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NOT YET RECRUITING
NCT07878741
NA

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

Sponsor: University of Copenhagen

View on ClinicalTrials.gov

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.

Official title: Effekten af Isoflavontilskud og Fysisk træning på Kardiometabolisk Funktion Hos Postmenopausal Kvinder

Key Details

Gender

FEMALE

Age Range

45 Years - 61 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2027-10-15

Completion Date

2035-06-01

Last Updated

2026-10-16

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Red 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).

BEHAVIORAL

Supervised 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.

DIETARY_SUPPLEMENT

Placebo 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.

Locations (2)

Department of Nutrition, Exercise and Sports

Copenhagen, Storkøbenhavn, Denmark

Faculty of Medical and Health Sciences

Copenhagen, Denmark