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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • CHU clermont-ferrand

    Clermont-Ferrand

    Lise LACLAUTRE, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    martine DUCLOS

    Recruiting

Other trials in France

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 groups in NCT05944653
Study groupRoleWhat they receive
Women with hormonal contraceptionNot described
Women without hormonal contraceptionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted13 Jul 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionSep 2023 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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)
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

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.

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