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

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of JDS-HF3.0 in Menopause Related Quality of Life Outcomes in Postmenopausal Women

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.

Study Overview

• Status: Recruiting
• Conditions: Joint Pain; Vasomotor Symptoms; Hot Flashes; Joint Discomfort; Joint Pain, Stiffness, Function; Night Sweats; Hot Flash
• Intervention / Treatment: Dietary supplement: JDS-HF3.0; Other: Placebo

Detailed Description

About 250 women across the U.S. will take part in this study. Participants will be randomly placed into one of two groups-one will take the active study product, and the other will take a placebo. All participants will take two tablets each morning for about 12 weeks. The total time the participant will be in the study is about 14 weeks, including the time it takes to collect baseline values.

All parts of the study are done virtually, in-person visits are not required. The participant will take part in five virtual check-ins, including a screening visit, a baseline visit, two check-ins during the study, and a final visit at the end. Throughout the study, the participant will be asked to complete daily diaries and weekly and monthly questionnaires to report on their symptoms and how they are feeling. These will include questions about hot flashes, night sweats, physical comfort, and overall well-being. The study is led by a research team based in Harrison, NY, USA.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trisha VanDusseldorp, PhD; Phone Number: 233-266-2343; Email: tvandusseldorp@bonafidehealth.com

Study Locations

• United States
  • New York
    • Harrison, New York, United States, 10528
      • Recruiting
      • Bonafide Health
      • Contact: Trisha VanDusseldorp, PhD; Phone Number: 233-266-2343; Email: tvandusseldorp@bonafidehealth.com
      • Principal Investigator: Trisha VanDusseldorp, PhD
      • Sub-Investigator: Austin Lamothe
      • Sub-Investigator: Michaela Alesi
      • Sub-Investigator: Laura Mason
      • Sub-Investigator: Stephen Carbonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy biological females who are 50-70 years of age (inclusive).
2. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
3. 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.
4. 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).
5. Have self-reported > or equal to 4 hot flashes on average per day.
6. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
7. Agree to refrain from treatments listed in Section 6.5 in the defined timeframe.
8. Have reliable, stable access to Wi-Fi and a smart phone/device.
9. 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.

Exclusion Criteria:

1. Individuals who are lactating, pregnant, or planning to become pregnant during the study.
2. Active participation in a clinical trial.
3. 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.)
4. Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.
5. Use of Glucosamine and/or Chondroitin for joint outcomes in the last 3 months prior to screening.
6. 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).
7. Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV).
8. History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.
9. 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.
10. 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).
11. 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).
12. Major surgery in three months prior to screening or planned major surgery during the study.
13. History of alcohol or substance abuse in the last 5 years.
14. Has evidence of inflammatory rheumatic disease or other diagnosed anti-inflammatory disease.
15. Has evidence of autoimmune disease(s).
16. Chronic use of curcumin or curcuminoids in an herbal or dietary supplement. Note: Screened participants that are willing to undergo a washout period of at least 3 months prior to participation in the trial can be enrolled.
17. Chronic pain medication and use of analgesics specifically for joint-related discomfort (i.e. Opiates, Tramadol) Note: Screened participants that are willing to undergo a washout period of at least 2 weeks during the duration of the trial can be enrolled.
18. Have severe joint and/or severe bone deformities.
19. Diagnosed bone fractures.
20. Are a candidate for surgical joint replacement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: JDS-HF3.0 Active Group; Group of participants supplementing with JDS-HF3.0	Dietary supplement: JDS-HF3.0; Active Supplement JDS-HF3.0
Placebo Comparator: Placebo Comparator; Group consuming nonactive placebo	Other: Placebo; Nonactive Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of study at 12 weeks
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.	From enrollment to the end of study at 12 weeks
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.	From enrollment to the end of study at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reports of Adverse Events	Assess the safety and tolerability of the study product in healthy participants	From baseline to the end of study at 12 weeks

Collaborators and Investigators

• Sponsor: Bonafide Health

Publications and helpful links

General Publications

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

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 6, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Postmenopausal; Vasomotor Symptoms; Hot Flashes; Joint Pain; Supplement; Joint Discomfort; Post menopause; Night sweats; Non-hormonal Treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arthralgia; Hot Flashes
• Other Study ID Numbers: BH-TJP-BT-001; 13364-TAVanDusseldorp (Other Identifier: Sterling IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be privately owned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No