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

Fibre suppLements fOR Pre-diAbetes

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.

Study Overview

• Status: Completed
• Conditions: Pre-diabetes
• Intervention / Treatment: Dietary supplement: Myota Metabolic Regulator

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 4GT
    • Lindus Health
  • Northamptonshire
    • Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
      • Albany House Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Myota GmbH
• Collaborators: Lindus Health
• Investigators: Principal Investigator: Luke Twelves, Dr, Myota GmbH; Study Director: Thomas Gurry, PhD, Myota GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): August 26, 2023
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: LH005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No