Study to Investigate the Effect of Dietary Fibre Supplementation on Long-term Glucose Control in Prediabetic Subjects

NCT05157815 | Unknown

• 1 other identifier: AFCRO-129
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

glycemia; fiber; prediabetes

Outcome Measures

Primary Outcomes (1)

• Change in plasma HbA1c concentration

  Change from baseline to week 16 in the treatment group compared to placebo on plasma HbA1c (mmol/mol) concentration

  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)

  16 weeks

• Change in post-prandial Blood Glucose maximal concentration, derived from an Oral Glucose Tolerance Test (OGTT)

  16 weeks

• Change in post-prandial Blood Glucose time to peak, derived from an Oral Glucose Tolerance Test (OGTT)

  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)

  16 weeks

• Change in post-prandial insulin maximal concentration (Cmax) derived from an Oral Glucose Tolerance Test (OGTT)

  16 weeks

Other Outcomes (6)

• Change in gut hormones (GLP-1 and PYY) measured by iAUC (T-15 to T120 minutes)

  16 weeks

• Change in self-reported hunger and satiety measured by iAUC (T-15 to T120 minutes)

  16 weeks

• Change in the composite score of gastrointestinal symptoms, (bloating score + abdominal cramping score + stomach noises score + flatulence score)

  16 weeks

Study Arms (2)

Soluble Corn Fibre

EXPERIMENTAL

12g compound per Sachet (providing 10g fibre) consumed twice per day

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

Dietary Supplement: Calorie Matched Control

Interventions

Soluble Fibre DIETARY_SUPPLEMENT

10g soluble corn fibre to be consumed twice per day

Soluble Corn Fibre

Calorie Matched Control DIETARY_SUPPLEMENT

2g maltodextrin consumed twice per day

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \. Are aged less than 18 or greater than 70 years. 2. Participants who are pregnant, breastfeeding, or wish to become pregnant during the trial.
• \. 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.
• 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.
• \. Are hypersensitive to any of the components of the investigational product or common food allergens.
• \. 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.
• \. 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.
• \. 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).
• \. 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.
• \. 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.
• \. 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.
• \. Has a history of drug and/or alcohol abuse at the time of enrolment.

Sponsors & Collaborators

• Tate & Lyle: lead
• Atlantia Food Clinical Trials: collaborator
• University College Cork: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Feeding Behavior; Prediabetic State

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ieva Laurie, PhD

CONTACT

+447900632410; IEVA.LAURIE@TATEANDLYLE.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind: The relationship between the randomisation number and the group assignment will be unknown to the clinical research team, the sponsor, trial site staff, and the participants, i.e. the trial will be double-blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 15, 2021
• Study Start: October 4, 2021
• Primary Completion: March 30, 2023
• Study Completion: July 30, 2023
• Last Updated: December 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)