Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES) (HOPES)
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Esmeralda Josa
- Numéro de téléphone: +34 914 324 499
- E-mail: esmeralda.josa@menoclinica.com
Lieux d'étude
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Madrid
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Madrid, Madrid, Espagne, 28009
- Recrutement
- Menoclínica by Palacios
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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.
Autres noms:
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Comparateur actif: 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. |
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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the psychological subscale score of the Menopause Rating Scale (MRS)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in total MRS score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and week 12
|
Body fat percentage measured by bioimpedance. |
Baseline and week 12
|
|
Change in estimated visceral fat
Délai: Baseline and week 12
|
Visceral fat estimate measured by bioimpedance. |
Baseline and week 12
|
|
Change in hot flash intensity (visual analogue scale)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and week 12
|
Lean mass in kilograms measured by bioimpedance. |
Baseline and week 12
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in lipid profile
Délai: 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
Délai: Baseline and week 12
|
Serum estradiol concentration. |
Baseline and week 12
|
|
Change in serum follicle-stimulating hormone (FSH)
Délai: Baseline and week 12
|
Serum FSH concentration. |
Baseline and week 12
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Silvia Pilar González Rodríguez, Menoclínica by Palacios
Publications et liens utiles
Publications générales
- Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
- Palacios S, Ferrer-Barriendos J, Parrilla JJ, Castelo-Branco C, Manubens M, Alberich X, Marti A; Grupo Cervantes. [Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale]. Med Clin (Barc). 2004 Feb 21;122(6):205-11. doi: 10.1016/s0025-7753(04)74198-6. Spanish.
- Morimoto-Kobayashi Y, Ohara K, Ashigai H, Kanaya T, Koizumi K, Manabe F, Kaneko Y, Taniguchi Y, Katayama M, Kowatari Y, Kondo S. Matured hop extract reduces body fat in healthy overweight humans: a randomized, double-blind, placebo-controlled parallel group study. Nutr J. 2016 Mar 9;15:25. doi: 10.1186/s12937-016-0144-2.
- Keiler AM, Zierau O, Kretzschmar G. Hop extracts and hop substances in treatment of menopausal complaints. Planta Med. 2013 May;79(7):576-9. doi: 10.1055/s-0032-1328330. Epub 2013 Mar 19.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HOPES-2026-01
- 6554 (Autre identifiant: Research Ethics Committee (CEIm), Hospital Universitario de La Princesa)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data will not be shared at this stage. Aggregate results will be published in a peer-reviewed journal.
Informations sur les médicaments et les dispositifs, documents d'étude
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