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

NCT07238478 | Recruiting

• 2 other identifiers: BH-TJP-BT-00113364-TAVanDusseldorp
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Joint Discomfort; Joint Pain, Stiffness, Function; Joint Pain; Hot Flashes; Hot Flash; Night Sweats; Vasomotor Symptoms

Keywords

Postmenopausal; Post menopause; Vasomotor Symptoms; Night sweats; Hot Flashes; Joint Pain; Joint Discomfort; Non-hormonal Treatment; Supplement

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to the end of study at 12 weeks

• 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.

  From enrollment to the end of study at 12 weeks

• 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.

  From enrollment to the end of study at 12 weeks

Secondary Outcomes (3)

• Change from Baseline on Overall Menopausal Symptoms

  From enrollment to the end of study at 12 weeks

• Change from Baseline on Overall Menopausal Symptoms

  From enrollment to the end of study at 12 weeks

• Change from Baseline on Overall Menopausal Symptoms

  From enrollment to the end of study at 12 weeks

Other Outcomes (1)

• Reports of Adverse Events

  From baseline to the end of study at 12 weeks

Study Arms (2)

JDS-HF3.0 Active Group

ACTIVE COMPARATOR

Group of participants supplementing with JDS-HF3.0

Dietary Supplement: JDS-HF3.0

Placebo Comparator

PLACEBO COMPARATOR

Group consuming nonactive placebo

Other: Placebo

Interventions

JDS-HF3.0 DIETARY_SUPPLEMENT

Active Supplement JDS-HF3.0

JDS-HF3.0 Active Group

Placebo OTHER

Nonactive Placebo

Placebo Comparator

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: Cisgender Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Have self-reported \> or equal to 4 hot flashes on average per day.
• In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
• Agree to refrain from treatments listed in Section 6.5 in the defined timeframe.
• Have reliable, stable access to Wi-Fi and a smart phone/device.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read questionnaires, and carry out all study-related procedures.

You may not qualify if:

• 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.
• Use of Glucosamine and/or Chondroitin for joint outcomes in the last 3 months prior to screening.
• Received a COVID-19 vaccine in the 2 weeks prior to screening or during the study period, current COVID-19 infections or currently have the post-COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
• Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV).
• History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.
• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.
• History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, gastric bypass procedures, or pancreatic insufficiency).
• Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
• Major surgery in three months prior to screening or planned major surgery during the study.
• History of alcohol or substance abuse in the last 5 years.
• Has evidence of inflammatory rheumatic disease or other diagnosed anti-inflammatory disease.
• Has evidence of autoimmune disease(s).

Sponsors & Collaborators

• Bonafide Health: lead

Study Sites (1)

Bonafide Health

Harrison, New York, 10528, United States

RECRUITING

Related Publications (14)

• Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.

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• Shep D, Khanwelkar C, Gade P, Karad S. Efficacy and safety of combination of curcuminoid complex and diclofenac versus diclofenac in knee osteoarthritis: A randomized trial. Medicine (Baltimore). 2020 Apr;99(16):e19723. doi: 10.1097/MD.0000000000019723.

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• Shep D, Khanwelkar C, Gade P, Karad S. Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study. Trials. 2019 Apr 11;20(1):214. doi: 10.1186/s13063-019-3327-2.

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• Kumar N, Singh S, Patro N, Patro I. Evaluation of protective efficacy of Spirulina platensis against collagen-induced arthritis in rats. Inflammopharmacology. 2009 Jun;17(3):181-90. doi: 10.1007/s10787-009-0004-1. Epub 2009 Apr 24.

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• Dillon JC, Phuc AP, Dubacq JP. Nutritional value of the alga Spirulina. World Rev Nutr Diet. 1995;77:32-46. doi: 10.1159/000424464. No abstract available.

  PMID: 7732699 BACKGROUND

• Castel LD, Wallston KA, Saville BR, Alvarez JR, Shields BD, Feurer ID, Cella D. Validity and reliability of the Patient-Reported Arthralgia Inventory: validation of a newly-developed survey instrument to measure arthralgia. Patient Relat Outcome Meas. 2015 Jul 28;6:205-14. doi: 10.2147/PROM.S47997. eCollection 2015.

  PMID: 26251635 BACKGROUND

• Magni A, Agostoni P, Bonezzi C, Massazza G, Mene P, Savarino V, Fornasari D. Management of Osteoarthritis: Expert Opinion on NSAIDs. Pain Ther. 2021 Dec;10(2):783-808. doi: 10.1007/s40122-021-00260-1. Epub 2021 Apr 19.

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• Suhail M, Rehan M, Tarique M, Tabrez S, Husain A, Zughaibi TA. Targeting a transcription factor NF-kappaB by green tea catechins using in silico and in vitro studies in pancreatic cancer. Front Nutr. 2023 Jan 11;9:1078642. doi: 10.3389/fnut.2022.1078642. eCollection 2022.

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• Ahmed S. Green tea polyphenol epigallocatechin 3-gallate in arthritis: progress and promise. Arthritis Res Ther. 2010;12(2):208. doi: 10.1186/ar2982. Epub 2010 Apr 28.

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• Zaratin P, Angelici O, Clarke GD, Schmid G, Raiteri M, Carita F, Bonanno G. NK3 receptor blockade prevents hyperalgesia and the associated spinal cord substance P release in monoarthritic rats. Neuropharmacology. 2000;39(1):141-9. doi: 10.1016/s0028-3908(99)00087-8.

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• Barbalho S. M., Goulart R. D. A, Buglio D. S., Araujo A. C., Guiguer E. L. The possible role of green tea on osteoarthritis: a narrative report. Longhua Chin Med 2020;3:11.

  BACKGROUND

• Strand NH, D'Souza RS, Gomez DA, Whitney MA, Attanti S, Anderson MA, Moeschler SM, Chadwick AL, Maloney JA. Pain during menopause. Maturitas. 2025 Jan;191:108135. doi: 10.1016/j.maturitas.2024.108135. Epub 2024 Oct 31.

  PMID: 39500125 BACKGROUND

• Magliano M. Menopausal arthralgia: Fact or fiction. Maturitas. 2010 Sep;67(1):29-33. doi: 10.1016/j.maturitas.2010.04.009.

  PMID: 20537472 BACKGROUND

• Blumer J. Arthralgia of menopause - A retrospective review. Post Reprod Health. 2023 Jun;29(2):95-97. doi: 10.1177/20533691231172565. Epub 2023 May 1.

  PMID: 37127408 BACKGROUND

Related Links

• Epigallocatechin-3-gallate (EGCG): Chemical and biomedical perspectives
• Corticosteroid Adverse Effects
• Green tea polyphenol epigallocatechin 3-gallate in arthritis: progress and promise.
• Measurement properties of the musculoskeletal health questionnaire (MSK-HQ): a between country comparison
• The potential application of Spirulina (Arthrospora) as a nutritional and therapeutic supplement in health management

MeSH Terms

Conditions

Arthralgia; Hot Flashes

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Trisha VanDusseldorp, PhD

CONTACT

233-266-2343; tvandusseldorp@bonafidehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: November 20, 2025
• Study Start: May 14, 2025
• Primary Completion: July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)