Clinical trial NCT06006416: Effect of Fenugreek Fibre on Gut Microbiome
Official title: Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - an Open Label, Self-controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gut Microbiome
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Change in metagenomic profile of the gut microbiome
timeFrame: Week 0, week 4 and week 16
Secondary outcomes:
measure: Change in gut function
timeFrame: Week 0, week 4 and week 16
measure: Change in intestinal permeability
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in gut inflammation
timeFrame: Week 0, week 4 and week 16
measure: Change in inflammation
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in GLP-1
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in GST
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in glutathione
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in FABP
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in Homocysteine
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in diet
timeFrame: Week 0 and Week 16 (completed for 3 consecutive days)
measure: Change in quality of life
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in stress state
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in sleep quality
timeFrame: Week, 0, week 4, week 8 and week 16
measure: Change in safety
timeFrame: Week 0, week 4 and week 16
measure: Height
timeFrame: Week 0, week 4 and week 16
measure: Change in weight
timeFrame: Week 0, week 4 and week 16
measure: Change in hip and weight circumference
timeFrame: Week 0, week 4 and week 16
measure: Change in blood pressure
timeFrame: Week 0, week 4 and week 16
Other outcomes:
Locations:
Study officials:
affiliation: RDC Clinical Pty Ltd
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: