Clinical trial NCT05593926: Fibre suppLements fOR Pre-diAbetes - An Assessment Oral Fibre Supplements on Pre-diabetes Outcome Measures
Official title: Fibre suppLements fOR Pre-diAbetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Lead sponsor: Myota GmbH
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2022-10-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, individually randomized, single-blind placebo-controlled trial
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c levels
timeFrame: 16 weeks
Secondary outcomes:
measure: HbA1c levels
timeFrame: 24 weeks
measure: Insulin
timeFrame: 16 and 24 weeks
measure: Insulin sensitivity
timeFrame: 16 weeks
measure: Lipid profile
timeFrame: 16 and 24 weeks
measure: Inflammatory markers
timeFrame: 16 and 24 weeks
measure: Blood pressure
timeFrame: 16 and 24 weeks
measure: Overall safety of the Myota Metabolic Regulator
timeFrame: Weeks 1-4
measure: To investigate intervention adherence
timeFrame: 24 weeks
measure: To investigate usability
timeFrame: 16 and 24 weeks
Other outcomes:
Locations:
city: Wellingborough
country: United Kingdom
facility: Albany House Medical Centre
state: Northamptonshire
city: London
country: United Kingdom
facility: Lindus Health
Study officials:
affiliation: Myota GmbH
name: Luke Twelves, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Myota GmbH
name: Thomas Gurry, PhD
role: STUDY_DIRECTOR
References: