Pre-diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMyota 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.
Sponsors
Lindus Health
Myota GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will be randomised to Placebo or the Myota Metabolic Regulator, with a 1:1 randomisation ratio stratified by gender and BMI.
Intervention model description
Two-arm, individually randomized, single-blind placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c levels | 16 weeks | To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| HbA1c levels | 24 weeks | To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels |
| 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 |
| Blood pressure | 16 and 24 weeks | To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure |
Countries
United Kingdom
Outcome results
None listed