Effect of Fenugreek Fibre on Gut Microbiome

NCT ID: NCT06006416

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-09-01

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.

Conditions

Gut Microbiome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fenugreek Fibre

Fenugreek Fibre - 2 x 10g powder per day with/in food

Group Type: EXPERIMENTAL

Fenugreek Fibre

Intervention Type: DRUG

Daily dose of 2 x 10g per day with/in food

Interventions

Fenugreek Fibre

Daily dose of 2 x 10g per day with/in food

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RDC Clinical Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Rao, PhD

Role: PRINCIPAL_INVESTIGATOR

RDC Clinical Pty Ltd

Other Identifiers

FENGUT

Identifier Type: -

Identifier Source: org_study_id