WomenCOCONUTNCT05944653
Physical Activity Level and Hormonal Status on Energy Metabolism and Nutritional Responses
An observational study of Women and Metabolism, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Obesity and its associated cardiometabolic comorbidities are a major health problem and although their prevalence is increasing in both men and women, evidence shows a faster increase in women, especially in those of childbearing age. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women, Metabolism
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2023to Dec 2024
- Phase
- Observational
- 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 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women with or without hormonal contraceptives
Who may be able to join
- Aged between 18 and 44y
- BMI between 18 and 25 kg.m-2
- Subject able to provide informed consent to participate
- Subject with a Social Security
Who cannot join
- Medical or surgical history judged by the investigator to be incompatible with the study
- Presence of comorbidities or pathology that could interfere with the study data
- Women in the process of food restriction or weight loss at the time of inclusion or during the last three months
- Irregular menstrual cycles
- Menstrual cycles < 25 days or greater than 35 days
- Pregnant or lactating women
Show all 10Show fewer
- Per or post menopausal women
- Claustrophobia
- Person in period of exclusion from another study
- Person under guardianship or safeguard of justice; or subject without social security
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise LACLAUTRE, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
martine DUCLOS
About this study
Official title: Effects of the Interaction Between Physical Activity Level and Hormonal Status on Energy Metabolism and Nutritional Responses in Women
Obesity and its associated cardiometabolic comorbidities are a major health problem and although their prevalence is increasing in both men and women, evidence shows a faster increase in women, especially in those of childbearing age. In the scientific literature, cardiometabolic risks in women are often considered at menopause, younger women being considered "preserved" or less at risk than men. However, epidemiological studies show that it is essential to study and take into account these risks well before menopause, in particular in women of childbearing age, for their health but also for the health of future generations, considering the intergenerational cycle of women. However, the majority of studies have many limitations concerning the health of women of childbearing age since, in particular, they do not consider the hormonal and therefore physiological specificities of women. Indeed, the natural hormonal variations associated with the menstrual cycle but also the use of hormonal contraception, containing synthetic hormones, are important physiological modulators of these metabolic and nutritional regulations. Interestingly, in a recent narrative review, the investigators pointed out the little existing and reliable data concerning the effect of using oral contraception on the two sides of the energy balance, namely energy expenditure and energy intake. Also, it remains difficult to fully understand these metabolic and nutritional responses and therefore to optimize, whether in terms of primary or tertiary prevention, the health of women. Women using oral contraceptives activated the same brain pathways in response to food stimuli as women without contraception during the luteal phase, whereas these activations differed with respect to the follicular phase. Interestingly, women with overweight or obesity showed similar effects in terms of weight loss in response to an intervention including calorie restriction, a physical activity program and psychological support in women with and without hormonal contraception. However, while women without hormonal contraception managed to maintain the lost weight, women with contraception had a significant weight gain mainly due to an increase in their food intake. Conversely, in young healthy women following a calorie restriction of 500 kcal per week for one month, women with hormonal contraception showed greater weight loss than those without. Several parameters can potentially explain these differences in results, such as weight status, but also the nature of the intervention (i.e. caloric restriction only vs combined energy restriction and physical activity).
It is indeed recognized that the level of physical activity and sedentary behaviours influence the energy expenditure of rest and exercise and also the control of appetite; the investigators have recently shown that this level of physical activity modifies the cardiometabolic responses following a meal in healthy men. This underlines the importance of considering inter-individual parameters, such as the level of physical activity and sedentary lifestyle as a predominant factor in nutritional and energy regulation at rest and during physical exercise, a key factor in energy regulation. In general, studies in women concerning the parameters of the energy balance are heterogeneous in terms of the characteristics of the population, the methodology used and do not take into account all the metabolic and nutritional responses that make it possible to understand these regulations.
Thus, the main objective of this study is to evaluate the effects of hormonal status (women with and without hormonal contraception) on the fuel utilization during low-intensity physical exercise in women of childbearing age according to their level of physical activity.
