NCT06610162Recruiting
Thermogenenic Responses to Fasting and Overfeeding in Women
Thermogenic Responses to Fasting and Overfeeding in Women: a Potential Mechanism Contributing to Postmenopausal Weight Gain
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study plans to learn more about why menopause increases the risk of weight gain. During and after menopause, women are prone to increased weight gain. The weight gained is primarily body fat, particularly visceral or abdominal body fat. The excess gain in abdominal fat during menopause increases the risk of chronic metabolic diseases such as heart disease and diabetes. The increase in weight and body fat with menopause may be due to changes in metabolism related to the loss of estrogen. This study plans to compare how the metabolism of premenopausal and postmenopausal women responds to changes in energy intake. The investigators will compare the changes in energy expenditure that occur during a period of acute fasting (24 hours) and a period of consuming excess calories (overfeeding).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 18 Sept 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Obesity
- NCT number
- NCT06610162
What you commit to
- Study type: Interventional
- Planned participants: 56
- From 1 Jan 2025 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Age 18-45 years.
- Regular menses (no missed cycles in the previous year; cycle length 25-35 d).
- No menses for at least 12 months
- Follicular stimulating hormone (FSH) ≥50 mIU/ml.
- Women who are within 2 years of the final menstrual period are preferred
- The primary exclusion criteria are:
- Body mass index \> 30 kg/m2
- Diabetes (fasting glucose \>126 mg/dL).
- Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) \<0.5 or \>5.0 mU/L
- Uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP \>90 mmHg.
- Additional exclusion criteria for postmenopausal women
- History or current use of estrogen-based hormonal therapy
- Women who have undergone surgical menopause.
- Additional exclusion criteria for premenopausal women
- Current hormonal contraceptive use (past 6 mo.).
- Pregnant, lactating, or intention to become pregnant during the study period.
- Participants who fail the thyroid and BP criteria will be considered for enrollment if they receive treatment for these conditions and are considered stable by their treating physician.
Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.