A Probiotic Strain for Metabolic Health and Well Being: Join Our trial

If you have a recent HbA1c test result of between 42.1 mmol/mol and 51.9 mmol/mol (6.0% to 6.9%) we invite you to  take part in this important trial. HbA1c values indicate your average blood glucose (sugar) level over the past 2–3 months, providing a snapshot of long-term blood glucose control. 

Metabolic syndrome is the name for a group of health  problems that may put you at risk of type 2 diabetes or  conditions that affect your heart or blood vessels. People are seeking new tools to support their metabolic health journey,  specifically solutions that support their blood glucose  regulation. Probiotics are live bacteria and yeasts promoted as having various health benefits 

The aim of the trial is to find out the potential impact of a probiotic strain (Levilactobacillus brevis) on blood glucose (sugar) levels and supporting well-being and metabolic health (how the body processes sugar and fats) when taken as a daily dietary supplement. 

During the trial, you will be randomly assigned using a  computer program (e.g. like rolling a dice) to one of three  groups: high dose probiotic, low dose probiotic or placebo. 

The trial is double-blind, meaning that you and the trial team  will not know what group you are assigned to until the end of the trial. 

You will complete at-home assessments, including wearing a continuous glucose monitoring (CGM) device along with blood and stool sample collection, plus with online surveys. Blood  tests will be conducted at a clinic at three key points: at the start of the trial (baseline), after 6 weeks, and after 8 weeks. 

The trial participation will take a total of 10 weeks. 

Please contact us at gsquared@lindushealth.com if you have any questions.

Participant information Sheet

Informed Consent Form

Sponsored by

Patrocinado por

Gesponsert von

Gesponsert von

Opdrachtgever:

Participants

Participantes

Teilnehmenden

Deelnemers:

60

People

Personen

Participate by

Participar mediante

Abschlussdatum

Uiterlijke Inschrijving:

July 7, 2025

7.7.2025

7.7.2025

7.7.2025

Who is the study for? 

Individuals who: 

  • Are male aged 25-50 years old, or pre-menopausal  female aged 25-45 years old 
  • Have evidence of a recent HbA1c result of a recent  HbA1c result between 42.1 mmol/mol and 51.9mmol/mol (6.0% to 6.9%) 
  • Current BMI between 20-45 kg/m2 
  • Are willing to wear a continuous glucose monitor for up to 6 weeks 
  • Are willing to collect (at-home) stool samples, (at-clinic in Marylebone, London) blood tests and online surveys

What is expected of me? 

Here’s a step-by-step guide on what to expect:

1. Pre-Screening Survey Online
  • Start by completing a brief survey on this website to check if the trial is suitable for you
2. Upload Medical Information
  • You'll be asked to upload evidence of a recent HbA1c result to assess your eligibility. To do so you will need to provide initial consent.
3. Video Informed Consent and Screening Call with the Trial Investigator
  • After successfully completing the pre-screening, you'll have a video call with a member of the trial team where you will be fully informed about all aspects of the trial and asked some questions about your current health status. If you are interested in and eligible for participation, you will be asked to electronically sign a consent form.
4. Clinic Visit and Baseline Assessments
  • You'll have a blood test at a local clinic (Marylebone, London), and we'll ship trial equipment to you to support you with the trial.
  • Once you have the trial equipment, we will ask you to do baseline assessments including a blood test, stool sample collection, continuously wear a continuous glucose monitor (CGM) for 2 weeks, including video calls to help you activate the CGM and return the trial equipment, and complete questionnaires.
  • Costs for these visits will be covered by the trial participation payment (see 'What is the benefit for me').
5. Randomisation
  • A trial investigator will confirm your final eligibility and you will be randomly assigned to one of the three groups (1:1:1 allocation, meaning that you have an equal chance of being assigned to either group) after which you will be shipped the probiotic/placebo to your home address and be asked to take 1 capsule by mouth each morning per day for 6 weeks.
  • You will also be asked to continue to wear the CGM for a further 4 weeks.
6. Follow-Up
  • You will carry out trial activities and have follow-up assessments scheduled at specific time points (Week 6 and 8) until the trial completion at the end of Week 8.
  • Most activities can be completed at home, aside from blood tests which will be done at a central clinics in Marylebone, London.

What is the benefit for me?

If you take part in the trial, you will receive up to £200 for your time taken to collect samples and complete surveys for the trial. This will also cover expenses for your travel to the central clinic for your blood tests.

As with all participation in clinical research, the information that you contribute could help improve the lives of people in the future. This means you could have a positive impact on the lives of people living with elevated HbA1c levels.

A Probiotic Strain for Metabolic Health and Well Being: Join Our trial

If you have a recent HbA1c test result of between 42.1 mmol/mol and 51.9 mmol/mol (6.0% to 6.9%) we invite you to  take part in this important trial. HbA1c values indicate your average blood glucose (sugar) level over the past 2–3 months, providing a snapshot of long-term blood glucose control. 

