Effects of fasting and overfeeding on metabolism in women
Official title: Thermogenic Responses to Fasting and Overfeeding in Women: a Potential Mechanism Contributing to Postmenopausal Weight Gain
Run by University of Colorado, Denver · NCT06610162 · Data updated 2026-11-12
This study tests how fasting and overeating affect metabolism in premenopausal and postmenopausal women to see how menopause influences weight gain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 56 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | cart |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT06610162 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include premenopausal women aged 18-45 with regular menstrual cycles and postmenopausal women who have not menstruated for at least 12 months.
✕Probably not a fit
Patients with a body mass index over 30 kg/m2, diabetes, or those on estrogen-based hormonal therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to investigate how menopause affects weight gain by comparing the metabolic responses of premenopausal and postmenopausal women to fasting and overfeeding. Participants will undergo three conditions: eucaloric feeding, acute fasting for 24 hours, and acute overfeeding with a low-protein diet. The study will measure energy expenditure and its components using a calorimeter to understand the metabolic changes associated with menopause. The research seeks to clarify the relationship between hormonal changes and energy metabolism during this life stage.
Why it matters
Potential benefit: If successful, this study could provide insights into managing weight gain and metabolic health in menopausal women.
How similar studies have gone: Other studies have explored metabolic responses to dietary changes, but this specific comparison of fasting and overfeeding in relation to menopause is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States Recruiting
Study contacts
- Study coordinator: Edward L Melanson, PhD
- Email: ed.melanson@cuanschutz.edu
- Phone: 303-724-0935
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.