Effect of HIFAS MENOPAUSE on Quality of Life in Postmenopausal Women

NCT07752641 | Completed

• 1 other identifier: Hifas 2024-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, single-group, open-label study evaluated changes in menopause-related quality of life and menopausal symptoms in postmenopausal women aged 40 to 60 years after 24 weeks of treatment with HIFAS MENOPAUSE. Participants took two capsules of HIFAS MENOPAUSE orally once daily while fasting for 24 weeks. Study assessments were performed at baseline and after 4, 12, and 24 weeks of treatment. The primary objective was to evaluate change in menopause-related quality of life using the short-form Cervantes Scale. Additional assessments included menopausal symptom severity, weekly hot-flash frequency, difficulty concentrating, vulvovaginal health, vaginal pH, cytological maturation, treatment adherence, tolerability, satisfaction, and adverse events.

Conditions

Menopausal Symptoms; Menopause

Keywords

Postmenopausal Women; Menopause-Related Quality of Life; Menopause Rating Scale; Cervantes Scale; Hot Flashes; Dietary Supplement

Outcome Measures

Primary Outcomes (1)

• Change from baseline in menopause-related quality of life assessed with the short-form Cervantes scale

  Change from baseline in the total score of the 16-item short-form Cervantes Scale, used to assess menopause-related quality of life. The total score ranges from 0 (minimum) to 80 (maximum). Higher scores indicate a greater negative impact of menopause on quality of life, representing a worse outcome. Therefore, a decrease from baseline indicates improvement.

  Baseline and Weeks 4, 12, and 24

Secondary Outcomes (12)

• Change from baseline in menopausal symptom severity assessed with the menopause rating scale

  Baseline and Weeks 4, 12, and 24

• Weekly hot flash frequency

  Weeks 4, 12, and 24

• Change from baseline in difficulty concentrating assessed with the Visual Analog Scale for difficulty concentrating

  Baseline and Weeks 4, 12, and 24

• Change from baseline in vulvovaginal health assessed with the Vaginal Health Index

  Baseline and Weeks 4, 12, and 24

• Change from baseline in vaginal pH

  Baseline and Weeks 4, 12, and 24

Study Arms (1)

HIFAS MENOPAUSE

EXPERIMENTAL

Participants received HIFAS MENOPAUSE, a symbiotic dietary supplement, at a dose of two capsules orally once daily while fasting for 24 weeks. Outcomes were assessed at baseline and at weeks 4, 12, and 24. No concurrent comparator or control arm was included.

Dietary Supplement: HIFAS MENOPAUSE

Interventions

HIFAS MENOPAUSE DIETARY_SUPPLEMENT

HIFAS MENOPAUSE is a symbiotic dietary supplement administered as two oral capsules once daily while fasting for 24 weeks. Each daily dose contained Hericium erinaceus fruiting body powder 280 mg, Cordyceps sinensis mycelial extract 240 mg, Ganoderma lucidum fruiting body extract 100 mg, ashwagandha root extract 100 mg, green tea leaf extract 100 mg, a probiotic blend containing Bifidobacterium lactis, Lactobacillus plantarum, Bifidobacterium infantis, Lactobacillus acidophilus, and Bifidobacterium longum, as well as zinc, vitamin B6, vitamin A, and vitamin D. The study product was provided by Hifas da Terra, S.L.

HIFAS MENOPAUSE

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postmenopausal women, defined as having had their last menstrual period at least 12 months before screening.
• Age 40 to 60 years, inclusive.
• Vaginal pH ≥5.
• Menopause Rating Scale (MRS) total score ≥20.
• Willing and able to provide written informed consent, take HIFAS MENOPAUSE, complete the study questionnaires, records, and diaries, and attend all scheduled study visits.
• Willing to discontinue prebiotic supplements and foods containing added prebiotics or live and active cultures for a 4-week washout period before enrollment.

You may not qualify if:

• Menopause induced by total or partial hysterectomy, chemotherapy, or radiotherapy.
• Use of natural health products intended to treat menopausal symptoms, including phytoestrogens, black cohosh, dehydroepiandrosterone (DHEA), dong quai, vitamin E at doses greater than 250 IU/day, or high consumption of soy-based foods, unless the required washout period had been completed.
• Current or previous menopausal hormone therapy for menopausal symptoms, unless the required washout period had been completed.
• Acute vaginal infection, urinary tract infection, genital bleeding of unknown origin, or another clinically relevant gynecological condition.
• Use of vaginal medications, vaginal douches, moisturizers, or gels containing lidocaine or other analgesic products intended to reduce pain during sexual intercourse within 1 week before enrollment or during the study.
• Previous diagnosis of hyperparathyroidism or hyperthyroidism.
• Participation in another clinical study within the previous 6 months.
• History of alcohol or drug abuse within the 12 months before screening.
• History of cancer within 5 years before screening, except localized nonmetastatic skin cancer.
• History of any clinically significant disease or disorder that, in the investigator's opinion, could place the participant at risk, affect the study results, or impair the participant's ability to complete the study.
• History or presence of gastrointestinal, hepatic, or renal disease, or another condition known to interfere with the absorption, distribution, metabolism, or excretion of medicinal products, including Crohn disease, short bowel syndrome, acute or chronic pancreatitis, or pancreatic insufficiency.
• History of bariatric surgery, including gastric bypass or gastric banding.
• Current consumption of more than two standard alcoholic drinks per day. One standard drink was defined as 355 mL of beer, 150 mL of wine, or 45 mL of spirits.
• Difficulty swallowing large tablets or a large number of tablets.
• Any condition or abnormality that, in the investigator's opinion, could compromise participant safety or the quality of the study data.

Sponsors & Collaborators

• Hifas da Terra S.L.: lead

Study Sites (1)

Instituto Palacios, Salud y Medicina de la Mujer

Madrid, Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants received HIFAS MENOPAUSE, two capsules orally once daily while fasting for 24 weeks. Outcomes were assessed at baseline and at weeks 4, 12, and 24. Each participant served as her own control, and no concurrent comparator group was included.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start: February 14, 2025
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)