An interventional study of Myota Metabolic Regulator in Pre-diabetes, sponsored by Myota GmbH. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by Myota GmbH · Not applicable, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Myota GmbH is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks.
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
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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