NCT06610162 Thermogenenic Responses to Fasting and Overfeeding in Women
| NCT ID | NCT06610162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2025-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06610162 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06610162 currently recruiting?
Yes, NCT06610162 is actively recruiting participants. Contact the research team at ed.melanson@cuanschutz.edu for enrollment information.
Where is the NCT06610162 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06610162 clinical trial?
NCT06610162 is sponsored by University of Colorado, Denver. The trial plans to enroll 56 participants.
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