The role of nutrition is recognized as a vital component to healthy aging throughout menopause. The goal of this study is to evaluate a dietary supplement for its safety and effects on vasomotor symptoms in menopausal women.
Menopause is characterized by the cessation of menstruation for 12 consecutive months. It is a natural phase in which a women's menstrual cycles permanently cease, with the transition often beginning around 50 years of age or older. Menopausal women often experience changes in vaginal health and sexuality, loss of bladder control, changes in mood, decreased sleep quality, changes in body composition, and vasomotor symptoms (VMS, including hot flashes and night sweats). VMS can have a negative impact on quality of life by disrupting both sleep and mood. Some management strategies for VMS include hypnosis, and supplementation of vitamin E, black cohosh, and phytoestrogens. However, hormone replacement therapy still remains the most common and effective treatment. Hormone replacement therapy, using estrogen or estrogen-progestin containing products, reduces the frequency and severity of hot flashes by 75-79%. Although hormone replacement therapy is generally well tolerated, it has been linked to an increased risk of breast cancer. Due to this concern it is recommended to use hormone replacement therapy for the shortest duration and lowest dose possible. There is a need for alternative options to help manage VMS in menopausal women, and dietary supplements may fill this role. The test product (TP) for this study is a dietary supplement containing a proprietary botanical blend containing polyphenols and flavonoids. These herbal ingredients have been previously investigated for various properties, which demonstrate the opportunity to support the quality of life of menopausal women experiencing VMS by improving sleep and mood. This randomized, double-blind, placebo-controlled, parallel study will be conducted to evaluate the TP for its impacts on healthy menopausal women with VMS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
74
Take 2 capsules once daily in the mornings with food
Take 2 capsules once daily in the mornings with food
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Altus Research
Lake Worth, Florida, United States
Rosemark WomenCare
Idaho Falls, Idaho, United States
To determine the effects of the Test Product (TP) compared to placebo on hot flash symptoms as determined by the Hot Flash Related Daily Interference Scale (HFRDIS).
Change from baseline for the number and severity of hot flashes measured by HFRDIS scores. The HFRDIS has a scoring range of 0-100, with higher values indicating worse symptoms.
Time frame: 12 weeks
To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Greene Climacteric Scale (GCS).
Change from baseline in GCS scores. The GCS has 3 sub-domains for scoring. The psychological sub-domain has a scoring range from 0-33, the physical sub-domain has a scoring range from 0-21, and the vasomotor sub-domain has a scoring range from 0-6. Higher values indicate worse symptoms in all 3 sub-domains.
Time frame: 12 weeks
To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Menopausal Rating Scale (MRS).
Change from baseline in MRS scores. The MRS has a scoring range of 0-44, with higher values indicating worse symptoms.
Time frame: 12 weeks
To determine the effect of the TP compared to the placebo on sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).
Change from baseline in PSQI scores. The PSQI has a scoring range of 0-21, with higher values indicating worse symptoms.
Time frame: 12 weeks
To determine the effect of the TP compared to the placebo on quality of life as determined by the Menopause-Specific Quality of Life (MENQOL) questionnaire.
Change from baseline in MENQOL scores. The MRS has a scoring range of 0-174, with higher values indicating worse symptoms.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.