Myota Metabolic Regulator
Dietary SupplementThe functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks.
NCT Number: NCT05593926
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Albany House Medical Centre, Wellingborough, Northamptonshire, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: 16 weeks
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Time frame: 24 weeks
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Time frame: 16 and 24 weeks
To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.
Time frame: 16 weeks
To compare the effect of Myota's Metabolic Regulator versus placebo on insulin sensitivity as measured using ISI-OGTT.
Time frame: 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.
Time frame: 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).
Time frame: 16 and 24 weeks
To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure
Time frame: Weeks 1-4
Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
Time frame: 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?
Time frame: 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
Myota GmbH
Industry
Fibre suppLements fOR Pre-diAbetes
Acronym: FLORA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04057339
Behavior, Fasting
La Jolla, California, United States
View Trial DetailsNCT03077360
Body Weight, Diabetes Mellitus
Aurora, Colorado, United States
View Trial DetailsNCT04621929
Body Weight, Glucose Intolerance
Gainesville, Florida, United States
View Trial DetailsNCT05038137
Behavior, Breast Cancer
Charleston, South Carolina, United States
View Trial Details