Clinical trial

Thermogenenic Responses to Fasting and Overfeeding in Women

Recruiting now · Not applicable · 1 countries · Registry ID NCT06610162

Recruiting nowNot applicableInterventional

What this study 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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexFemale
Healthy volunteersAccepted
ConditionObesity

Full registry 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.

Treatments and study arms

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 at 7 AM and an IV catheter will be placed for blood draws, as described in the research plan. Participants will then enter the calorimeter at 0800, exit at 0700 the following day. Participants will be instructed to engage in primary sedentary behaviors. The energy content of the diet will be 1.3 x REE (\~30% fat, 55% carbohydrate, and 15% protein at each meal). Breakfast will account for \~25% and lunch and dinner \~30-35% of total energy needs. Meals will be provided at 0900, 1300, and 1800, and a light snack will be provided at 2000.

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 at 7 AM and an IV catheter will be placed for blood draws, as described in the research plan. Participants will then enter the calorimeter at 0800, exit at 0700 the following day. Participants will be instructed to engage in primary sedentary behaviors. Participants will complete a 24 hour fast while in the calorimeter. They will be permitted to consume non-caloric beverages (i.e., water, non-caloric and non-caffeinated soft drinks, caffeine-free tea, or decaffeinated coffee) but refrain from consuming any caloric food or beverages. Upon exiting the calorimeter, participants will be provided a meal from the University of Colorado Hospital Patient Kitchen.

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 at 7 AM and an IV catheter will be placed for blood draws, as described in the research plan. Participants will then enter the calorimeter at 0800, exit at 0700 the following day. Participants will be instructed to engage in primary sedentary behaviors. The energy content of the diet will be 200% of energy requirements, based on EE measured during the eucaloric condition. Macronutrient intake will be 3% protein, 51% carbohydrate, and 46% fat. Breakfast will account for \~25% and lunch and dinner \~30-35% of total energy needs. Meals will be provided at 0900, 1300, and 1800, and a light snack will be provided at 2000.

Primary outcomes

Energy expenditure24 hours

The number of calories burned over a set period of time

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States
Edward Melanson, Ph.D.Contact
Edward L Melanson, Ph.D.Principal Investigator