Metabolic syndrome is the name for a group of health  problems that may put you at risk of type 2 diabetes or  conditions that affect your heart or blood vessels. People are seeking new tools to support their metabolic health journey,  specifically solutions that support their blood glucose  regulation. Probiotics are live bacteria and yeasts promoted as having various health benefits 

The aim of the trial is to find out the potential impact of a probiotic strain (Levilactobacillus brevis) on blood glucose (sugar) levels and supporting well-being and metabolic health (how the body processes sugar and fats) when taken as a daily dietary supplement. 

During the trial, you will be randomly assigned using a  computer program (e.g. like rolling a dice) to one of three  groups: high dose probiotic, low dose probiotic or placebo. 

The trial is double-blind, meaning that you and the trial team  will not know what group you are assigned to until the end of the trial. 

You will complete at-home assessments, including wearing a continuous glucose monitoring (CGM) device along with blood and stool sample collection, plus with online surveys. Blood  tests will be conducted at a clinic at three key points: at the start of the trial (baseline), after 6 weeks, and after 8 weeks. 

The trial participation will take a total of 10 weeks. 

Please contact us at gsquared@lindushealth.com if you have any questions.

Participant information Sheet

Informed Consent Form

Click here to take part
Haga clic aquí para participar
Teilnehmen
Klik hier om deel te nemen

Study for

Estudio dirigido a

Zielgrupper der Studie

Onderzoek voor:

Individuals with evidence of a recent HbA1c result between 42.1 mmol/mol and 51.9mmol/mol (6.0% to 6.9%)

Sponsored by

Patrocinado por

Gesponsert von

Opdrachtgever:

Participants

Participantes

Teilnehmenden

Deelnemers:

60

People

Personen

Participate by

Participar mediante

Abschlussdatum

Duur van onderzoek:

July 7, 2025

7.7.2025

7.7.2025

7.7.2025

Who is the study for? 

¿A quién va dirigido el estudio?

Für wen ist die Studie geeignet?

Voor wie is het onderzoek bedoeld?

Individuals who: 

  • Are male aged 25-50 years old, or pre-menopausal  female aged 25-45 years old 
  • Have evidence of a recent HbA1c result of a recent  HbA1c result between 42.1 mmol/mol and 51.9mmol/mol (6.0% to 6.9%) 
  • Current BMI between 20-45 kg/m2 
  • Are willing to wear a continuous glucose monitor for up to 6 weeks 
  • Are willing to collect (at-home) stool samples, (at-clinic in Marylebone, London) blood tests and online surveys

What is expected of me? 

¿Qué se espera de mí?

Was wird von mir erwartet?

Wat wordt van mij verwacht?

Here’s a step-by-step guide on what to expect:

1. Pre-Screening Survey Online
  • Start by completing a brief survey on this website to check if the trial is suitable for you
2. Upload Medical Information
  • You'll be asked to upload evidence of a recent HbA1c result to assess your eligibility. To do so you will need to provide initial consent.
3. Video Informed Consent and Screening Call with the Trial Investigator
  • After successfully completing the pre-screening, you'll have a video call with a member of the trial team where you will be fully informed about all aspects of the trial and asked some questions about your current health status. If you are interested in and eligible for participation, you will be asked to electronically sign a consent form.
4. Clinic Visit and Baseline Assessments
  • You'll have a blood test at a local clinic (Marylebone, London), and we'll ship trial equipment to you to support you with the trial.
  • Once you have the trial equipment, we will ask you to do baseline assessments including a blood test, stool sample collection, continuously wear a continuous glucose monitor (CGM) for 2 weeks, including video calls to help you activate the CGM and return the trial equipment, and complete questionnaires.
  • Costs for these visits will be covered by the trial participation payment (see 'What is the benefit for me').
5. Randomisation
  • A trial investigator will confirm your final eligibility and you will be randomly assigned to one of the three groups (1:1:1 allocation, meaning that you have an equal chance of being assigned to either group) after which you will be shipped the probiotic/placebo to your home address and be asked to take 1 capsule by mouth each morning per day for 6 weeks.
  • You will also be asked to continue to wear the CGM for a further 4 weeks.
6. Follow-Up
  • You will carry out trial activities and have follow-up assessments scheduled at specific time points (Week 6 and 8) until the trial completion at the end of Week 8.
  • Most activities can be completed at home, aside from blood tests which will be done at a central clinics in Marylebone, London.

Contact our study team

What is the benefit for me?

¿En qué me beneficia?

Welchen Nutzen habe ich davon?

Wat is het voordeel voor mij?

If you take part in the trial, you will receive up to £200 for your time taken to collect samples and complete surveys for the trial. This will also cover expenses for your travel to the central clinic for your blood tests.

As with all participation in clinical research, the information that you contribute could help improve the lives of people in the future. This means you could have a positive impact on the lives of people living with elevated HbA1c levels.

Complete this questionnaire to take part.

Fülle diesen Fragebogen aus, um herauszufinden, ob Du berechtigt bist