NCT05813067

Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women

The Effects of JDS-HF3.0 on Vasomotor Symptoms in Menopausal Women: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Bonafide Health · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Vasomotor Symptoms
• Postmenopausal Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	JDS-HF 3.0	Take 2 capsules once daily in the mornings with food
DIETARY_SUPPLEMENT	Placebo	Take 2 capsules once daily in the mornings with food

Timeline

• Start date: 2022-12-27
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2023-04-14
• Last updated: 2024-06-26

Locations

3 sites across 1 country: United States