Thermogenenic Responses to Fasting and Overfeeding in Women

NCT06610162 | Recruiting

• 1 other identifier: 24-1819
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity

Keywords

energy expenditure; adaptive thermogenesis; menopause

Outcome Measures

Primary Outcomes (1)

• Energy expenditure

  The number of calories burned over a set period of time

  24 hours

Secondary Outcomes (4)

• Fibroblast growth factor 21 (FGF21)

  24 hours

• 24 hour carbohydrate oxidation

  24 hours

• 24 hour fat oxidation

  24 hours

• 24 hour protein oxidation

  24 hours

Study Arms (2)

Premenopausal women

OTHER

Other: Eucalaloric feeding; Other: Acute Fasting; Other: Acute Overfeeding

Postmenopausal women

OTHER

Other: Eucalaloric feeding; Other: Acute Fasting; Other: Acute Overfeeding

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.

Postmenopausal women; Premenopausal women

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.

Postmenopausal women; Premenopausal women

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.

Postmenopausal women; Premenopausal women

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Edward L Melanson, PhD

CONTACT

303-724-0935; ed.melanson@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This cross-sectional study will compare fasting and overfeeding effects on 24-hour EE and its components in pre- and postmenopausal women. We will study participants under three conditions in the room calorimeter: 1) eucaloric feeding (energy intake = EE); 2) acute, 24-hour fasting; and 3) acute, 24-hour overfeeding of a low-protein diet (i.e., 200% of energy requirements). Participants will complete the eucaloric study and then complete the overfeeding and fasting studies in random order. There will be a 1-4-week washout between conditions. Studies in premenopausal women will be performed during the mid-luteal phase (i.e., days 16-24) when both E2 and progesterone are elevated and, thus, when the potential hormonal effects are maximal.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 30, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data that can be shared will be made available at the time of associated publication(s) (data underlying peer-reviewed journal articles). Data that can be shared will be available for three years after completion of the project or after the last relevant publication, whichever is later.
• Access Criteria: We will share data in a generalist repository as controlled access. Our institutional IRB does not allow public (open access) sharing of individual participant data. Only qualified individuals within the scientific community who request access to validate and replicate published research findings or perform analyses aligning with the approved protocol will receive repository access. Data users also agree not to share or redistribute any data downloads. Any publications or presentations that use the shared dataset must appropriately acknowledge the data source, list authors, and cite the associated publications. The requestor\'s institutional IRB or equivalent body must approve the requested use of the data. Data requestors must sign a data transfer agreement outlining the agreement with the above conditions to gain access

Locations

US (1)