Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05593926
Other study ID # LH005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04082585 - Total Health Improvement Program Research Project
Enrolling by invitation NCT05367024 - Broccoli Effect on Glycated Haemoglobin (HbA1c) N/A
Withdrawn NCT02400450 - Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes N/A
Completed NCT02933424 - Project Plant Protein: the P3 Study in Humans N/A
Completed NCT02656212 - Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2) Phase 1
Completed NCT02330276 - Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin Phase 1
Completed NCT01488279 - Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy N/A
Completed NCT00831129 - A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs Phase 2/Phase 3
Completed NCT00536250 - Study to Investigate the Pathophysiology of Type 2 Diabetes in Youth N/A
Recruiting NCT05563090 - Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
Active, not recruiting NCT04991142 - Models of Nutrition From Continuous Glucose Monitors
Completed NCT02759055 - Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard) N/A
Completed NCT00775684 - Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass N/A
Completed NCT03695913 - Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes N/A
Completed NCT04051008 - CTSI Pilot: Improving Adherence to Diabetic Diet N/A
Recruiting NCT04897945 - A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus N/A
Not yet recruiting NCT04442451 - Mechanisms of Fatigability With Diabetes N/A
Not yet recruiting NCT05925933 - High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes N/A
Active, not recruiting NCT05654051 - The SLIM LIVER Study Phase 2
Completed NCT02919397 - Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes N/A