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Joint DiscomfortNCT07238478

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

A study testing JDS-HF3.0 in people with Joint Discomfort and Joint Pain, Stiffness, Function, run by Bonafide Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
What is being tested?
JDS-HF3.0
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
1 siteUnited States
Study dates
14 May 2025to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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).
  • 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.
  • 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.
  • Have severe joint and/or severe bone deformities.
  • Diagnosed bone fractures.
  • Are a candidate for surgical joint replacement.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Trisha VanDusseldorp, PhD contact

233-266-2343

tvandusseldorp@bonafidehealth.com

United States1 site, 1 recruiting
  • Bonafide Health

    Harrison, New York, 10528

    Trisha VanDusseldorp, PhD, 233-266-2343, tvandusseldorp@bonafidehealth.com

    Trisha VanDusseldorp, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
JDS-HF3.0, Placebo
Keywords
Postmenopausal, Post menopause, Vasomotor Symptoms, Night sweats, Hot Flashes, Joint Pain, Joint Discomfort, Non-hormonal Treatment, Supplement
Medical subject headings
Arthralgia, Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JDS-HF3.0Dietary supplement

    Active Supplement JDS-HF3.0

  • PlaceboOther

    Nonactive Placebo

Study groups in NCT07238478
Study groupRoleWhat they receive
JDS-HF3.0 Active GroupActive comparatorGroup of participants supplementing with JDS-HF3.0
Receives: Dietary Supplement: JDS-HF3.0
Placebo ComparatorPlacebo comparatorGroup consuming nonactive placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: From enrollment to the end of study at 12 weeks

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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.

    Measured: From enrollment to the end of study at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start14 May 2025
  3. Primary completionJul 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07238478
Sponsor's protocol ID
BH-TJP-BT-001
Other IDs
13364-TAVanDusseldorp
Status last verified
Nov 2025
First submitted
6 May 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be privately owned.

Publications

  • 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.

    PubMed 15345062
  • 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.

    PubMed 32311961
  • 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.

    PubMed 30975196
  • 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.

    PubMed 19390977
  • 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.

    PubMed 7732699
  • 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.

    PubMed 26251635
  • 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.

    PubMed 33876393
  • 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.

    PubMed 36712528
  • 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.

    PubMed 20447316
  • 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.

    PubMed 10665827
  • 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.

    PubMed 39500125
  • Magliano M. Menopausal arthralgia: Fact or fiction. Maturitas. 2010 Sep;67(1):29-33. doi: 10.1016/j.maturitas.2010.04.009.

    PubMed 20537472
  • 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.

    PubMed 37127408

Questions about this trial

What is this clinical trial studying?

A study testing JDS-HF3.0 in people with Joint Discomfort and Joint Pain, Stiffness, Function, run by Bonafide Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trisha VanDusseldorp, PhD (233-266-2343, tvandusseldorp@bonafidehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Menopause Related Quality of Life Outcomes (time frame: From enrollment to the end of study at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07238478, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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