An interventional study of Full Spectrum hop extract (MENODUO FullSpectrum) and Soy isoflavone extract in Menopause, Perimenopause and Postmenopause, sponsored by Menoclinica by Palacios. Recruiting at 1 site in Spain. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Menoclinica by Palacios · Not applicable, Interventional, and Treatment
HOPES (Hops On Psychological and Estrogenic Symptoms in Menopause) is a randomized, double-blind, active-controlled nutritional intervention study in 120 peri- and postmenopausal women aged 45 to 60 years with moderate to severe menopausal symptoms. For 12 weeks, participants take one capsule per day of either a full spectrum hop (Humulus lupulus L.) extract or a soy isoflavone extract. Both products are marketed dietary supplements, and there is no placebo arm.
The main question is whether the hop extract, which combines prenylated flavonoids with bitter acids, improves the psychological symptoms of menopause (depressive mood, irritability, anxiety, and physical and mental exhaustion) more than the soy extract. The main outcome is the change in the psychological subscale of the Menopause Rating Scale (MRS) from baseline to week 12.
Secondary outcomes include the other MRS domains, anxiety, depressive symptoms, menopause-related quality of life, body composition, and safety.
Rationale
Many women cannot or do not wish to use menopausal hormone therapy (MHT) and turn to plant-based supplements. Soy isoflavones act mainly through estrogenic mechanisms and have shown a modest effect on vasomotor symptoms, while the evidence for psychological symptoms and sleep is more limited and less consistent. Hop extract has a dual profile: prenylated flavonoids, linked to estrogenic activity, and bitter acids, described in relation to GABAergic neurotransmission and vagal signalling. No direct comparison of the two extracts is available. HOPES tests whether this profile gives the hop extract a differential effect on the psychological domain of menopausal symptoms.
Design
Candidates complete a secure online screening (visit 0). Eligible women attend a baseline visit (visit 1) at the coordinating center, where eligibility is confirmed, assessments and a blood sample are taken, and participants are randomized 1:1 (computer-generated permuted blocks of variable size, stratified by center and menopausal status: perimenopause or postmenopause). Follow-up includes a visit at week 6 (visit 2, in person or remote) and a final visit at week 12 (visit 3).
Capsules and bottles are identical and coded by the sponsor. Participants, the research team and the statistician remain masked until database lock, and an emergency unblinding procedure is available. Adherence is assessed with a capsule diary and a count of returned product, and dietary intake with a 3-day food record at visits 1 and 3.
Assessments
Menopause Rating Scale (MRS), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Cervantes-31 quality of life scale, and 0-10 visual analogue scales (VAS) for hot flashes, sleep quality and mood; body composition by bioimpedance; and blood tests (liver profile, lipid profile, estradiol and follicle-stimulating hormone) at baseline and week 12.
Analysis
The primary outcome is analyzed in the intention-to-treat population with a mixed model for repeated measures. With 60 participants per arm, the study has 80% power, at a two-sided significance level of 5%, to detect a standardized effect size of about 0.52. Secondary outcomes are tested hierarchically.
A between-group difference of at least 0.5 standard deviations in the change of the MRS psychological subscale is prespecified as clinically relevant.
Menoclinica by Palacios is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One capsule per day for 12 weeks of MENODUO FullSpectrum, a dry hop (Humulus lupulus L.) strobilus extract, 100 mg/day, providing 10 mg/day of bitter acids and derivatives, 3.5 mg/day of prenylated flavonoids and 2.5 mg/day of xanthohumol.
Dietary Supplement: Full Spectrum hop extract (MENODUO FullSpectrum)
One capsule per day for 12 weeks of a dry soy (Glycine max (L.) Merr.) seed extract, 100 mg/day, standardized to at least 40% total isoflavones (at least 40 mg/day) and selected to provide at least 20 mg/day of genistein.
Dietary Supplement: Soy isoflavone extract
100 mg/day orally, one capsule per day for 12 weeks. Provides 10 mg/day of bitter acids and derivatives, 3.5 mg/day of prenylated flavonoids and 2.5 mg/day of xanthohumol.
