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Not yet recruitingNCT07878741EXISOUpdated Oct 16, 2026

The Effects of Menopausal Status, Isoflavone Supplementation and Training on Cardiometabolic Function Women

An interventional study of Red Clover Isoflavone Supplementation and Supervised exercise training in Menopause, Exercise Adaptation and Mitochondrial Alteration, sponsored by University of Copenhagen. Not yet recruiting at 2 sites in Denmark. Open to female participants aged 45 Years to 61 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 61 Years
Sex
Female
01

Study summary

The goal of this clinical trial is to investigate the role of estrogen and isoflavone supplementation in exercise-induced cellular signaling and cardiometabolic adaptations in premenopausal and postmenopausal women. The study will evaluate vascular function, mitochondrial function, acute and long-term exercise responsiveness, and menopause-related outcomes.

The main questions it aims to answer are:

  • Does menopause alter acute exercise-induced activation of cardiometabolic signaling pathways and vascular function?
  • Does isoflavone supplementation enhance exercise-induced improvements in vascular and mitochondrial function in postmenopausal women?
  • Are training-induced adaptations in vascular and mitochondrial function different between premenopausal and postmenopausal women?

Researchers will compare postmenopausal women receiving isoflavone supplementation with postmenopausal women receiving placebo to determine the specific effects of isoflavones. Premenopausal women will serve as a reference group to evaluate menopause-related differences.

Participants will:

  • Complete an 8-week supervised exercise training intervention consisting of three training sessions per week.
  • Undergo assessments of vascular function, including flow-mediated dilation (FMD) and intra-arterial infusions of acetylcholine, epoprostenol, and vitamin C.
  • Provide blood and skeletal muscle samples for analyses of cellular signaling pathways, protein expression, and mitochondrial function.
  • Undergo measurements of aerobic capacity, strength and body composition.
  • Complete questionnaires related to menopause-associated symptoms and health outcomes.

Postmenopausal participants will be randomized to receive either isoflavone supplementation or placebo for 4 weeks prior to and throughout the exercise intervention.

02

Conditions studied

  • Menopause
  • Exercise Adaptation
  • Mitochondrial Alteration
  • Vascular Function in Healthy Volunteers

Keywords

  • Menopause
  • Vascular function
  • Mitochondrial function
  • Training adaptations
  • Isoflavones
  • Supplementation
  • Training intervention
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 465 studies on the registry; 63 are open to participants now.

Browse University of Copenhagen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 61 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women aged ≥45 and \<61 years.
  • Either *
  • *Regular menstrual cycles (premenopausal group), or
  • *More than 5 years since the last menstrual period (postmenopausal groups).
  • Body mass index (BMI) between 18 and 35 kg/m².
  • Able to provide informed consent and comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  • Current smoking.
  • Use of menopausal hormone therapy within the previous 12 months.
  • Consumption of isoflavones through diet or supplements within the previous 12 months.
  • Chronic disease or medical condition, including diabetes mellitus, cardiovascular disease, polycystic ovary syndrome (PCOS), or endometriosis.
  • Active cancer or cancer diagnosis within the previous 5 years.
  • Use of medication for hypertension, hypercholesterolemia, diabetes, obesity, or depression.
  • Ovariectomy
  • Highly physically active lifestyle, defined as more than 3 hours per week of structured moderate-to-vigorous exercise during the previous year, including activities such as running, cycling, or high-intensity team sports.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Premenopausal women

    Premenopausal women that will undergo 8 weeks of training (3 times per week). Work as a reference group for the study.

    Behavioral: Supervised exercise training

  • Placebo comparator
    Postmenopausal women (placebo)

    Postmenopausal women who was randomly allocated to placebo supplementation. Work as control group in the study. They will receive placebo for 4 weeks, and then continue on placebo+training for 8 weeks.

    Behavioral: Supervised exercise training · Dietary Supplement: Placebo Supplementation

  • Experimental
    Postmenopausal women (isoflavones)

    Postmenopausal women who was randomly allocated to isoflavone supplementation. They will receive placebo for 4 weeks, and then continue on isoflavone+training for 8 weeks.

    Dietary Supplement: Red Clover Isoflavone Supplementation · Behavioral: Supervised exercise training

Interventions

  • Dietary supplementRed Clover Isoflavone Supplementation

    Participants will consume 120 mL/day of red-clover-derived isoflavone supplement, for 4 weeks prior to and throughout an 8-week supervised exercise training intervention (total duration: 12 weeks).

    Also known as: Isoflavone

  • BehavioralSupervised exercise training

    Participants will complete an 8-week supervised exercise intervention consisting of three 60-minute training sessions per week. The program includes aerobic interval cycling and combined aerobic-resistance circuit training with progressive increases in exercise intensity throughout the intervention period.

    Also known as: Training intervention

  • Dietary supplementPlacebo Supplementation

    Participants will consume 120 mL/day of placebo supplement, for 4 weeks prior to and throughout an 8-week supervised exercise training intervention (total duration: 12 weeks). The placebo beverage is matched in appearance and flavor to the active supplement.

