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Completed

NCT Number: NCT05593926

Fibre suppLements fOR Pre-diAbetes - An Assessment Oral Fibre Supplements on Pre-diabetes Outcome Measures

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albany House Medical Centre, Wellingborough, Northamptonshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. HbA1c levels

    Time frame: 16 weeks

    To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels

Secondary outcomes

  1. HbA1c levels

    Time frame: 24 weeks

    To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels

  2. Insulin

    Time frame: 16 and 24 weeks

    To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.

  3. Insulin sensitivity

    Time frame: 16 weeks

    To compare the effect of Myota's Metabolic Regulator versus placebo on insulin sensitivity as measured using ISI-OGTT.

  4. Lipid profile

    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.

  5. Inflammatory markers

    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).

  6. Blood pressure

    Time frame: 16 and 24 weeks

    To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure

  7. Overall safety of the Myota Metabolic Regulator

    Time frame: Weeks 1-4

    Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)

  8. To investigate intervention adherence

    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?

  9. To investigate usability

    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

Sponsors and collaborators

Lead sponsor

Myota GmbH

Industry

Collaborators

  • Lindus Health

Registry information

Official study title

Fibre suppLements fOR Pre-diAbetes

Acronym: FLORA

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 26, 2022
Registry last updated
Jan 17, 2024

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.

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