Also known as: MENODUO FullSpectrum
Description: 100 mg/day orally, one capsule per day for 12 weeks. Standardized to at least 40% total isoflavones (at least 40 mg/day) and at least 20% genistein (at least 20 mg/day).
Change in the psychological subscale score of the Menopause Rating Scale (MRS)
The MRS psychological subscale is the sum of items 4 to 7 (depressive mood, irritability, anxiety, and physical and mental exhaustion), each rated from 0 (none) to 4 (very severe). Score range 0 to 16; higher scores indicate greater symptom severity. Change is the week 12 score minus the baseline score.
Time frame: Baseline (visit 1) and week 12 (visit 3)
Change in total MRS score
Sum of the 11 MRS items, each rated 0 to 4. Score range 0 to 44; higher scores indicate greater severity.
Time frame: Baseline, week 6 and week 12
Change in MRS somatic-vegetative subscale score
Sum of items 1, 2, 3 and 11. Score range 0 to 16; higher scores indicate greater severity.
Time frame: Baseline, week 6 and week 12
Change in MRS urogenital subscale score
Sum of items 8, 9 and 10. Score range 0 to 12; higher scores indicate greater severity.
Time frame: Baseline, week 6 and week 12
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Seven items rated 0 to 3. Score range 0 to 21; higher scores indicate more anxiety symptoms.
Time frame: Baseline and week 12 (optional at week 6)
Change in Patient Health Questionnaire-9 (PHQ-9) score
Nine items rated 0 to 3. Score range 0 to 27; higher scores indicate more depressive symptoms.
Time frame: Baseline and week 12 (optional at week 6)
Change in the Cervantes Scale global score
The Cervantes Scale is a 31-item, menopause-specific health-related quality of life questionnaire. Each item is rated from 0 to 5. The global score ranges from 0 to 155; higher scores indicate worse health-related quality of life. Change is the week 12 score minus the baseline score.
Time frame: Baseline and week 12
Change in the Cervantes Scale sexuality domain score
The sexuality domain of the Cervantes Scale (31-item, menopause-specific health-related quality of life questionnaire) comprises 4 items on sexual function, each rated from 0 to 5. The domain score ranges from 0 to 20; higher scores indicate worse sexual function. Change is the week 12 score minus the baseline score.
Time frame: Baseline and week 12
Change in body fat percentage
Body fat percentage measured by bioimpedance.
Time frame: Baseline and week 12
Change in estimated visceral fat
Visceral fat estimate measured by bioimpedance.
Time frame: Baseline and week 12
Change in hot flash intensity (visual analogue scale)
0-10 scale; 0 = no hot flashes, 10 = maximum imaginable intensity.
Time frame: Baseline, week 6 and week 12
Change in sleep quality (visual analogue scale)
0-10 scale; 0 = very poor sleep quality, 10 = excellent sleep quality.
Time frame: Baseline, week 6 and week 12
Change in mood (visual analogue scale)
0-10 scale; 0 = very poor mood, 10 = excellent mood.
Time frame: Baseline, week 6 and week 12
Number of participants with adverse events
Incidence, nature, severity, duration and relationship to the intervention, including events that lead to interruption of the intervention or withdrawal.
Time frame: From baseline to week 12
Change in liver profile
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase and bilirubin.
Time frame: Baseline and week 12
Change in lean mass
Lean mass in kilograms measured by bioimpedance.
Time frame: Baseline and week 12
Change in lipid profile
Total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides.
Time frame: Baseline and week 12
Change in serum estradiol
Serum estradiol concentration.
Time frame: Baseline and week 12
Change in serum follicle-stimulating hormone (FSH)
Serum FSH concentration.
Time frame: Baseline and week 12
Plan to share: No — Individual participant data will not be shared at this stage. Aggregate results will be published in a peer-reviewed journal.
Started Oct 2026 (actual). Primary completion is estimated for Feb 2027, 3 months after the start.
How these figures are worked out, and which studies are left out of them.
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 ↗
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Menoclinica by Palacios