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Invasive vascular function

    Changes in vascular function assessed by intra-arterial acetylcholine and epoprostanol infusion in the brachial artery via ultrasound doppler. Measured as changes in conductance (ml/min/mmHg)

    Time frame: Change from week 4 (after supplementation) to week 12 (after exercise plus supplementation)

  2. Invasive vascular function

    Changes in vascular function assessed by intra-arterial acetylcholine and epoprostanol infusion in the brachial artery via ultrasound doppler. Measured as changes in conductance (ml/min/mmHg)

    Time frame: Change from baseline to week 4 (after supplementation)

  3. Mitochondrial function (skeletal muscle)

    Mitochondrial function in skeletal muscle assessed via high resolution respirometry measured in pmol O2/s/mg

    Time frame: Change from week 4 (after supplementation) to week 12 (after exercise plus supplementation)

  4. Mitochondrial function (skeletal muscle)

    Mitochondrial function in skeletal muscle assessed via high resolution respirometry measured in pmol O2/s/mg

    Time frame: Change from baseline to week 4 (after supplementation)

  5. Exercise induced signaling pathways in skeletal muscle (mitochondrial biogenesis and metabolic adaptation) after acute exercise

    Molecular pathways in skeletal muscle involved in exercise adaptation after an acute bout of moderate exercise, including pathways related to energy sensing including AMP-activated protein kinase (AMPK), Mitogen-activated protein kinases (MAPK), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1alpha), Mitochondrial transcription factor A (TFAM) and nitric oxide, endothelial nitric oxide synthase (eNOS) signalling measured with transcriptomics, phosphoproteomics, qPCR and western blot. Measurements will be presented as arbitrary units or fold change.

    Time frame: Baseline (pre acute exercise), immediately after acute exercise, and 3 hours after acute exercise (same study day)

  6. Protein signalling in skeletal muscle

    Changes in skeletal muscle expression of protein. Western blots will be used to determine endothelial nitric oxide synthase (eNOS), cyclo-oxygenase 1 and 2, prostacyclin synthase, endothelin receptor A and B, VEGF (vascular endothelial growth factor), Thrombospondin-1, Flk-1 (VEGF receptor), Mitochondrial Transcription Factor A (TFAM). All protein content measures will be presented as arbitrary units.

    Time frame: Change from baseline to week 4 (after supplementation) to week 12 (after exercise plus supplementation)

Secondary outcomes

  1. Non-invasive vascular function

    Changes in vascular function assessed by flow-mediated dilation measured using ultrasound doppler. Measured as % diameter change from baseline diameter in the resting condition to peak diameter after occlusion.

    Time frame: Change from week 4 (after supplementation) to week 12 (after exercise plus supplementation)

  2. Non-invasive vascular function

    Changes in vascular function assessed by flow-mediated dilation measured using ultrasound doppler. Measured as % diameter change from baseline diameter in the resting condition to peak diameter after occlusion.

    Time frame: Change from baseline to week 4 (after supplementation)

  3. Mitochondrial function, ROS production in skeletal muscle

    Mitochondrial ROS production measured as H2O2 emission (H2O2/O2 flux) via high resolution fluorometry

    Time frame: Change from week 4 (after supplementation) to week 12 (after exercise plus supplementation)

  4. Mitochondrial function, ROS production in skeletal muscle

    Mitochondrial ROS production measured as H2O2 emission (H2O2/O2 flux) via high resolution fluorometry

    Time frame: Change from baseline to week 4 (after supplementation)

  5. Acute changes in mitochondrial function

    Changes in mitochondrial function (respiration, measured as pmol O2/s/mg) after an acute bout of moderate exercise

    Time frame: Baseline (pre acute exercise), immediately after acute exercise, and 3 hours after acute exercise (same study day)

Other outcomes

  1. Body composition

    Body composition measured via Dual-energy X-ray absorptiometry, including lean body mass (kg)

    Time frame: Change from week 4 (after supplementation) to week 12 (after exercise plus supplementation)

  2. Blood pressure

    Changes in systolic and diastolic blood pressure measured via Omrom (mmHg)

    Time frame: Change from baseline to week 4 (after supplementation) to week 12 (after exercise plus supplementation)

  3. Maximal aerobic capacity

    Maximal aerobic capacity measured as maximal oxygen consumption (ml O2/min/kg) via cardio-pulmonary-exercise-test (Vyntus)

    Time frame: Change from week 4 (after supplementation) to week 12 (after exercise plus supplementation)

  4. Maximal aerobic capacity

    Maximal aerobic capacity measured as maximal oxygen consumption (ml O2/min/kg) via cardio-pulmonary-exercise-test (Vyntus)

    Time frame: Change from baseline to week 4 (after supplementation)

  5. Physical activity level

    Changes in physical activity level score (METs minutes per week) assessed by IPAQ questionnaire.

    Time frame: Change from baseline to week 4 (after supplementation) to week 12 (after exercise plus supplementation)

07

Study locations

2 sites
  • Department of Nutrition, Exercise and Sports
    Copenhagen, Storkøbenhavn 2200, Denmark
    • Lasse Gliemann, Associate professor · Contact · gliemann@nexs.ku.dk · 004526746624
    • Lasse Gliemann, Associate professor · Principal investigator
  • Faculty of Medical and Health Sciences
    Copenhagen, 2200, Denmark
    • Steen Larsen, Associate professor · Contact · stelar@sund.ku.dk · 004521151924
    • Steen Larsen, Associate professor · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2027; primary completion for Jun 2029, 19 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2026
First posted
Oct 16, 2026
StartEst.
Oct 15, 2027
Primary completionEst.
Jun 1, 2029
CompletionEst.
Jun 1, 2035
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07878741
Lead sponsor
University of Copenhagen
Responsible party
Lasse Gliemann (Associate professor, University of Copenhagen) — Principal investigator
First posted
Oct 16, 2026
Start date
Oct 15, 2027 (estimated)
Primary completion
Jun 1, 2029 (estimated)
Completion
Jun 1, 2035 (estimated)
Last update
Oct 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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