Effect of HIFAS MENOPAUSE on Quality of Life in Postmenopausal Women

Hifas da Terra S.L.20 enrolled

Overview

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.

This was a prospective, single-center, single-group, open-label, pre-post interventional study conducted in postmenopausal women with mild to moderate menopausal symptoms. The study included no concurrent control group, and each participant served as her own control. Eligible participants were postmenopausal women aged 40 to 60 years whose last menstrual period had occurred at least 12 months before screening. Participants received HIFAS MENOPAUSE, a dietary supplement, at a dose of two oral capsules once daily while fasting for 24 weeks. Study visits were conducted at the following time points: Baseline, before starting treatment Week 4 Week 12 Week 24 Menopause-related quality of life was assessed using the short-form Cervantes Scale. Menopausal symptom severity was evaluated using the Menopause Rating Scale. Other assessments included weekly hot-flash frequency recorded in a participant diary, difficulty concentrating measured using a visual analog scale, vaginal pH, the Vaginal Health Index, and the cytological maturation index. Adverse events and concomitant treatments were recorded during follow-up. Treatment adherence, tolerability, and participant satisfaction were also evaluated. Changes observed at weeks 4, 12, and 24 were compared with baseline measurements. The final study assessment was performed at week 24.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Interventions

HIFAS MENOPAUSEDIETARY_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.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.