Dietary HabitsNCT05157815
Study to Investigate the Effect of Dietary Fibre Supplementation on Long-term Glucose Control in Prediabetic Subjects
A study testing Soluble Fibre in people with Dietary Habits, run by Tate & Lyle at 1 site in Ireland.
Trial summary
The purpose of the study is to explore the potential metabolic health benefits of a dietary fibre intervention by using Soluble Fibre in a human intervention study in Healthy Obese Pre-diabetic participants over a period of 16 weeks with a focus on long term glucose control. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Soluble Fibre
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteIreland
- Study dates
- 4 Oct 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to give written informed consent.
- Males \& females aged 18 to 70 years (inclusive).
- Has a BMI between ≥30 and ≤40 kg/m2.
- HbA1c between ≥38.8 and ≤47 mmol/mol (5.7-6.4 %)
- Has a stable body weight (≤5 % change) over the past 3-months.
- Is in general good health, as determined by the investigator.
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- Willing to consume the investigational product daily for the duration of the trial.
- Willing to wear a continuous glucose monitoring sensor for two 14-day periods.
- Be willing to maintain stable dietary habits and physical activity levels throughout the trial period.
Who cannot join
- 1. Are aged less than 18 or greater than 70 years. 2. Participants who are pregnant, breastfeeding, or wish to become pregnant during the trial.
- 3. Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
- 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).
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
- Sexual partner(s) is/are exclusively female.
- 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.
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- 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.
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- Consumes greater than nationally recommended units of alcohol per week (>11 units for women \& >17 units for men).
- Is currently in treatment (or has been in the last 6 months) for alcohol/substance abuse
- 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:
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- Metformin
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Atlantia Food Clinical Trials
Cork
Aisling Harrington, +353 21 430 7442, aharrington@atlantiatrials.com
Noel Caplice, PhD
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Effect of 16 Weeks of Twice Daily Supplementation With Soluble Corn Fibre on Long Term Glucose Control in Prediabetic Subjects
The purpose of the study is to explore the potential metabolic health benefits of a dietary fibre intervention by using Soluble Fibre in a human intervention study in Healthy Obese Pre-diabetic participants over a period of 16 weeks with a focus on long term glucose control.
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.
- Conditions
- Dietary Habits
- Being tested
- Soluble Fibre, Calorie Matched Control
- Keywords
- glycemia, fiber, prediabetes
- Medical subject headings
- Feeding Behavior, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble FibreDietary supplement
10g soluble corn fibre to be consumed twice per day
Calorie Matched ControlDietary supplement
2g maltodextrin consumed twice per day
| Study group | Role | What they receive |
|---|---|---|
| Soluble Corn Fibre | Experimental | 12g compound per Sachet (providing 10g fibre) consumed twice per day Receives: Dietary Supplement: Soluble Fibre |
| Maltodextrin | Placebo comparator | Calorie matched control of 2 g compound per sachet (0 g fibre), composed of: Maltodextrin, consumed twice per day Receives: Dietary Supplement: Calorie Matched Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma HbA1c concentration
Change from baseline to week 16 in the treatment group compared to placebo on plasma HbA1c (mmol/mol) concentration
Measured: 16 weeks
Secondary outcomes (13)
Change in post-prandial Blood Glucose (mmol/L) measured by incremental Area Under the Curve (iAUC) derived from an Oral Glucose Tolerance Test (OGTT)
Measured: 16 weeks
Change in post-prandial Blood Glucose maximal concentration, derived from an Oral Glucose Tolerance Test (OGTT)
Measured: 16 weeks
Change in post-prandial Blood Glucose time to peak, derived from an Oral Glucose Tolerance Test (OGTT)
Measured: 16 weeks
Change in post-prandial insulin (mIU/L) as measured by incremental Area Under the Curve (iAUC) derived from an Oral Glucose Tolerance Test (OGTT)
Measured: 16 weeks
Change in post-prandial insulin maximal concentration (Cmax) derived from an Oral Glucose Tolerance Test (OGTT)
Measured: 16 weeks
Change in post-prandial Blood Insulin time to peak (Tmax), derived from an Oral Glucose Tolerance Test (OGTT)
Measured: 16 weeks
Change in insulin resistance (mIU/L)
Measured: 16 weeks
Change in lipids (mmol/L): Triglycerides (TG), Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL), Low-Density Lipoprotein Cholesterol (LDL)
Measured: 16 weeks
Change in waist-to-hip ratio
Measured: 16 weeks
Change in BMI (kg/m2)
Measured: 16 weeks
Continuous blood glucose monitoring (during run-in & 2-weeks before End of Study) as measured by Freestyle Libre Glucose Monitoring System, a continuous glucose monitoring (CGM) device.
