JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-70
SponsorBonafide Health

About this trial

The goal of this interventional study is to evaluate whether the study product can help improve quality of life and reduce common menopause symptoms-such as joint discomfort, hot flashes and night sweats-in women aged 50-70. The primary research question is whether taking the study product daily for 12 weeks can reduce the severity and frequency of menopause-related symptoms.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy biological females who are 50-70 years of age (inclusive).

Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).

Self-reported as postmenopause. Defined as 12 months without a menstrual cycle in individuals who undergo "Natural" Menopause (Not Surgically or medically induced) and who have self-reported menopausal outcomes for the past 6 months.

Have self-reported menopause related joint outcomes of moderate or severe severity according to a perceived discomfort greater or equal to 5 and less than 10 on a scale of 0-10 (participants rating their discomfort 5-9 will be included).

Disqualifiers

Individuals who are lactating, pregnant, or planning to become pregnant during the study.

Active participation in a clinical trial.

Use of any treatment for menopausal outcomes or other concomitant treatments for menopausal symptoms, joint health or at the discretion of the investigator. (Participants may be deemed ineligible at the discretion of the investigator if the medication may cause adverse interaction.)

Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JDS-HF3.0

    Dietary supplement

    Active Supplement JDS-HF3.0

  • Placebo

    Other intervention

    Nonactive Placebo

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: JDS-HF3.0 Active GroupActive comparator 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Menopause Related Quality of Life Outcomes

Change from baseline in scores for severity of perceived joint discomfort, frequency of perceived joint discomfort, perceived joint mobility and perceived daily mobility assessed via a Visual Analog Scale (VAS). Response options will range from 0-100, with a higher score reflecting the worse outcome.

Time frame
From enrollment to the end of study at 12 weeks
2

Change from Baseline in Menopause Related Quality of Life Outcomes

Change from baseline in scores for Arthralgia Inventory (PRAI) score. The rating scale ranges from 0-10, with a higher score indicating a worse outcome.

Time frame
From enrollment to the end of study at 12 weeks
3

Change from Baseline in Menopause Related Quality of Life Outcomes

Change from baseline in scores for Musculoskeletal Health Questionnaire (MSK-HQ) score. Each response ranges from "not at all" to "very severe", with a higher score indicating a better outcome.

Time frame
From enrollment to the end of study at 12 weeks

Secondary outcomes

1

Change from Baseline on Overall Menopausal Symptoms

Change from baseline in scores for the following: Menopause Specific Quality of Life Questionnaire (MENQOL). Each question being scored from 0 to 6, with 6 being the worse outcome.

Time frame
From enrollment to the end of study at 12 weeks
2

Change from Baseline on Overall Menopausal Symptoms

Change from baseline in scores for Menopausal Rating Scale (MRS).Each question is rated on a 5-point scale with the higher number correlating with the more severe symptoms and worse outcome.

Time frame
From enrollment to the end of study at 12 weeks
3

Change from Baseline on Overall Menopausal Symptoms

Change from baseline in the frequency of menopause related hot flashes assessed via daily diaries. Daily diaries include the number of total vasomotor occurrences, the severity of total vasomotor occurrences and the number of times awoke during the night due to night sweat occurrences.

Time frame
From enrollment to the end of study at 12 weeks

Other outcomes

1

Reports of Adverse Events

Assess the safety and tolerability of the study product in healthy participants

Time frame
From baseline to the end of study at 12 weeks

Sponsors and contacts

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