Effect of Fenugreek Fibre on Gut Microbiome
- Conditions
- Gut Microbiome
- Interventions
- Drug: Fenugreek Fibre
- Registration Number
- NCT06006416
- Lead Sponsor
- RDC Clinical Pty Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fenugreek Fibre Fenugreek Fibre Fenugreek Fibre - 2 x 10g powder per day with/in food
- Primary Outcome Measures
Name Time Method Change in metagenomic profile of the gut microbiome Week 0, week 4 and week 16 Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing
- Secondary Outcome Measures
Name Time Method Change in safety Week 0, week 4 and week 16 Change in safety as measured by E/LFT via blood test
Change in gut function Week 0, week 4 and week 16 Change in gut function as measured by faecal short change fatty acids testing via faecal sample
Change in GST Week, 0, week 4, week 8 and week 16 Change in GST as measured by blood test
Height Week 0, week 4 and week 16 Height as measured by stadiometer
Change in hip and weight circumference Week 0, week 4 and week 16 Change in hip and weight circumference as measured by tape measure
Change in blood pressure Week 0, week 4 and week 16 Change in blood pressure as measured by blood pressure monitor
Change in inflammation Week, 0, week 4, week 8 and week 16 Change in inflammation as measured by inflammatory markers (IFN-g, TNF-a, il-2, MCP-2, IL-1b, TGF-b, CRP) via blood test
Change in GLP-1 Week, 0, week 4, week 8 and week 16 Change in GLP-1 as measured by blood test
Change in glutathione Week, 0, week 4, week 8 and week 16 Change in glutathione as measured by blood test
Change in stress state Week, 0, week 4, week 8 and week 16 Change in stress as measured by the Perceived Stress Scale questionnaire. Consists of 10 items with a score range 0-40. Higher scores indicate higher perceived stress.
Change in gut inflammation Week 0, week 4 and week 16 Change in gut inflammation as measured by faecal calprotectin via faecal sample
Change in Homocysteine Week, 0, week 4, week 8 and week 16 Change in Homocysteine as measured by blood test
Change in quality of life Week, 0, week 4, week 8 and week 16 Change in quality of life as measured by the SF-36 questionnaire. Consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Change in weight Week 0, week 4 and week 16 Change in weight as measured by digital scale
Change in intestinal permeability Week, 0, week 4, week 8 and week 16 Change in intestinal permeability as measured by plasma occludin, Muc2 and Endotoxin via blood test
Change in FABP Week, 0, week 4, week 8 and week 16 Change in FABP as measured by blood test
Change in diet Week 0 and Week 16 (completed for 3 consecutive days) Change in diet as measured by 24hr Dietary Recall
Change in sleep quality Week, 0, week 4, week 8 and week 16 Change in sleep as measured by the Leeds Sleep Evaluation Questionnaire. Consists of ten questions pertaining to four consecutive aspects of sleep: getting to sleep (GTS), quality of sleep (QOS), awakening from sleep (AFS), and behaviour following wakefulness (BFW). Higher scores indicate better sleep quality.
Trial Locations
- Locations (1)
RDC Global Pty Ltd
🇦🇺Brisbane, Queensland, Australia