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Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES) (HOPES)

4 novembre 2026 aggiornato da: Silvia Pilar González Rodríguez, Menoclinica by Palacios

Efficacy of a Full Spectrum Hop (Humulus Lupulus L.) Extract Versus a Soy Extract in Women With Menopausal Symptoms: A Randomized, Double-Blind, Active-Controlled Nutritional Intervention Study (HOPES: Hops On Psychological and Estrogenic Symptoms in Menopause)

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Spagna
    • Madrid
      • Madrid, Madrid, Spagna, 28009
        • Reclutamento
        • Menoclínica by Palacios

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 45 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Woman aged 45 to 60 years (both inclusive).
  • Perimenopausal or postmenopausal status according to the Stages of Reproductive Aging Workshop +10 (STRAW+10) criteria.
  • Moderate to severe menopausal symptoms, defined as a total Menopause Rating Scale (MRS) score of 15 or higher at the baseline assessment prior to randomization.
  • Not receiving menopausal hormone therapy (MHT) and not having received it in the previous 3 months.
  • Ability to understand and complete the study questionnaires autonomously.
  • Written informed consent.

Exclusion Criteria:

  • Known allergy or hypersensitivity to soy or any of its derivatives.
  • Known allergy or hypersensitivity to hops or to other species of the Cannabaceae family.
  • Personal history of breast cancer, endometrial cancer or any other hormone-dependent tumor.
  • Genital bleeding of undiagnosed cause.
  • Current use, or use in the previous 3 months, of MHT, tibolone, selective estrogen receptor modulators, or dietary supplements or products specifically intended for menopausal symptoms or with a relevant phytoestrogen content, or anticipated need to start any of them during the study.
  • Current treatment with antidepressants, anxiolytics, hypnotics, gabapentin or pregabalin.
  • Known liver disease or abnormal baseline liver profile (transaminases more than twice the upper limit of normal).
  • Moderate or severe renal insufficiency.
  • History of venous thromboembolic disease.
  • Oral anticoagulant treatment.
  • Body mass index (BMI) of 35 kg/m2 or higher.
  • Pacemaker or any other implantable electronic device (contraindication for bioimpedance).
  • Unstabilized major psychiatric disorder.
  • Risky alcohol consumption or substance dependence.
  • Simultaneous participation in another clinical trial or intervention study, or participation in one within the previous 30 days.
  • Pregnancy or lactation.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Hop extract

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.
Integratore alimentare: Full Spectrum hop extract (MENODUO FullSpectrum)

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.

Altri nomi:
  • MENODUO FullSpectrum
Comparatore attivo: Soy extract

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.
Integratore alimentare: Soy isoflavone extract

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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the psychological subscale score of the Menopause Rating Scale (MRS)
Lasso di tempo: Baseline (visit 1) and week 12 (visit 3)

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.
Baseline (visit 1) and week 12 (visit 3)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in total MRS score
Lasso di tempo: Baseline, week 6 and week 12

Sum of the 11 MRS items, each rated 0 to 4. Score range 0 to 44; higher scores indicate greater severity.
Baseline, week 6 and week 12
Change in MRS somatic-vegetative subscale score
Lasso di tempo: Baseline, week 6 and week 12

Sum of items 1, 2, 3 and 11. Score range 0 to 16; higher scores indicate greater severity.
Baseline, week 6 and week 12
Change in MRS urogenital subscale score
Lasso di tempo: Baseline, week 6 and week 12

Sum of items 8, 9 and 10. Score range 0 to 12; higher scores indicate greater severity.
Baseline, week 6 and week 12
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Lasso di tempo: Baseline and week 12 (optional at week 6)

Seven items rated 0 to 3. Score range 0 to 21; higher scores indicate more anxiety symptoms.
Baseline and week 12 (optional at week 6)
Change in Patient Health Questionnaire-9 (PHQ-9) score
Lasso di tempo: Baseline and week 12 (optional at week 6)

Nine items rated 0 to 3. Score range 0 to 27; higher scores indicate more depressive symptoms.
Baseline and week 12 (optional at week 6)
Change in the Cervantes Scale global score
Lasso di tempo: Baseline and week 12

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.
Baseline and week 12
Change in the Cervantes Scale sexuality domain score
Lasso di tempo: Baseline and week 12

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.
Baseline and week 12
Change in body fat percentage
Lasso di tempo: Baseline and week 12

Body fat percentage measured by bioimpedance.
Baseline and week 12
Change in estimated visceral fat
Lasso di tempo: Baseline and week 12

Visceral fat estimate measured by bioimpedance.
Baseline and week 12
Change in hot flash intensity (visual analogue scale)
Lasso di tempo: Baseline, week 6 and week 12

0-10 scale; 0 = no hot flashes, 10 = maximum imaginable intensity.
Baseline, week 6 and week 12
Change in sleep quality (visual analogue scale)
Lasso di tempo: Baseline, week 6 and week 12

0-10 scale; 0 = very poor sleep quality, 10 = excellent sleep quality.
Baseline, week 6 and week 12
Change in mood (visual analogue scale)
Lasso di tempo: Baseline, week 6 and week 12

0-10 scale; 0 = very poor mood, 10 = excellent mood.
Baseline, week 6 and week 12
Number of participants with adverse events
Lasso di tempo: From baseline to week 12

Incidence, nature, severity, duration and relationship to the intervention, including events that lead to interruption of the intervention or withdrawal.
From baseline to week 12
Change in liver profile
Lasso di tempo: Baseline and week 12

Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase and bilirubin.
Baseline and week 12
Change in lean mass
Lasso di tempo: Baseline and week 12

Lean mass in kilograms measured by bioimpedance.
Baseline and week 12

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in lipid profile
Lasso di tempo: Baseline and week 12

Total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides.
Baseline and week 12
Change in serum estradiol
Lasso di tempo: Baseline and week 12

Serum estradiol concentration.
Baseline and week 12
Change in serum follicle-stimulating hormone (FSH)
Lasso di tempo: Baseline and week 12

Serum FSH concentration.
Baseline and week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Menoclinica by Palacios

Investigatori

  • Investigatore principale: Silvia Pilar González Rodríguez, Menoclínica by Palacios

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 ottobre 2026

Completamento primario (Stimato)

5 febbraio 2027

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

23 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 ottobre 2026

Primo Inserito (Effettivo)

29 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HOPES-2026-01
  • 6554 (Altro identificatore: Research Ethics Committee (CEIm), Hospital Universitario de La Princesa)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared at this stage. Aggregate results will be published in a peer-reviewed journal.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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