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| Name | Class |
|---|---|
| Lindus Health | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks. |
|
| Placebo | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myota Metabolic Regulator | Dietary Supplement | The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c levels | To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c levels | To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels | 24 weeks |
| Insulin | To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke Twelves, Dr | Myota GmbH | Principal Investigator |
| Thomas Gurry, PhD | Myota GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany House Medical Centre | Wellingborough | Northamptonshire | NN8 4RW | United Kingdom | ||
| Lindus Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38654680 | Derived | Hall CV, Twelves JL, Saxena M, Scapozza L, Gurry T. Effects of a diverse prebiotic fibre supplement on HbA1c, insulin sensitivity and inflammatory biomarkers in pre-diabetes: a pilot placebo-controlled randomised clinical trial. Br J Nutr. 2024 Jul 14;132(1):68-76. doi: 10.1017/S0007114524000904. Epub 2024 Apr 24. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2023 | Jul 28, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Two-arm, individually randomized, single-blind placebo-controlled trial
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Participants will be randomised to Placebo or the Myota Metabolic Regulator, with a 1:1 randomisation ratio stratified by gender and BMI.
| 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. | 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. | 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). | 16 and 24 weeks |
| Blood pressure | To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure | 16 and 24 weeks |
| Overall safety of the Myota Metabolic Regulator | Number of participants reporting adverse events (AEs) and serious adverse events (SAEs) | 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? | 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 | 16 and 24 weeks |
| London |
| SE1 4GT |
| United Kingdom |