NCT05593926

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

November 16, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

October 20, 2022

Last Update Submit

January 16, 2024

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c levels

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

    16 weeks

Secondary Outcomes (9)

  • HbA1c levels

    24 weeks

  • Insulin

    16 and 24 weeks

  • Insulin sensitivity

    16 weeks

  • Lipid profile

    16 and 24 weeks

  • Inflammatory markers

    16 and 24 weeks

  • +4 more secondary outcomes

Study Arms (2)

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.

Dietary Supplement: Myota Metabolic Regulator

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.

Interventions

Myota Metabolic RegulatorDIETARY_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.

Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \>2.5Ă— 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Albany House Medical Centre

Wellingborough, Northamptonshire, NN8 4RW, United Kingdom

Location

Lindus Health

London, SE1 4GT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38654680DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Luke Twelves, Dr

    Myota GmbH

    PRINCIPAL INVESTIGATOR

  • Thomas Gurry, PhD

    Myota GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomised to Placebo or the Myota Metabolic Regulator, with a 1:1 randomisation ratio stratified by gender and BMI.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-arm, individually randomized, single-blind placebo-controlled trial
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director (CRO)

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 26, 2022

Study Start

November 16, 2022

Primary Completion

August 26, 2023

Study Completion

January 15, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)