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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
61
The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks.
Albany House Medical Centre
Wellingborough, Northamptonshire, United Kingdom
Lindus Health
London, United Kingdom
HbA1c levels
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Time frame: 16 weeks
HbA1c levels
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Time frame: 24 weeks
Insulin
To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 16 and 24 weeks
Blood pressure
To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure
Time frame: 16 and 24 weeks
Overall safety of the Myota Metabolic Regulator
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Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
Time frame: 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?
Time frame: 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
Time frame: 16 and 24 weeks