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

Not Applicable

Completed

• Conditions: Pre-diabetes
• Interventions: Dietary Supplement: Myota Metabolic Regulator

• Registration Number: NCT05593926
• Lead Sponsor: Myota GmbH

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-26
• Study Start: 2022-11-16
• Primary Completion: 2023-08-26
• Status Verified: 2024-01
• Study Completion: 2024-01-15
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Myota Metabolic Regulator	The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks.

Primary Outcome Measures

Name	Time	Method
HbA1c levels	16 weeks	To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels

Secondary Outcome Measures

Name	Time	Method
Insulin	16 and 24 weeks	To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.
Inflammatory markers	16 and 24 weeks	To compare the effect of Myota's Metabolic Regulator versus placebo on inflammatory markers (IL-6, IL-8, IL-10, CRP, TNF-a).
Blood pressure	16 and 24 weeks	To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure
Lipid profile	16 and 24 weeks	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.
HbA1c levels	24 weeks	To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Overall safety of the Myota Metabolic Regulator	Weeks 1-4	Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
Insulin sensitivity	16 weeks	To compare the effect of Myota's Metabolic Regulator versus placebo on insulin sensitivity as measured using ISI-OGTT.
To investigate intervention adherence	24 weeks	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?
To investigate usability	16 and 24 weeks	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

Trial Locations

Locations (2)

Lindus Health; 🇬🇧 London, United Kingdom

Albany House Medical Centre; 🇬🇧 Wellingborough, Northamptonshire, United Kingdom