Thermogenenic Responses to Fasting and Overfeeding in Women

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06610162
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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 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.

Study Details

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).

Key Dates

Start date
Jan 1, 2025
Status verified
Sep 2024
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Premenopausal women
  • Other: Postmenopausal women

Primary Outcome Measure

Energy expenditure [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Edward Melanson, Ph.D.
[email protected]
303-724-0935
Edward L Melanson, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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