Measured: 16 weeks
Change in Fasting Blood Glucose (FBG) (mmol/L)
Measured: 16 weeks
Change in Fasting Insulin (mIU/L).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start4 Oct 2021
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tate & Lyle
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, University College Cork
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157815
- Sponsor's protocol ID
- AFCRO-129
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Effect of 16 Weeks of Twice Daily Supplementation With Soluble Corn Fibre on Long Term Glucose Control in Prediabetic Subjects
- ClinicalTrials.gov ID
- NCT05157815
- Acronym / sponsor ID
- AFCRO-129
- Conditions
- Dietary Habits
- Keywords
- glycemia, fiber, prediabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tate & LyleIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, University College Cork
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to explore the potential metabolic health benefits of a dietary fibre intervention by using Soluble Fibre in a human intervention study in Healthy Obese Pre-diabetic participants over a period of 16 weeks with a focus on long term glucose control.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soluble Corn Fibre | Experimental | Dietary Supplement: Soluble Fibre12g compound per Sachet (providing 10g fibre) consumed twice per day |
| Maltodextrin | Placebo comparator | Dietary Supplement: Calorie Matched ControlCalorie matched control of 2 g compound per sachet (0 g fibre), composed of: Maltodextrin, consumed twice per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able to give written informed consent.
- Males \& females aged 18 to 70 years (inclusive).
- Has a BMI between ≥30 and ≤40 kg/m2.
- HbA1c between ≥38.8 and ≤47 mmol/mol (5.7-6.4 %)
- Has a stable body weight (≤5 % change) over the past 3-months.
Key exclusion criteria (29 listed)
- 1. Are aged less than 18 or greater than 70 years. 2. Participants who are pregnant, breastfeeding, or wish to become pregnant during the trial.
- 3. Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble Fibre10g soluble corn fibre to be consumed twice per day | Dietary supplement | Soluble Corn Fibre |
| Calorie Matched Control2g maltodextrin consumed twice per day | Dietary supplement | Maltodextrin |
Primary outcome
Change in plasma HbA1c concentration
Time frame: 16 weeks
Change from baseline to week 16 in the treatment group compared to placebo on plasma HbA1c (mmol/mol) concentration
13 secondary outcomes
Change in post-prandial Blood Glucose (mmol/L) measured by incremental Area Under the Curve (iAUC) derived from an Oral Glucose Tolerance Test (OGTT)
Time frame: 16 weeks
Change in post-prandial Blood Glucose maximal concentration, derived from an Oral Glucose Tolerance Test (OGTT)
Time frame: 16 weeks
Change in post-prandial Blood Glucose time to peak, derived from an Oral Glucose Tolerance Test (OGTT)
Time frame: 16 weeks
Change in post-prandial insulin (mIU/L) as measured by incremental Area Under the Curve (iAUC) derived from an Oral Glucose Tolerance Test (OGTT)
Time frame: 16 weeks
Change in post-prandial insulin maximal concentration (Cmax) derived from an Oral Glucose Tolerance Test (OGTT)
Time frame: 16 weeks
Change in post-prandial Blood Insulin time to peak (Tmax), derived from an Oral Glucose Tolerance Test (OGTT)
Time frame: 16 weeks
Change in insulin resistance (mIU/L)
Time frame: 16 weeks
Change in lipids (mmol/L): Triglycerides (TG), Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL), Low-Density Lipoprotein Cholesterol (LDL)
Time frame: 16 weeks
Change in waist-to-hip ratio
Time frame: 16 weeks
Change in BMI (kg/m2)
Time frame: 16 weeks
Continuous blood glucose monitoring (during run-in & 2-weeks before End of Study) as measured by Freestyle Libre Glucose Monitoring System, a continuous glucose monitoring (CGM) device.
Time frame: 16 weeks
Change in Fasting Blood Glucose (FBG) (mmol/L)
Time frame: 16 weeks
Change in Fasting Insulin (mIU/L).
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soluble Fibre in people with Dietary Habits, run by Tate & Lyle at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ieva Laurie, PhD (+447900632410, IEVA.LAURIE@TATEANDLYLE.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma HbA1c concentration (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.