Gut Microbiome
Conditions
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.
Interventions
DRUGFenugreek Fibre
Daily dose of 2 x 10g per day with/in food
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 * 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 1. 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. 2. All female participants of child bearing potential will be required to take a urine pregnancy test prior to entry into the study. 3. 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 4. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 safety | Week 0, week 4 and week 16 | Change in safety as measured by E/LFT via 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 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 GLP-1 | Week, 0, week 4, week 8 and week 16 | Change in GLP-1 as measured by blood test |
Outcome results
None listed