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)
Sponsor study identifier
Secondary identifiers
OTHER · Research Ethics Committee (CEIm), Hospital Universitario de La Princesa
interventional
120
1 country
1
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
February 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 23, 2026
Actual (reported)October 29, 2026
Actual (reported)February 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline (visit 1) and week 12 (visit 3)
Change in total MRS score
Baseline, week 6 and week 12
Change in MRS somatic-vegetative subscale score
Baseline, week 6 and week 12
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.
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.
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.
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).
Menoclínica by Palacios
Madrid, Madrid, 28009, Spain
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.
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.
Silvia Pilar González Rodríguez
Menoclínica by Palacios
First Submitted
October 23, 2026
First Posted
October 29, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in MRS urogenital subscale score
Baseline, week 6 and week 12
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Baseline and week 12 (optional at week 6)
Change in Patient Health Questionnaire-9 (PHQ-9) score
Baseline and week 12 (optional at week 6)
Change in lipid profile
Baseline and week 12
Change in serum estradiol
Baseline and week 12
Change in serum follicle-stimulating hormone (FSH)
Baseline and week 12
Contact the study team to confirm eligibility.
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.
Primary Completion
February 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Individual participant data will not be shared at this stage. Aggregate results will be published in a peer-reviewed journal.
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Source: ClinicalTrials.gov.
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