Obesity Trial, Recruiting NCT06976112 Sponsor: Pennington Biomedical Research Center Condition: Obesity
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Obesity Trial, Recruiting

NCT06976112
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 who are female
  • People between 40 and 55 years of age
  • People with a BMI (a number based on height and weight) between 28 and 45 kg/m²
  • People who have irregular menstrual cycles but have not gone 12 or more consecutive months without a period
  • People who are experiencing severe hot flashes or night sweats (also called vasomotor symptoms)
  • People who do less than 3 hours per week of structured exercise
  • People whose top blood pressure number (systolic) is between 120 and 140, and/or whose bottom number (diastolic) is between 80 and 90
  • People whose HbA1c (a blood sugar measure) is 6.5% or below
  • People who are willing and able to avoid using mouthwash for the entire duration of the study, as the alcohol in mouthwash interferes with a process the study is measuring
  • People who are willing and able to follow both of the study's eating plans
  • People who are willing to provide blood samples for future research
  • People who can read, speak, and understand English

Who may not be able to join:

  • People who have had their uterus or ovaries removed (fully or partially)
  • People who have used hormone replacement therapy or hormonal contraception within the 6 months before the study starts
  • People whose top blood pressure number is 140 or higher, and/or whose bottom number is 90 or higher
  • People with high triglycerides (350 mg/dL or above), high LDL ("bad") cholesterol (190 mg/dL or above), or who are currently taking cholesterol-lowering medication
  • People who have been diagnosed with heart disease, diabetes (type 1 or 2), a hormonal or glandular condition (such as a thyroid disorder or PCOS), unstable digestive disease, or kidney, liver, or pancreatic disease
  • People who have been diagnosed with cancer (other than skin cancer) in the last 5 years
  • People who are taking more than one blood pressure medication, or who have been taking one blood pressure medication for less than 3 months
  • People who are taking certain medications, including phosphodiesterase-5 inhibitors, blood thinners, corticosteroids, metformin, or insulin (confirm with trial site if unsure which medications apply)
  • People whose weight has changed by 6.6 pounds or more in the past 3 months, who are actively trying to lose weight, or who are unwilling to keep their weight stable during the study
  • People who currently smoke or vape, or who drink heavily or binge drink
  • People who have food allergies or other reasons that would prevent them from eating the foods required in both study diets

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 20 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: Hannah E Cabre, PhD, RDN, Pennington Biomedical Research Center

Phone: 225-763-2826

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
Pennington Biomedical Research Center
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Macrovascular Function; Change in Microvascular Function; Change in Blood Lipids

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: 20 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