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

Sponsor

Myota GmbH (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05593926

Collaborator

Lindus Health (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-diabetes	Dietary Supplement: Myota Metabolic Regulator	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

Fibre suppLements fOR Pre-diAbetes

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: 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.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: 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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c levels [24 weeks]
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Insulin [16 and 24 weeks]
To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.
Insulin sensitivity [16 weeks]
To compare the effect of Myota's Metabolic Regulator versus placebo on insulin sensitivity as measured using ISI-OGTT.
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.
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
Overall safety of the Myota Metabolic Regulator [Weeks 1-4]
Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Myota GmbH
Lindus Health

Investigators

Principal Investigator: Luke Twelves, Dr, Myota GmbH
Study Director: Thomas Gurry, PhD, Myota GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr John Luke Twelves, Medical Director (CRO), Myota GmbH

ClinicalTrials.gov Identifier:

NCT05593926

Other Study ID Numbers:

LH005

First Posted:

Oct 26, 2022

Last Update Posted:

Nov 3, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Prediabetic State

Glucose Intolerance

Study Results

No Results Posted as of Nov 3, 2022