Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health

University of Valencia

Status: Enrolling

Conditions: Aging; Perimenopause

Treatments: Dietary Supplement: Exercise + nutritional supplement; Dietary Supplement: Exercise + placebo supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07251296

2025-FIS-4025659

Details and patient eligibility

About

The goal of this clinical trial is to learn whether a natural-origin nutritional supplement, combined with a functional exercise program, can improve psycho-emotional, cognitive, functional, and neuroendocrine health in perimenopausal women. The study will also help determine the safety of this combined intervention.

The main questions it aims to answer are:

• Does the combined intervention improve mood, sleep quality, menopausal symptoms, and cognitive performance?
• Does it enhance physical function and neuroendocrine regulation?

Researchers will compare the supplement to a placebo. All participants will follow the same supervised functional exercise program.

Participants will:

• Take a daily nutritional supplement or placebo for 10 weeks
• Attend three weekly supervised functional exercise sessions (45-60 minutes each)
• Complete pre- and post-intervention evaluations including questionnaires, physical and cognitive tests, and blood samples for biomarker analysis.

Full description

This study is a randomized, double-blind, placebo-controlled clinical trial with parallel groups, designed to evaluate the effects of a natural-origin nutritional supplement combined with a functional physical exercise program on psycho-emotional, cognitive, functional, and neuroendocrine variables in perimenopausal women. Participants will be randomly assigned to the intervention groups, with both participants and outcome assessors blinded to group allocation (double-blind design). All study groups will receive a functional exercise intervention, in addition to the nutritional supplement or placebo.

The study will last a total of 10 weeks and will include a supervised functional exercise program consisting of three weekly sessions, each lasting 45 to 60 minutes. Pre- and post-intervention assessments will be conducted, including validated questionnaires on sleep quality, mood, general well-being, and menopausal symptoms; objective cognitive tests (attention, working memory, and executive functions); physical fitness assessments (strength, agility, gait speed, body composition); and blood analyses of neuroendocrine biomarkers (cortisol, BDNF, IL-6, TNF-α, GABA, and serotonin).

This methodological design will allow for both within- and between-group comparisons and the analysis of potential interactions between the interventions, in order to determine their efficacy and safety as non-pharmacological strategies to improve the overall health of perimenopausal women.

Enrollment: 90 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged between 45 and 65 years.
• In the menopausal transition (defined by irregular menstrual cycles and typical symptoms within the past year) or postmenopause.
• Score ≥ 8 on the Menopause Rating Scale (MRS), indicating moderate menopausal symptom intensity.
• Regular nighttime sleep and not engaged in shift work.
• Low physical activity level: less than 150 minutes per week of moderate or vigorous physical activity, as assessed by the short-form IPAQ or a similar questionnaire.
• Body mass index (BMI) between 18.5 and 35 kg/m².
• Sufficient functional and cognitive capacity to participate in supervised physical exercise and follow the study protocol.
• Signed informed consent and availability to attend all scheduled sessions and assessments.

Exclusion criteria

• Current or recent (within the last 3 months) use of hormone replacement therapy (HRT).
• Surgical, induced, or early menopause (before age 40).
• Current treatment with medications that may affect mood, sleep, or vasomotor symptoms, including: antidepressants (SSRIs, SNRIs, tricyclics); anxiolytics or hypnotics; phytoestrogens, isoflavones, or other over-the-counter hormonal supplements.
• Medical diagnosis of severe or uncontrolled chronic diseases, including cardiovascular, respiratory (particularly sleep apnea), metabolic, active oncological, neurological, severe autoimmune, or psychiatric disorders.
• Regular use within the past 3 months of nutritional or sports supplements that may interfere with study outcomes (e.g., creatine, protein, omega-3, adaptogens, etc.).
• Medical contraindications for moderate-to-vigorous physical exercise, as determined by the PAR-Q+ questionnaire and/or updated medical report.
• Simultaneous participation in another clinical trial or intervention program involving drugs, supplements, or structured physical exercise of any kind.
• Known allergy or intolerance to any component of the nutritional supplement to be administered.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Exercise + nutritional supplement (Gr 1: EXNS)

Experimental group

Description:

Participants in this group will receive a daily dose of the natural-origin nutritional supplement in combination with a supervised functional exercise program (3 sessions per week, 45-60 minutes each) for 10 weeks.

Treatment:

Dietary Supplement: Exercise + nutritional supplement

Exercise + placebo supplement (Gr 2: EXPLA)

Placebo Comparator group

Description:

Participants in this group will receive a placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks.

Treatment:

Dietary Supplement: Exercise + placebo supplement