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

Primary Purpose

Pre-diabetes

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Myota Metabolic Regulator
Sponsored by
Myota GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Albany House Medical Centre
  • Lindus Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Placebo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c levels
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Insulin
To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.
Insulin sensitivity
To compare the effect of Myota's Metabolic Regulator versus placebo on insulin sensitivity as measured using ISI-OGTT.
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.
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).
Blood pressure
To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure
Overall safety of the Myota Metabolic Regulator
Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
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?
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

Full Information

First Posted
October 20, 2022
Last Updated
September 5, 2023
Sponsor
Myota GmbH
Collaborators
Lindus Health
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1. Study Identification

Unique Protocol Identification Number
NCT05593926
Brief Title
Fibre suppLements fOR Pre-diAbetes - An Assessment Oral Fibre Supplements on Pre-diabetes Outcome Measures
Acronym
FLORA
Official Title
Fibre suppLements fOR Pre-diAbetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
August 26, 2023 (Actual)
Study Completion Date
October 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Myota GmbH
Collaborators
Lindus Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm, individually randomized, single-blind placebo-controlled trial
Masking
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.
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks.
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Myota Metabolic Regulator
Intervention Description
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 Measure Information:
Title
HbA1c levels
Description
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
HbA1c levels
Description
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Time Frame
24 weeks
Title
Insulin
Description
To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.
Time Frame
16 and 24 weeks
Title
Insulin sensitivity
Description
To compare the effect of Myota's Metabolic Regulator versus placebo on insulin sensitivity as measured using ISI-OGTT.
Time Frame
16 weeks
Title
Lipid profile
Description
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.
Time Frame
16 and 24 weeks
Title
Inflammatory markers
Description
To compare the effect of Myota's Metabolic Regulator versus placebo on inflammatory markers (IL-6, IL-8, IL-10, CRP, TNF-a).
Time Frame
16 and 24 weeks
Title
Blood pressure
Description
To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure
Time Frame
16 and 24 weeks
Title
Overall safety of the Myota Metabolic Regulator
Description
Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Weeks 1-4
Title
To investigate intervention adherence
Description
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?
Time Frame
24 weeks
Title
To investigate usability
Description
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
Time Frame
16 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke Twelves, Dr
Organizational Affiliation
Myota GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Gurry, PhD
Organizational Affiliation
Myota GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Albany House Medical Centre
City
Wellingborough
State/Province
Northamptonshire
ZIP/Postal Code
NN8 4RW
Country
United Kingdom
Facility Name
Lindus Health
City
London
ZIP/Postal Code
SE1 4GT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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