Pre-diabetesFLORANCT05593926
Fibre suppLements fOR Pre-diAbetes - An Assessment Oral Fibre Supplements on Pre-diabetes Outcome Measures
A study testing Myota Metabolic Regulator in people with Pre-diabetes, run by Myota GmbH at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Myota Metabolic Regulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Nov 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Lindus Health
London, SE1 4GT
Albany House Medical Centre
Wellingborough, Northamptonshire, NN8 4RW
About this study
Official title: Fibre suppLements fOR Pre-diAbetes
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.
Read the 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.
- Conditions
- Pre-diabetes
- Being tested
- Myota Metabolic Regulator
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Measured: 16 weeks
Secondary outcomes (9)
HbA1c levels
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
Measured: 24 weeks
Insulin
To compare the effect of Myota's Metabolic Regulator versus placebo on blood insulin concentration.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 16 and 24 weeks
Blood pressure
To compare the effect of Myota's Metabolic Regulator versus placebo on diastolic and systolic blood pressure
Measured: 16 and 24 weeks
Overall safety of the Myota Metabolic Regulator
Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
Measured: 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?
Measured: 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
Measured: 16 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start16 Nov 2022
- Primary completion26 Aug 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, individually randomized, single-blind placebo-controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myota GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Principal investigator, Dr John Luke Twelves, Myota GmbH
- Investigators
- Luke Twelves, Dr, Principal investigator, Myota GmbHThomas Gurry, PhD, Study director, Myota GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593926
- Sponsor's protocol ID
- LH005
- Acronym
- FLORA
- Status last verified
- Jan 2024
- First submitted
- 20 Oct 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38654680
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibre suppLements fOR Pre-diAbetes
- ClinicalTrials.gov ID
- NCT05593926
- Acronym / sponsor ID
- FLORA / LH005
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Myota GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 26 Aug 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-arm, individually randomized, single-blind placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Myota Metabolic RegulatorThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myota Metabolic RegulatorThe 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 | Intervention |
Primary outcome
HbA1c levels
Time frame: 16 weeks
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
9 secondary outcomes
HbA1c levels
Time frame: 24 weeks
Insulin
Time frame: 16 and 24 weeks
Insulin sensitivity
Time frame: 16 weeks
Lipid profile
Time frame: 16 and 24 weeks
Inflammatory markers
Time frame: 16 and 24 weeks
Blood pressure
Time frame: 16 and 24 weeks
Overall safety of the Myota Metabolic Regulator
Time frame: Weeks 1-4
To investigate intervention adherence
Time frame: 24 weeks
To investigate usability
Time frame: 16 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 38654680Hall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Twelves, Dr principal investigator
Myota GmbH
Thomas Gurry, PhD study director
Myota GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myota Metabolic Regulator in people with Pre-diabetes, run by Myota GmbH at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c levels (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.