PerimenopauseNCT07863973
Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause
A study testing Plant Extract-Based Dietary Supplement in people with Perimenopause and Postmenopause, run by University of Alicante at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 42 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Postmenopause, Hot Flashes
- What is being tested?
- Plant Extract-Based Dietary Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2026to 31 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Body mass index of 35 kg/m² or less.
- Written informed consent.
Who cannot join
- 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.
- Any circumstance that, in the investigator's judgment, would hinder compliance with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
European Institute Of Exercise and Health
Elche, Alicante, 03202
ALEJANDRO MARTÍNEZ RODRÍGUEZ, 696210163
About this study
Official title: Study of the Effect of a Dietary Supplement on Health Indicators in Women With Late Perimenopause and Early Postmenopause
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group study conducted at EIEH Clinic in Elche, Spain.
Approximately 120 women aged 42 to 60 years with late perimenopause or early postmenopause and at least five moderate or severe hot flashes per day during the screening period will be enrolled.
Participation will last approximately 14 weeks, comprising a two-week screening period followed by a 12-week intervention period. Participants will attend six in-person visits and will be randomly assigned to one of two groups: a plant extract-based dietary supplement or placebo. The assigned product will be taken daily throughout the intervention. Participants and the research team will remain blinded to treatment allocation during the study.
Hot flash and night sweat frequency and severity will be recorded using a daily diary. Menopausal symptoms and menopause-related quality of life will be assessed using the Menopause Rating Scale (MRS) and the Menopause-Specific Quality of Life Questionnaire (MENQOL). Additional assessments will include sleep quality, emotional well-being, perceived cognitive function, physical activity, dietary habits, and adherence to the Mediterranean diet.
Body composition will be assessed by bioelectrical impedance analysis, together with body weight, height, body mass index, and body circumferences. Blood samples will be collected at baseline and at the end of the intervention to assess selected hormonal, biochemical, and hematological parameters.
Adherence will be monitored through study product counts and adherence records. Adverse events and other relevant incidents will be recorded throughout the study. Changes over time will be compared between the intervention and placebo groups.
- Conditions
- Perimenopause, Postmenopause, Hot Flashes
- Being tested
- Plant Extract-Based Dietary Supplement, Placebo
- Keywords
- Menopause, Vasomotor symptoms, Night sweats, Dietary supplement, Plant extracts, Menopause-related quality of life
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant Extract-Based Dietary SupplementDietary supplement
A dietary supplement containing plant extracts, supplied by Monteloeder and administered daily for 12 weeks.
PlaceboOther
Placebo administered daily for 12 weeks as the control intervention.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | Participants will receive a plant extract-based dietary supplement daily for 12 weeks. Receives: Dietary Supplement: Plant Extract-Based Dietary Supplement |
| Placebo | Placebo comparator | Participants will receive placebo daily for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Weeks 4, 8, and 12
Secondary outcomes (14)
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.
Measured: Baseline and Week 12
Number of Participants With Adverse Events
Number of participants experiencing at least one adverse event during the intervention.
Measured: Throughout the 12-week intervention
Change From Baseline in Body Weight
Change in body weight, measured in kilograms.
Measured: Baseline and Weeks 4, 8, and 12
Change From Baseline in Body Mass Index
Change in body mass index, calculated as body weight in kilograms divided by height in meters squared.
Measured: Baseline and Weeks 4, 8, and 12
Change From Baseline in Fasting Blood Glucose
Change in fasting blood glucose concentration, measured in mg/dL.
Measured: Baseline and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin, expressed as a percentage.
Measured: Baseline and Week 12
Study Product Adherence
Percentage of prescribed study product doses taken during the intervention, assessed using returned product counts and adherence records.
Measured: Throughout the 12-week intervention
Change From Baseline in Waist Circumference
Change in waist circumference, measured in centimeters.
Measured: Baseline and Weeks 4, 8, and 12
Change From Baseline in Hip Circumference
Change in hip circumference, measured in centimeters.
Measured: Baseline and Weeks 4, 8, and 12
Change From Baseline in State Anxiety Score
Change in state anxiety assessed using the Spanish State-Trait Anxiety Inventory (STAI). The state anxiety subscale contains 20 items scored from 0 to 3. After reverse scoring the appropriate items, total scores range from 0 to 60, with higher scores indicating greater anxiety.
Measured: Baseline and Week 12
Change From Baseline in Self-Rated Health on the EQ Visual Analogue Scale
Change in self-rated health assessed using the EQ visual analogue scale. Scores range from 0, representing the worst imaginable health, to 100, representing the best imaginable health. Higher scores indicate better self-rated health.
Measured: Baseline and Week 12
Change From Baseline in Physical Activity Assessed by IPAQ Short Form
Change from baseline in total physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), referring to activity during the previous seven days.
Total physical activity is calculated by summing walking, moderate-intensity, and vigorous-intensity activity, expressed as metabolic equivalent of task (MET)-minutes per week. The minimum value is 0 MET-minutes/week. This continuous measure has no fixed maximum before application of the questionnaire's data-processing rules.
Higher values indicate greater reported physical activity; they do not directly represent better or worse health outcomes.
Measured: Baseline and Week 12
Change From Baseline in 14-Item Mediterranean Diet Adherence Score
Change in adherence to the Mediterranean diet assessed using the 14-item questionnaire included in the study assessment battery. Each item is scored 0 or 1 according to its specified dietary criterion. Total scores range from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.
Measured: Baseline and Week 12
Change From Baseline in Perceived Deficits Questionnaire-Depression 5-Item (PDQ-D-5) Total Score
Change in subjective cognitive difficulties assessed using the PDQ-D-5. The questionnaire contains five items assessing the frequency of perceived cognitive difficulties over the previous seven days. Each item is scored from 0 to 4, yielding a total score from 0 to 20. Higher scores indicate greater perceived cognitive difficulties.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive either a plant extract-based dietary supplement or placebo daily for 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863973
- Sponsor's protocol ID
- UA-2026-07-16
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No