Thermogenenic Responses to Fasting and Overfeeding in Women
Recruiting · NCT06610162 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- for premenopausal women
- Age 18-45 years.
- Regular menses (no missed cycles in the previous year; cycle length 25-35 d).
- Inclusion criteria for postmenopausal women
- 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.
Where it is running
1 location listed across 1 US state.
- University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States