Effects of Hormonal STatus on Energy Expenditure and Feeding behAvior in woMen(ESTEAM)

What this trial studies

The health of women throughout their lives and especially during aging is a subject at the heart of current health issues. Indeed, hormonal variations during a woman's life condition her reproductive life, but also her cardiometabolic health (insulin sensitivity, lipid and inflammatory profile), musculoskeletal health and the maintenance of her mobility. The changes in body composition that occur with age, but also according to hormonal status (Isacco et al. 2021), as well as the metabolic impact of menopause are mechanisms favoring weight gain and more specifically fat mass (Leeners et al 2017).

Conditions in scope

• Energy Expenditure, Appetite, Energy Intake, Food Reward Menopause Transition

Interventions

• Walk test and meal test (Behavioral) — The subjects will perform a treadmill walking test at increasing speed from 2 to 6km.h-1 in 5min increments. During the second experimental visit, subjects will be required to consume a test meal containing 590kcal (12% protein, 35% fat, 53% carbohydrate)…

Who can join

Women only · Ages 18 Years and up · Accepts healthy volunteers.

Inclusion criteria

• Adult female volunteer
• Body mass index \> 18.5 kg/m2 and ≤35 kg/m2
• Able to provide informed consent to participate in research
• Subject to a Social Security scheme.
• Pre-menopausal woman with or without oral contraception and having regular menstrual cycles (21-35 days) or
• Perimenopausal woman: presence of irregularity in the menstrual cycles (\>7 days) and/or amenorrhea ≥2 and 12 months or
• Postmenopausal woman: amenorrhea (absence of menstruation) for at least one year and for a maximum of 10 years, and menopause having appeared after 40 years.

Exclusion criteria

• Chronic illness or a long-term condition, being under medical treatment
• Pregnant or breastfeeding women.
• Women on contraceptives other than oral contraceptives
• Postmenopausal women undergoing hormonal treatment for menopause
• Cardiorespiratory and/or osteo-articular disorders limiting their ability to perform the walk test
• Type 1 diabetes or type 2 diabetes treated with medication
• Progressive cardiovascular or neoplastic disease.
• Major infection in the 3 months preceding inclusion.

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: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2024-01-05
• Primary completion: 2025-03-15
• Last update posted: 2025-06-05
• First posted: 2023-07-07

Sponsor & contact

Lead sponsor: University Hospital, Clermont-Ferrand (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 (Resting energy expenditure and EE during the walk test will be assessed during the first experimental day. Thermic effect of food will be investigated during the second experimental day.)
  Resting energy expenditure will be calculated, on an empty stomach, for 30 minutes using the indirect calorimetry method. Energy expenditure will be assessed during walking exercise by portable indirect calorimetry (MetaMax, Inc.) through the measurement of gas exchange. Indirect calorimetry is one of the classic methods of measuring energy expenditure during exercise. After the test meal, energy expenditure will be…

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.