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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06006416
Registration number
NCT06006416
Ethics application status
Date submitted
1/08/2023
Date registered
23/08/2023
Titles & IDs
Public title
Effect of Fenugreek Fibre on Gut Microbiome
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Scientific title
Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - An Open Label, Self-controlled Trial
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Secondary ID [1]
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FENGUT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gut Microbiome
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in metagenomic profile of the gut microbiome
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Assessment method [1]
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Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing
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Timepoint [1]
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Week 0, week 4 and week 16
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Secondary outcome [1]
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Change in gut function
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Assessment method [1]
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Change in gut function as measured by faecal short change fatty acids testing via faecal sample
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Timepoint [1]
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Week 0, week 4 and week 16
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Secondary outcome [2]
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Change in intestinal permeability
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Assessment method [2]
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Change in intestinal permeability as measured by plasma occludin, Muc2 and Endotoxin via blood test
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Timepoint [2]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [3]
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Change in gut inflammation
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Assessment method [3]
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Change in gut inflammation as measured by faecal calprotectin via faecal sample
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Timepoint [3]
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Week 0, week 4 and week 16
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Secondary outcome [4]
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Change in inflammation
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Assessment method [4]
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Change in inflammation as measured by inflammatory markers (IFN-g, TNF-a, il-2, MCP-2, IL-1b, TGF-b, CRP) via blood test
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Timepoint [4]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [5]
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Change in GLP-1
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Assessment method [5]
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Change in GLP-1 as measured by blood test
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Timepoint [5]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [6]
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Change in GST
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Assessment method [6]
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Change in GST as measured by blood test
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Timepoint [6]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [7]
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Change in glutathione
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Assessment method [7]
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Change in glutathione as measured by blood test
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Timepoint [7]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [8]
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Change in FABP
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Assessment method [8]
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Change in FABP as measured by blood test
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Timepoint [8]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [9]
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Change in Homocysteine
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Assessment method [9]
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Change in Homocysteine as measured by blood test
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Timepoint [9]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [10]
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Change in diet
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Assessment method [10]
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Change in diet as measured by 24hr Dietary Recall
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Timepoint [10]
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Week 0 and Week 16 (completed for 3 consecutive days)
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Secondary outcome [11]
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Change in quality of life
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Assessment method [11]
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Change in quality of life as measured by the SF-36 questionnaire. Consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
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Timepoint [11]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [12]
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Change in stress state
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Assessment method [12]
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Change in stress as measured by the Perceived Stress Scale questionnaire. Consists of 10 items with a score range 0-40. Higher scores indicate higher perceived stress.
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Timepoint [12]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [13]
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Change in sleep quality
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Assessment method [13]
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Change in sleep as measured by the Leeds Sleep Evaluation Questionnaire. Consists of ten questions pertaining to four consecutive aspects of sleep: getting to sleep (GTS), quality of sleep (QOS), awakening from sleep (AFS), and behaviour following wakefulness (BFW). Higher scores indicate better sleep quality.
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Timepoint [13]
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Week, 0, week 4, week 8 and week 16
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Secondary outcome [14]
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Change in safety
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Assessment method [14]
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Change in safety as measured by E/LFT via blood test
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Timepoint [14]
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Week 0, week 4 and week 16
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Secondary outcome [15]
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Height
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Assessment method [15]
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Height as measured by stadiometer
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Timepoint [15]
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Week 0, week 4 and week 16
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Secondary outcome [16]
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Change in weight
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Assessment method [16]
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Change in weight as measured by digital scale
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Timepoint [16]
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Week 0, week 4 and week 16
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Secondary outcome [17]
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Change in hip and weight circumference
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Assessment method [17]
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Change in hip and weight circumference as measured by tape measure
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Timepoint [17]
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Week 0, week 4 and week 16
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Secondary outcome [18]
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Change in blood pressure
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Assessment method [18]
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Change in blood pressure as measured by blood pressure monitor
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Timepoint [18]
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Week 0, week 4 and week 16
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/09/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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RDC Global Pty Ltd - Brisbane
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
RDC Clinical Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06006416
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Amanda Rao, PhD
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Address
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RDC Clinical Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06006416