Effect of Fenugreek Fibre on Gut Microbiome

RDC Clinical

Status and phase

Withdrawn

Phase 3

Conditions

Gut Microbiome

Treatments

Drug: Fenugreek Fibre

Study type

Interventional

Funder types

Industry

Identifiers

NCT06006416

FENGUT

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

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)