Effect of HIFAS MENOPAUSE on Quality of Life in Postmenopausal Women

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.

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.