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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-16

Study Completion Date

2024-01-15

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.

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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.

Conditions

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Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm, individually randomized, single-blind placebo-controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Participants will be randomised to Placebo or the Myota Metabolic Regulator, with a 1:1 randomisation ratio stratified by gender and BMI.

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Myota Metabolic Regulator

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No