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Thermogenenic Responses to Fasting and Overfeeding in Women

Thermogenic Responses to Fasting and Overfeeding in Women: a Potential Mechanism Contributing to Postmenopausal Weight Gain

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 3 days
  • Procedures mentioned: X-rays, CT scans, Blood draws, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "For 3 days before each condition, the investigators will provide participants with an outpatient diet designed to meet free-living energy requirements (energy intake = 1.5 x REE) and stabilize macronutrient intake (15% protein, 30% fat, 55% carbohydrate)."
  • "Body composition - Body composition will be measured using dual X-ray absorptiometry (DXA, Hologic Discovery, Waltham, MA). 3."
  • "Visceral adipose tissue (VAT) volume - VAT volume and subcutaneous fat area (SFA) will be measured using computed tomography (CT)."
  • "Room calorimeter - 24-hour EE and substrate oxidation will be measured using whole-room indirect calorimetry.For three days before each calorimeter study, participants will be instructed to refrain from exercise and provided with all food to stabilize energy and macronutrient intake."
  • "Fasting blood samples will be obtained before breakfast and at the end of the 24-hour study and analyzed for leptin, FGF21, and thyroid hormones (TSH, total T3, free T4)."
  • "Participants will record their time in bed during the first visit and be instructed to prepare for bed during the subsequent two visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

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