Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06006416




Registration number
NCT06006416
Ethics application status
Date submitted
1/08/2023
Date registered
23/08/2023
Date last updated
18/11/2023

Titles & IDs
Public title
Effect of Fenugreek Fibre on Gut Microbiome
Scientific title
Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - An Open Label, Self-controlled Trial
Secondary ID [1] 0 0
FENGUT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut Microbiome 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fenugreek Fibre

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


Treatment: Drugs: Fenugreek Fibre
Daily dose of 2 x 10g per day with/in food
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in metagenomic profile of the gut microbiome
Timepoint [1] 0 0
Week 0, week 4 and week 16
Secondary outcome [1] 0 0
Change in gut function
Timepoint [1] 0 0
Week 0, week 4 and week 16
Secondary outcome [2] 0 0
Change in intestinal permeability
Timepoint [2] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [3] 0 0
Change in gut inflammation
Timepoint [3] 0 0
Week 0, week 4 and week 16
Secondary outcome [4] 0 0
Change in inflammation
Timepoint [4] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [5] 0 0
Change in GLP-1
Timepoint [5] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [6] 0 0
Change in GST
Timepoint [6] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [7] 0 0
Change in glutathione
Timepoint [7] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [8] 0 0
Change in FABP
Timepoint [8] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [9] 0 0
Change in Homocysteine
Timepoint [9] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [10] 0 0
Change in diet
Timepoint [10] 0 0
Week 0 and Week 16 (completed for 3 consecutive days)
Secondary outcome [11] 0 0
Change in quality of life
Timepoint [11] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [12] 0 0
Change in stress state
Timepoint [12] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [13] 0 0
Change in sleep quality
Timepoint [13] 0 0
Week, 0, week 4, week 8 and week 16
Secondary outcome [14] 0 0
Change in safety
Timepoint [14] 0 0
Week 0, week 4 and week 16
Secondary outcome [15] 0 0
Height
Timepoint [15] 0 0
Week 0, week 4 and week 16
Secondary outcome [16] 0 0
Change in weight
Timepoint [16] 0 0
Week 0, week 4 and week 16
Secondary outcome [17] 0 0
Change in hip and weight circumference
Timepoint [17] 0 0
Week 0, week 4 and week 16
Secondary outcome [18] 0 0
Change in blood pressure
Timepoint [18] 0 0
Week 0, week 4 and week 16

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Global Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06006416
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06006416