Energy Expenditure, Appetite, Energy Intake, Food Reward Menopause TransitionESTEAMNCT05935046
Effects of Hormonal STatus on Energy Expenditure and Feeding behAvior in woMen(ESTEAM)
A study testing Walk test and meal test in people with Energy Expenditure, Appetite, Energy Intake, Food Reward Menopause Transition, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure, Appetite, Energy Intake, Food Reward Menopause Transition
- What is being tested?
- Walk test and meal test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hormonal STatus on Energy Expenditure and Feeding behAvior in woMen
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.
- Being tested
- Walk test and meal test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk test and meal testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal Status | Experimental | Not described Receives: Behavioral: Walk test and meal test |
| Peri Menopausal status | Experimental | Not described Receives: Behavioral: Walk test and meal test |
| Menopausal status | Experimental | Not described Receives: Behavioral: Walk test and meal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start5 Jan 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy Expenditure, Appetite, Energy Intake, Food Reward Menopause TransitionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935046
- Sponsor's protocol ID
- RBHP 2022 DUCLOS 2
- Other IDs
- 2022-A02464-39
- Acronym
- ESTEAM
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hormonal STatus on Energy Expenditure and Feeding behAvior in woMen
- ClinicalTrials.gov ID
- NCT05935046
- Acronym / sponsor ID
- ESTEAM / RBHP 2022 DUCLOS 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Status | Experimental | Behavioral: Walk test and meal test |
| Peri Menopausal status | Experimental | Behavioral: Walk test and meal test |
| Menopausal status | Experimental | Behavioral: Walk test and meal test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk test and meal testThe 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. | Behavioural | Menopausal status, Peri Menopausal status, Premenopausal Status |
Primary outcome
Energy expenditure
Time frame: 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Duclos principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk test and meal test in people with Energy Expenditure, Appetite, Energy Intake, Food Reward Menopause Transition, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.