Recruiting

Menopausal Transition

Sponsor:

Université de Sherbrooke

Code:

NCT07021664

Conditions

Menopause

Eligibility Criteria

Sex: Female

Age: 35 - 65

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This observational cross-sectional study aims to better understand how the menopausal transition affects brain energy metabolism and cognition. Menopause, a natural stage in a woman's life, is typically divided into three phases: premenopause, perimenopause, and postmenopause. This transition involves hormonal fluctuations and a decline in estrogen levels, which can impact physical, emotional, and cognitive well-being. Common symptoms include hot flashes, sleep disturbances, mood changes, and difficulties with memory and concentration.

Emerging evidence suggests that the decline in estrogen may impair how the brain uses glucose, its primary energy source. This reduction in glucose metabolism is thought to contribute to cognitive difficulties reported during midlife. In contrast, the brain's capacity to use ketones-alternative energy substrates produced during fasting or low-carbohydrate intake-appears preserved during aging and hormonal changes. Increasing circulating ketones may offer a promising strategy to support brain energy and cognitive function.

To explore these relationships, the study will employ advanced brain imaging (PET scans) to assess glucose and ketone uptake in the brain. Additional measures will include hormone levels, cognitive testing, continuous glucose monitoring, and MRI. PET tracers will also be used to evaluate estrogen receptor distribution, providing insight into how the brain responds to hormonal changes.

A total of 45 women aged 35-60 will be enrolled and categorized into three groups (15 per group): premenopause, perimenopause, and postmenopause. Each participant will attend four study visits that include questionnaires, blood tests, cognitive assessments, metabolic measurements, and imaging procedures.

The results may help identify early neurobiological and metabolic markers associated with the menopausal transition. These findings could inform new approaches to preserve brain health and prevent cognitive decline in aging women. Improving understanding of how the female brain adapts to hormonal shifts may ultimately support more targeted strategies for promoting healthy aging.

Conditions

Menopause

Study ID

NCT07021664

Start date

Jul 1, 2025

Status verified date

Sep, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able to read and speak French
  • Capable of understanding and signing informed consent GROUP SPECIFIC INCLUSION CRITERIA Premenopause: • Women aged 35 to 55; No change in menstrual cycle regularity over the past 10 months (variation less than 7 days per cycle)

Perimenopause: Women aged 40 to 60; Menstrual cycles varying by more than 7 days per cycle for at least 10 cycles, or no period for 3 to 11 months

postmenopause: Women aged 45 to 65; No menstrual period for ≥ 12 months

Exclusion Criteria:

  • Pregnancy, childbirth within the past 12 months, or breastfeeding
  • Use of hormone replacement therapy or hormonal contraceptives in the past 6 months
  • contraindications to MRI (e.g., presence of non-compatible metallic objects)
  • Claustrophobia
  • Type 1 diabetes
  • Adherence to a ketogenic intervention (e.g., ketone supplements, intermittent fasting, ketogenic diet) in the past 3 months
  • Engaging in intense physical activity 5 times per week or more
  • Any significant neurological disorder (e.g., dementia, brain tumor, seizure disorder, history of significant head trauma with persistent neurological deficits, known structural brain abnormalities)
  • History of oophorectomy or hysterectomy
  • Any significant psychiatric disorder (e.g., major depression within the past 2 years, bipolar disorder, schizophrenia)
  • Systemic diseases or unstable/uncontrolled medical conditions (e.g., cardiovascular disease, uncontrolled diabetes, kidney or liver disorders)
  • Any other condition that may interfere with participation, as judged by the study physician

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

premenopause

Women between 35 and 55 years old who still have regular menstrual cycles, with no noticeable changes in the past 10 months.

perimenopause

Women between 40 and 60 years old who have experienced changes in their menstrual cycles, such as irregular timing (varying by more than 7 days) for at least 10 cycles, or no period for 3 to 11 months.

postmenopause

Women between 45 and 65 years old who have not had a menstrual period for 12 months or more.

Primary outcome measure

  • cerebral metabolic rates (μmol/100 g/min) measured by PET (11C-AcAc +18F-FDG) [ Time Frame: 1 day at baseline ]
  • Tracer influx rates (k) measured by PET (11C-AcAc +18F-FDG) [ Time Frame: 1 day at baseline ]

Central Contacts and Locations

Central contacts

Melanie Fortier, M.Sc.

1-819-821-5206recherche.cerveau@usherbrooke.ca

Locations

Research Center on Aging

Recruiting

Sherbrooke, Quebec, Canada, J1H2J7

Contacts

Mélanie Fortier

819-780-2220Melanie.Fortier2@USherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Oct 26, 2026

Last verified

Sep, 2026

Keywords

  • menopause
  • cognition
  • metabolism
  • estrogen
  • ketone
  • PET scan
  • estrogen receptor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.