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NCT Number: NCT07021664

Health, Imaging, and Cognition Across the Menopausal Transition

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.

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Key information

Conditions

Menopause Acid-Base Imbalance Acidosis Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre de recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location contact

Melanie Fortier, M.Sc.

CONTACT

[email protected]

8195758134

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. cerebral metabolic rates (μmol/100 g/min) measured by PET (11C-AcAc +18F-FDG)

    Time frame: 1 day at baseline

    Brain energy metabolism will be quantified using two PET tracers: 11C-acetoacetate (for ketone use) and 18F-fluorodeoxyglucose (for glucose use). This will allow comparison of brain fuel usage between three menopausal groups (PRE, PERI, POST).Total Cerebral metabolic rates (μmol/100 g/min) (CMR tot= CMR acac + CMRglu)

  2. Tracer influx rates (k) measured by PET (11C-AcAc +18F-FDG)

    Time frame: 1 day at baseline

    Brain energy metabolism will be quantified using two PET tracers: 11C-acetoacetate (for ketone use) and 18F-fluorodeoxyglucose (for glucose use). This will allow comparison of brain fuel usage between three menopausal groups (PRE, PERI, POST). tracer influx rates (K values).

Secondary outcomes

  1. Time-activity curves of the estrogen receptor in the brain (by 18F-4FMFES PET)

    Time frame: 1 day at baseline

    Time-activity curves of the estrogen recept will be measured using 18F-4FMFES PET express as SUV (Standardized Uptake Value)

  2. distribution volume ratio of the estrogen receptor in the brain (by 18F-4FMFES PET)

    Time frame: 1 day at baseline

    distribution volume ratio of the estrogen receptor will be measured by kinetic modelisation using 18F-4FMFES PET.

  3. Glucose variability (SD of glucose measured by continuous glucose monitoring)

    Time frame: Over 5 days following sensor placement et stabilisation

    Continuous glucose monitoring (CGM) will track glucose levels over several days. Glycemic variability will be assessed by the standard deviation of glucose values over the 5 days monitoring period. (mmol/L)

  4. Glucose average (mean of glucose measured by continuous glucose monitoring)

    Time frame: Over 5 days following sensor placement et stabilisation

    Continuous glucose monitoring (CGM) will track glucose levels over several days. Average glucose concentration over the monitoring period.(mmol/L)

  5. Time in range

    Time frame: Over 5 days following sensor placement et stabilisation

    Total minutes with glucose values within the standard glycemic range (3.9-10.0 mmol/L) over the 5 days monitoring period. (min)

Other outcomes

  1. Brain volume

    Time frame: 1 day at baseline

    Will be measured by MRI - T1-weighted images and express in cm³

  2. Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: 1 day at baseline

    Assesses verbal memory. Total score (range: 0-75); higher scores indicate better performance

  3. Stroop Color and Word test (Stroop Test) (secondes)

    Time frame: 1 day at baseline

    Measures processing speed and executive function; outcome is time to completion.

    Unit of Measure: Seconds; lower scores indicate better performance

  4. Trail making test (secondes)

    Time frame: 1 day at baseline

    Assesses cognitive flexibility, visual attention, and processing speed. Unit of Measure: Seconds; lower scores indicate better performance

  5. Montreal Cognitive Assessment (MoCA) score

    Time frame: 1 day at baseline

    Global cognitive screening tool. Unit of Measure: Score (range: 0-30); higher scores indicate better cognition.

  6. Boston naming tests (total answer)

    Time frame: 1 day at baseline

    Measures language and word retrieval ability.Total correct responses (range: 0-60); higher scores are better

  7. Symbol coding (score)

    Time frame: 1 day at baseline

    Assesses processing speed.Score (higher = better)

  8. Logical Memory Subtest of the Wechsler Memory Scale-IV

    Time frame: 1 day at baseline

    Assesses elayed story recall. Score (0-25); higher scores indicate better memory

  9. Fasting plasma glucose (mM)

    Time frame: 1 day at baseline

    Blood samples will be used to assess the systemic metabolis plasma markers and will be compared across 3 groups

  10. Fasting plasma insulin (mM)

    Time frame: 1 day at baseline

    Blood samples will be used to assess the systemic metabolis plasma markers and will be compared across 3 groups

  11. Fasting plasma HbA1c (%)

    Time frame: 1 day at baseline

    Blood samples will be used to assess the systemic metabolis plasma markers and will be compared across 3 groups

  12. Fasting plasma total ketone (uM)

    Time frame: 1 day at baseline

    Blood samples will be used to assess the systemic metabolis plasma markers and will be compared across 3 groups. Total ketone = acetoacetate + beta-hydroxybutyrate

  13. Estrogene levels (pmol/L)

    Time frame: 1 day at baseline

    Blood samples will be used to assess sex hormone and will be compared across 3 group

  14. follicule stimulating hormone levels (mIU/mL)

    Time frame: 1 day at baseline

    Blood samples will be used to assess sex hormone and will be compared across 3 group

  15. Progesterone (nmol/L)

    Time frame: 1 day at baseline

    Blood samples will be used to assess sex hormone and will be compared across 3 group

  16. hormone lutéinisante (mUI/mL)

    Time frame: 1 day at baseline

    Blood samples will be used to assess sex hormone and will be compared across 3 group

  17. Menopause-Specific Quality of Life Questionnaire

    Time frame: 1 day at baseline

    Self-reported questionnaires. Self-reported symptom burden. Unit of Measure: Score (range: 0-44); higher = more severe symptoms

  18. Menopause Rating Scale

    Time frame: 1 day at baseline

    Self-reported symptom burden. Unit of Measure: Score (range: 0-44); higher = more severe symptoms

  19. Pittsburgh Sleep Quality Index

    Time frame: 1 day at baseline

    Self-reported questionnaire. Assesses sleep quality over the past month. Unit of Measure: Score (range: 0-21); higher = poorer sleep

  20. Patient Health Questionnaire (PHQ-9)

    Time frame: 1 day at baseline

    Depressive symptoms. Score (range: 0-27); higher = more severe depression

  21. Subjective memory complain

    Time frame: 1 day at baseline

    Self-reported memory or concentration issues. Unit of Measure: Score (range 62-372) ; higher scores indicate more complaints

  22. International Physical Activity Questionnaire

    Time frame: 1 day at baseline

    Physical activity over the past week. (MET-minutes/week)

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Fortier, M.Sc.

CONTACT

[email protected]

1-819-821-5206

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Nestlé Health Science

Registry information

Official study title

Santé, Imagerie et Cognition à Travers la Transition ménopausique

Acronym: MOSAIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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