Thermogenenic Responses to Fasting and Overfeeding in Women

What this trial studies

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.

Conditions in scope

• Obesity

Interventions

• Eucalaloric feeding (Other) — Participants will complete a 3-day diet run-in followed by an 24-hr in-patient visit in the room calorimeter. The energy content of the diet will be REE x 1.5 (30% fat, 55% carbohydrate, 15% protein). On the study day, will arrive…
• Acute Fasting (Other) — Participants will complete a 3d diet run-in followed by an 24h in-patient visit in the room calorimeter. The energy content of the diet will be REE x 1.5 (30% fat, 55% carbohydrate, 15% protein). On the study day, will arrive…
• Acute Overfeeding (Other) — Participants will complete a 3d diet run-in followed by an 24h in-patient visit in the room calorimeter. The energy content of the diet will be REE x 1.5 (30% fat, 55% carbohydrate, 15% protein). On the study day, will arrive…

Who can join

Women only · Ages 18 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• 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

Exclusion criteria

• 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.
• History or current use of estrogen-based hormonal therapy
• Women who have undergone surgical menopause.
• Current hormonal contraceptive use (past 6 mo.).
• Pregnant, lactating, or intention to become pregnant during the study period.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-01-01
• Primary completion: 2029-12-31
• Last update posted: 2025-04-30
• First posted: 2024-09-24

Sponsor & contact

Lead sponsor: University of Colorado, Denver (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Energy expenditure (24 hours)
  The number of calories burned over a set period of time

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.