Status:
WITHDRAWN
Effect of Fenugreek Fibre on Gut Microbiome
Lead Sponsor:
RDC Clinical Pty Ltd
Conditions:
Gut Microbiome
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A open label, self-controlled trial to evaluate the effect of Fenugreek Fibre (Trigonella foenum-graecum) on the gut microbiome in generally healthy adults aged 18-65 years old.
Eligibility Criteria
Inclusion
- Male and females aged 18-65 years old
- Generally healthy
- Able to provide informed consent
- BMI \> 25kg/m2
- Agree not to participate in another clinical trial while enrolled in this trial
- Agree not the change their diet or exercise while enrolled in this trial
Exclusion
- Unstable(1) or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma and mood disorders or neurological disorders such as MS)
- Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
- Acute sickness experienced within the past 2 months
- Current use of medications (e.g. antibiotics) or supplements (e.g. pre- and probiotics) that alter the microbiome or gut health. Any use during the trial will result in exclusion from the study.
- Active smokers and/or nicotine or drug abuse
- Chronic alcohol use (\>14 alcoholic drinks week)
- Allergic to any of the ingredients in the formula
- Pregnant(2) or lactating woman
- Females of child bearing potential not using a highly effective form of contraception(3,4) (i.e. methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly like the oral contraception pill, birth control implant e.g. implanon(3,4))
- People medically prescribed medications that would affect the immune and/or the inflammatory response (e.g. NSAIDs, steroids, antibiotics).
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- Participants who have participated in any other related clinical study during the past 1 month
- People with cognitive damage
- People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year
- Footnotes
- An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- All female participants of child bearing potential will be required to take a urine pregnancy test prior to entry into the study.
- Examples of acceptable forms of highly effective contraception include: Established use of oral, injected or implanted hormonal methods of contraception; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); True abstinence: When this is in line with your preferred and usual lifestyle
- Examples of non-acceptable methods of contraception include: Condoms alone or double barrier; Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation); Withdrawal; Spermicide (as it is not approved as a method of contraception in Australia)
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06006416
Start Date
December 1 2024
End Date
September 1 2025
Last Update
October 21 2024
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