Effect of Fenugreek Fibre on Gut Microbiome

NCT06006416 | Withdrawn Phase 3

• 1 other identifier: FENGUT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change in metagenomic profile of the gut microbiome

  Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing

  Week 0, week 4 and week 16

Secondary Outcomes (18)

• Change in gut function

  Week 0, week 4 and week 16

• Change in intestinal permeability

  Week, 0, week 4, week 8 and week 16

• Change in gut inflammation

  Week 0, week 4 and week 16

• Change in inflammation

  Week, 0, week 4, week 8 and week 16

• Change in GLP-1

  Week, 0, week 4, week 8 and week 16

Study Arms (1)

Fenugreek Fibre

EXPERIMENTAL

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

Drug: Fenugreek Fibre

Interventions

Fenugreek Fibre DRUG

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

Fenugreek Fibre

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).
• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Officials

• Amanda Rao, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 23, 2023
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share