- Conditions
- Women, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with hormonal contraception | Not described | |
| Women without hormonal contraception | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory quotient
It is the ratio of carbon dioxide production to oxygen consumption and represents the part of carbohydrate and fat oxidation
Measured: Through the 40 minute walking exercise
Secondary outcomes (1)
Energy expenditure
Oxygen consumption assessed by indirect calorimetry
Measured: Through the 40 minute walking exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
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
- NCT05944653
- Sponsor's protocol ID
- RBHP 2023 DUCLOS
- Other IDs
- 2023-A00685-40
- Acronym
- COCONUT
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Interaction Between Physical Activity Level and Hormonal Status on Energy Metabolism and Nutritional Responses in Women
- ClinicalTrials.gov ID
- NCT05944653
- Acronym / sponsor ID
- COCONUT / RBHP 2023 DUCLOS
- Conditions
- Women, Metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 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.
Obesity and its associated cardiometabolic comorbidities are a major health problem and although their prevalence is increasing in both men and women, evidence shows a faster increase in women, especially in those of childbearing age. In the scientific literature, cardiometabolic risks in women are often considered at menopause, younger women being considered "preserved" or less at risk than men. However, epidemiological studies show that it is essential to study and take into account these risks well before menopause, in particular in women of childbearing age, for their health but also for the health of future generations, considering the intergenerational cycle of women. However, the majority of studies have many limitations concerning the health of women of childbearing age since, in particular, they do not consider the hormonal and therefore physiological specificities of women. Indeed, the natural hormonal variations associated with the menstrual cycle but also the use of hormonal contraception, containing synthetic hormones, are important physiological modulators of these metabolic and nutritional regulations. Interestingly, in a recent narrative review, the investigators pointed out the little existing and reliable data concerning the effect of using oral contraception on the two sides of the energy balance, namely energy expenditure and energy intake. Also, it remains difficult to fully understand these metabolic and nutritional responses and therefore to optimize, whether in terms of primary or tertiary prevention, the health of women. Women using oral contraceptives activated the same brain pathways in response to food stimuli as women without contraception during the luteal phase, whereas these activations differed with respect to the follicular phase. Interestingly, women with overweight or obesity showed similar effects in terms of weight loss in response to an intervention including calorie restriction, a physical activity program and psychological support in women with and without hormonal contraception. However, while women without hormonal contraception managed to maintain the lost weight, women with contraception had a significant weight gain mainly due to an increase in their food intake. Conversely, in young healthy women following a calorie restriction of 500 kcal per week for one month, women with hormonal contraception showed greater weight loss than those without. Several parameters can potentially explain these differences in results, such as weight status, but also the nature of the intervention (i.e. caloric restriction only vs combined energy restriction and physical activity).
It is indeed recognized that the level of physical activity and sedentary behaviours influence the energy expenditure of rest and exercise and also the control of appetite; the investigators have recently shown that this level of physical activity modifies the cardiometabolic responses following a meal in healthy men. This underlines the importance of considering inter-individual parameters, such as the level of physical activity and sedentary lifestyle as a predominant factor in nutritional and energy regulation at rest and during physical exercise, a key factor in energy regulation. In general, studies in women concerning the parameters of the energy balance are heterogeneous in terms of the characteristics of the population, the methodology used and do not take into account all the metabolic and nutritional responses that make it possible to understand these regulations.
Thus, the main objective of this study is to evaluate the effects of hormonal status (women with and without hormonal contraception) on the fuel utilization during low-intensity physical exercise in women of childbearing age according to their level of physical activity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with hormonal contraception | – | – |
| Women without hormonal contraception | – | – |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women with or without hormonal contraceptives
Key inclusion criteria (4 listed)
- Aged between 18 and 44y
- BMI between 18 and 25 kg.m-2
- Subject able to provide informed consent to participate
- Subject with a Social Security
Key exclusion criteria (10 listed)
- Medical or surgical history judged by the investigator to be incompatible with the study
- Presence of comorbidities or pathology that could interfere with the study data
- Women in the process of food restriction or weight loss at the time of inclusion or during the last three months
- Irregular menstrual cycles
- Menstrual cycles < 25 days or greater than 35 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory quotient
Time frame: Through the 40 minute walking exercise
It is the ratio of carbon dioxide production to oxygen consumption and represents the part of carbohydrate and fat oxidation
1 secondary outcome
Energy expenditure
Time frame: Through the 40 minute walking exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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?
An observational study of Women and Metabolism, 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory quotient (time frame: Through the 40 minute walking exercise). 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 13 Jul 2023.