Effect of Fenugreek Fibre on Gut Microbiome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fenugreek Fibre Fenugreek Fibre - 2 x 10g powder per day with/in food |
Drug: Fenugreek Fibre
Daily dose of 2 x 10g per day with/in food
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 gut inflammation [Week 0, week 4 and week 16]
Change in gut inflammation as measured by faecal calprotectin via faecal sample
- 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 GST [Week, 0, week 4, week 8 and week 16]
Change in GST 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 FABP [Week, 0, week 4, week 8 and week 16]
Change in FABP as measured by blood test
- Change in Homocysteine [Week, 0, week 4, week 8 and week 16]
Change in Homocysteine 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 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 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 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.
- Change in safety [Week 0, week 4 and week 16]
Change in safety as measured by E/LFT via blood test
- Height [Week 0, week 4 and week 16]
Height as measured by stadiometer
- Change in weight [Week 0, week 4 and week 16]
Change in weight as measured by digital scale
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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
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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.
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Active smokers and/or nicotine or drug abuse
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Chronic alcohol use (>14 alcoholic drinks week)
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Allergic to any of the ingredients in the formula
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Pregnant(2) or lactating woman
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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).
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Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
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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.
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | RDC Global Pty Ltd | Brisbane | Queensland | Australia | 4006 |
Sponsors and Collaborators
- RDC Clinical Pty Ltd
Investigators
- Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FENGUT