Study to Investigate the Effect of Dietary Fibre Supplementation on Long-term Glucose Control in Prediabetic Subjects
NCT ID: NCT05157815
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
46 participants
INTERVENTIONAL
2021-10-04
2023-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The hypothesis is that twice daily supplementation with Soluble Fibre over a period of 16 weeks will significantly improve long term glucose control in pre-diabetic participants.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Soluble Corn Fibre
12g compound per Sachet (providing 10g fibre) consumed twice per day
Soluble Fibre
10g soluble corn fibre to be consumed twice per day
Maltodextrin
Calorie matched control of 2 g compound per sachet (0 g fibre), composed of: Maltodextrin, consumed twice per day
Calorie Matched Control
2g maltodextrin consumed twice per day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Soluble Fibre
10g soluble corn fibre to be consumed twice per day
Calorie Matched Control
2g maltodextrin consumed twice per day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Males \& females aged 18 to 70 years (inclusive).
3. Has a BMI between ≥30 and ≤40 kg/m2.
4. HbA1c between ≥38.8 and ≤47 mmol/mol (5.7-6.4 %)
5. Has a stable body weight (≤5 % change) over the past 3-months.
6. Is in general good health, as determined by the investigator.
7. Willing to consume the investigational product daily for the duration of the trial.
8. Willing to wear a continuous glucose monitoring sensor for two 14-day periods.
9. Be willing to maintain stable dietary habits and physical activity levels throughout the trial period.
Exclusion Criteria
3\. Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
1. Complete abstinence from intercourse two weeks prior to administration of the investigational product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the investigational product in cases where participant discontinues the trial prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
3. Sexual partner(s) is/are exclusively female.
4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 1 week following the end of the trial.
5. Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the trial, and 2 weeks following the end of the trial.
4\. Are hypersensitive to any of the components of the investigational product or common food allergens.
5\. Has taken antibiotics within the previous 12-weeks prior to randomisation 6. Participant regularly takes probiotics, prebiotics, or fibre supplements (daily use in the 4 weeks prior to screening and up to baseline) 7. Has an intake of more than 19 g of fibre per day. 8. Has taken anti-obesity medication/supplement within the previous 12-weeks prior to randomisation.
9\. Participant is actively or has recently (3 months prior to randomisation) participated in a weight loss program or weight change of 5 % during the past 3 months.
10\. Participant has Type 1 or Type 2 Diabetes Mellitus. 11. Has a history of bariatric surgery. 12. Participant who is severely immuno-compromised (HIV positive, transplant patient, on antirejection medications, or has undergone chemotherapy or radiotherapy within the last year).
13\. Participant has significant comorbidities or an uncontrolled disease, as determined by the PI/Sub-Investigator on the basis of medical history and routine laboratory test results that may adversely affect the participant's ability to complete the trial or it's assessments or which may pose significant risk to the participant.
14\. Participant has a history of co-existing gastrointestinal, and/or gynaecological, and/or urologic pathology (e.g., colon cancer, colitis, Crohn's Disease, Celiac, Endometriosis, prostate cancer) or lactose intolerance.
15\. Has a gastrointestinal or chronic infective disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.), or with a history of such diseases.
16\. Has a history of drug and/or alcohol abuse at the time of enrolment.
<!-- -->
1. Consumes greater than nationally recommended units of alcohol per week (\>11 units for women \& \>17 units for men).
2. Is currently in treatment (or has been in the last 6 months) for alcohol/substance abuse
3. Has been diagnosed with alcohol/substance abuse disorder. 17. Has used oral/injectable steroids within the previous 30 days prior to Screening (or between Screening/Baseline Visit).
18\. Taking a medication that the investigator believes would interfere with the objectives of the trial or pose a safety risk or confound the interpretation of the trial results. Prohibited medications include:
<!-- -->
1. Metformin
2. Anti-psychotic drugs 19. If taking anti-hypertensive drugs, anti-depressive drugs, statins, or any other medication that the investigator determines could impact the results of the study, the participant must have been taking the product for at least 3 months prior to screening. (Changes to the dose during the trial will be assessed by the investigator for impact on trial results).
20\. Individual who work a shift work pattern that requires them to work \>1 nightshift per week.
21\. Individuals living in the same residence as a previously or currently enrolled participants on the trial.
22\. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
23\. Participant is currently, or planning, to participate in another interventional study during the study period.
24\. Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this trial.
25\. Individuals who have a history of non-compliance or, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Atlantia Food Clinical Trials
INDUSTRY
University College Cork
OTHER
Tate & Lyle
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Atlantia Food Clinical Trials
Cork, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Aisling Harrington
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AFCRO-129
Identifier Type: -
Identifier Source: org_study_id