglycerides (a type of blood fat) of 500 mg/dL or higher.
  • People who have used tobacco products, e-cigarettes, vaping products, cannabis, or any other nicotine-containing product in the past 6 months.
  • People who are currently taking dietary supplements or who are not willing to stop taking them during the study.
  • People who follow a vegan or vegetarian diet, or who have any other dietary restrictions, food intolerances, allergies, or sensitivities that would prevent them from eating or drinking the study foods and beverages.
  • People who are unwilling to consume the specific foods and beverages provided as part of the study.
  • People who drink more than one alcoholic drink per day on a regular basis, or who engage in binge drinking (4 or more drinks within two hours).
  • People who are unwilling to avoid alcohol for specific periods required by the study.
  • People who consume 400 mg or more of caffeine per day (considered excessive for this study).
  • People who are unwilling to avoid caffeine on the days they visit the lab.
  • People who have intentionally lost or gained 5% or more of their body weight in the 6 months before joining the study.
  • People who have been diagnosed with a disordered eating pattern or an eating disorder.
  • People recently diagnosed with, or whose screening blood tests show, anaemia (low haemoglobin), or abnormal liver or thyroid function (confirm with trial site for specific values).
  • People with a history of gastric bypass surgery, inflammatory bowel disease (IBD), or other gut conditions that would prevent them from consuming the study foods.
  • People with a history of active cancer in the past three years, with the exception of certain minor skin cancers that have been treated by local removal.
  • People with recent dental work or mouth conditions that would prevent them from eating or drinking the study foods and beverages.
  • People currently taking antipsychotic medications.
  • People who have been on long-term antibiotic treatment.
  • People currently taking any prescription or over-the-counter medication for high cholesterol, high blood sugar, high blood pressure, weight loss, or conditions that require corticosteroid medicines (such as asthma, arthritis, or eczema).
  • People who are pregnant, planning to become pregnant during the study period, or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Kevin D Laugero, PhD, USDA, Western Human Nutrition Research Center

Phone: 530-754-2541

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
USDA, Western Human Nutrition Research Center
Registry
ClinicalTrials.gov
Start date
1 August 2022
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in body weight

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov