Clinical trial NCT05935046: Effects of Hormonal STatus on Energy Expenditure and Feeding behAvior in woMen(ESTEAM)
Official title: Effects of Hormonal STatus on Energy Expenditure and Feeding behAvior in woMen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Expenditure, Appetite, Energy Intake, Food Reward Menopause Transition
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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). The decrease in estrogen levels during the transition to menopause seems to be the main factor explaining the increase in adiposity, especially visceral, and a decrease in muscle capital. Indeed, estrogens participate in the structural remodeling of muscle tissue as well as in maintaining its oxidative potential (Sutham et al 2018). However, the mechanisms promoting changes in body composition during the transition to menopause remain poorly understood. Better characterizing the energy profile (energy expenditure) and the food profile with regard to body composition in non- and postmenopausal women would make it possible to better target the recommendations for the primary prevention of cardiometabolic alterations linked to ovarian aging.


Eligibility criteria: 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.
* Known neuromuscular pathology: myopathy, myasthenia, rhabdomyolysis, paraplegia, hemiplegia,
* Chronic or acute inflammatory disease in the 3 months preceding inclusion
* Treatment with beta-blocker
* Diagnosis or treatment for schizophrenia, bipolar disorder, major depression
* Discontinuation of treatment for less than 3 months prior to inclusion, with corticosteroids, immunosuppressant, anabolic, growth hormone.
* Eating behavior disorders
* Amenorrhea linked to a pathology or its treatment (pituitary tumour, radiotherapy, chemotherapy, oophorectomy, etc.)
* Unstable psychiatric state
* Significant alcohol consumption (\> 2 to 3 drinks per day depending on gender) or the presence of drug addiction.
* Inability to walk for 30 minutes at a time
* Subject in a period of exclusion from another study or having received more than €4,500 in the year following their participation in clinical studies.
* Deprivation of liberty by judicial or administrative decision (guardianship, curatorship or safeguard of justice).
* Refusal to sign the written consent to participate.
* Participation in another study in the previous 6 months

Primary outcomes:
measure: Energy expenditure
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine Duclos
role: PRINCIPAL_INVESTIGATOR
References: