Fibre suppLements fOR Pre-diAbetes - An Assessment Oral Fibre Supplements on Pre-diabetes Outcome Measures

Study Overview
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Brief Summary
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This trial will investigate whether a powdered fibre mix helps maintain healthy blood glucose levels in participants with pre-diabetes, where high blood sugar is a risk of diabetes.

Detailed Description
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Pre-diabetes is characterised by high blood glucose levels, high plasma cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL). Dietary fibre consumption has been hypothesised to improve these metabolic parameters through the viscous properties, and the production of short-chain fatty acids (SCFA) in the intestine.

Official Title
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Fibre suppLements fOR Pre-diAbetes

Conditions
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Pre-diabetes

Intervention / Treatment
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* Dietary Supplement: Myota Metabolic Regulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide informed consent Have a Body Mass Index (BMI) of at least 25 kg/m2 Men or post menopausal* women aged 18-70 Identified as pre-diabetic (HbA1c 6.0% (42 mmol/mol) to 6.4% (47 mmol/ mol)) within the previous 12 months Baseline HbA1c result within the range 5.8% (40 mmol/mol) - 6.5% (48 mmol/mol) Willing to complete in clinic blood tests and a participant trial survey Have access to a smartphone or a computer Exclusion Criteria: Receiving medication to treat Type 1 or Type 2 diabetes in the previous 6 months Have a Body Mass Index (BMI) <25 kg/m2 and >45 kg/m2 Loss of more than 5% body weight in last 3 months Current participation in weight loss program or planned in the next 16 weeks Steroid use (except for over the counter NSAID's, topical steroids and inhalers) Severe hepatic diseases (including chronic persistent hepatitis, liver cirrhosis or the co-occurrence of positive hepatitis B virus surface antigen and abnormal hepatic transaminase (serum concentrations of alanine transaminase or aspartate transaminase >2.5× the upper normal limit)) Continuous antibiotic use for >3 days within 4 weeks prior to enrolment Continuous use of weight-loss drug for within 3 months of study entry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm, individually randomized, single-blind placebo-controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks. | Dietary Supplement: Myota Metabolic Regulator<br>* The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks.<br>|
| No Intervention: Placebo<br>Placebo will be 2g of powdered cellulose, to be taken daily alongside usual diet for 24 weeks. Placebo will be 2g of powdered cellulose, to be taken daily alongside usual diet for 24 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels | To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels | To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels | 24 weeks | 
| Insulin | To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration. | 16 and 24 weeks | 
| Insulin sensitivity | To compare the effect of Myota's Metabolic Regulator versus placebo on insulin sensitivity as measured using ISI-OGTT. | 16 weeks | 
| Lipid profile | To compare the effect of Myota's Metabolic Regulator versus placebo on cholesterol [total, low-density lipoprotein (LDL), high-density lipoprotein (HDL)] and triglycerides levels. | 16 and 24 weeks | 
| Inflammatory markers | To compare the effect of Myota's Metabolic Regulator versus placebo on inflammatory markers (IL-6, IL-8, IL-10, CRP, TNF-a). | 16 and 24 weeks | 
| Blood pressure | To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure | 16 and 24 weeks | 
| Overall safety of the Myota Metabolic Regulator | Number of participants reporting adverse events (AEs) and serious adverse events (SAEs) | Weeks 1-4 | 
| To investigate intervention adherence | A daily intervention adherence questionnaire will be used to assess the extent to which participant's adhered to the intervention. This will consist of two questions: Did you consume the full sachet of study product yesterday? Yes/No [If no] Why were you unable to take the product yesterday? | 24 weeks | 
| To investigate usability | A usability questionnaire will be administered to assess how easily participant's were able to use the intervention or placebo. This will consist of two statements: I found the supplement easy to take. Strongly disagree to Strongly agree (5 options) I would like to take this supplement in my normal daily life. Yes/no | 16 and 24 weeks |