Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age42-60
SponsorUniversity of Alicante
About this trial
This study will evaluate the effects of a plant extract-based dietary supplement on menopausal symptoms and health indicators in women with late perimenopause or early postmenopause.
Approximately 120 women aged 42 to 60 years will be randomly assigned to receive either the dietary supplement or a placebo daily for 12 weeks. Neither the participants nor the research team will know the assigned treatment during the study.
Assessments will include the frequency and severity of hot flashes and night sweats, menopausal symptoms, quality of life, sleep quality, emotional well-being, body composition, and selected laboratory parameters.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 42 to 60 years.
Late perimenopause or early postmenopause.
Amenorrhea for at least 3 months and no more than 10 years since menopause.
At least five moderate or severe hot flashes per day during the screening period.
Disqualifiers
Serious uncontrolled diseases.
Treatments that may interfere with the assessment of the primary outcome measures.
Known allergy or intolerance to any component of the study product.
Concurrent participation in another clinical trial.
Trial design
Design model
Parallel
Treatments tested in this trial
Plant Extract-Based Dietary Supplement
Dietary supplementA dietary supplement containing plant extracts, supplied by Monteloeder and administered daily for 12 weeks.
Placebo
Other interventionPlacebo administered daily for 12 weeks as the control intervention.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Dietary SupplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Menopause Rating Scale (MRS) Total Score
Change in menopausal symptom severity assessed using the Menopause Rating Scale (MRS). The questionnaire includes 11 items scored from 0 to 4, with a total score ranging from 0 to 44. Higher scores indicate more severe symptoms.
Time frame
Baseline and Week 122
Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Domain Scores
Change in menopause-related quality of life assessed using the MENQOL questionnaire across its vasomotor, psychosocial, physical, and sexual domains. Domain scores range from 1 to 8, with higher scores indicating greater symptom-related bother and poorer quality of life.
Time frame
Baseline and Weeks 4, 8, and 12Secondary outcomes
1
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
Change in sleep quality assessed using the PSQI. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame
Baseline and Week 122
Number of Participants With Adverse Events
Number of participants experiencing at least one adverse event during the intervention.
Time frame
Throughout the 12-week intervention3
Change From Baseline in Body Weight
Change in body weight, measured in kilograms.
Time frame
Baseline and Weeks 4, 8, and 124
Change From Baseline in Body Mass Index
Change in body mass index, calculated as body weight in kilograms divided by height in meters squared.
Time frame
Baseline and Weeks 4, 8, and 12Sponsors and contacts
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Source ClinicalTrials.gov