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

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

Overview

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.

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.

Interventions

• Dietary supplement JDS-HF3.0
  Active Supplement JDS-HF3.0
• Other Placebo
  Nonactive Placebo

Primary outcome measures

• Change from Baseline in Menopause Related Quality of Life Outcomes [Time frame: From enrollment to the end of study at 12 weeks]
• Change from Baseline in Menopause Related Quality of Life Outcomes [Time frame: From enrollment to the end of study at 12 weeks]
• Change from Baseline in Menopause Related Quality of Life Outcomes [Time frame: From enrollment to the end of study at 12 weeks]

Secondary outcome measures (3)

• Change from Baseline on Overall Menopausal Symptoms [Time frame: From enrollment to the end of study at 12 weeks]
• Change from Baseline on Overall Menopausal Symptoms [Time frame: From enrollment to the end of study at 12 weeks]
• Change from Baseline on Overall Menopausal Symptoms [Time frame: From enrollment to the end of study at 12 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Bonafide Health — Harrison

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 36712528

Identifiers

NCT: NCT07238478 · BH-TJP-BT-001 · 13364-TAVanDusseldorp

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