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

Pre-diabetes Clinical Trial

— FLORA  

Official title:

Fibre suppLements fOR Pre-diAbetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05593926
• Other study ID #: LH005
• Status: Completed
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: January 2024
• Source: Myota GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 15, 2024
• Est. primary completion date: August 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Lindus Health	London
United Kingdom	Albany House Medical Centre	Wellingborough	Northamptonshire

Sponsors (2)

Lead Sponsor	Collaborator
Myota GmbH	Lindus Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c levels	To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels	16 weeks
Secondary	HbA1c levels	To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels	24 weeks
Secondary	Insulin	To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.	16 and 24 weeks
Secondary	Insulin sensitivity	To compare the effect of Myota's Metabolic Regulator versus placebo on insulin sensitivity as measured using ISI-OGTT.	16 weeks
Secondary	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
Secondary	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
Secondary	Blood pressure	To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure	16 and 24 weeks
Secondary	Overall safety of the Myota Metabolic Regulator	Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)	Weeks 1-4
Secondary	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
Secondary	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