Effects of Hormonal STatus on Energy Expenditure and Feeding behAvior in woMen(ESTEAM)
ESTEAM
ESTEAM
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
66
1 country
1
Study Start
January 5, 2024
Actual (reported)Primary Completion
March 15, 2025
Actual (reported)Study Completion
March 15, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 15, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 29, 2023
Actual (reported)July 7, 2023
Actual (reported)January 5, 2024
Actual (reported)March 15, 2025
Actual (reported)March 15, 2025
Actual (reported)Energy expenditure
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 evaluated in the postprandial period by indirect calorimetry for 180 min (MétaMax, Inc.). During the measurement, the subject will be seated comfortably in an armchair and will be offered the opportunity to view a calm film/documentary throughout the measurement in order to limit boredom.
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.
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) (Duhita et al 2017). The composition of the test meal will be developed based on the food preferences and habits questionnaires completed during the inclusion visit. Foods indicated as "preferred" by participants will not be offered during these sessions to avoid any influence of their palatable nature on participants' consumption.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Martine Duclos
University Hospital, Clermont-Ferrand
66 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2023
First Posted
July 7, 2023
Study Start
January 5, 2024
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 15, 2025
Actual (reported)Study Completion
March 15, 2025
Actual (reported)Last Updated
June 5, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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