JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women
NCT ID: NCT07238478
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2025-05-14
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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JDS-HF3.0 Active Group
Group of participants supplementing with JDS-HF3.0
JDS-HF3.0
Active Supplement JDS-HF3.0
Placebo Comparator
Group consuming nonactive placebo
Placebo
Nonactive Placebo
Interventions
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JDS-HF3.0
Active Supplement JDS-HF3.0
Placebo
Nonactive Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
70 Years
FEMALE
Yes
Sponsors
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Bonafide Health
INDUSTRY
Responsible Party
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Locations
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Bonafide Health
Harrison, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
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13364-TAVanDusseldorp
Identifier Type: OTHER
Identifier Source: secondary_id
BH-TJP-BT-001
Identifier Type: -
Identifier Source: org_study_id
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