G Squared
Research type
Research Study
Full title
A Probiotic Strain for Metabolic Health and Well Being: A randomised placebo- controlled trial
IRAS ID
354296
Contact name
Rianna Mortimer
Contact email
Sponsor organisation
Danisco Sweeteners Oy, a wholly owned subsidiary of International Flavors & Fragrances Inc, (IFF)
Duration of Study in the UK
0 years, 7 months, 23 days
Research summary
The prevalence of metabolic syndrome is increasing significantly. Consumers are seeking new tools to support their metabolic health journey, specifically solutions that support blood glucose regulation. A growing body of evidence suggests probiotics may have an impact on glucose variability.
The aim of the trial is to find out the potential impact of a probiotic strain on well-being and metabolic health, including supporting healthy blood glucose levels, when taken as a daily dietary supplement.
Participants will be randomly allocated to receive either the high dose probiotic, low dose probiotic or placebo. We will monitor changes in blood glucose levels in all participants during the trial via a Continuous Glucose Monitoring (CGM) device over a period of 6 weeks. Most trial activities can be done by participants at home.
The trial will last for 10 weeks, and participants will take the trial product (high dose probiotic, low dose probiotic or placebo) via a daily capsule each morning for 6 weeks of this time. Participants will attend a central clinic on 3 occasions, at the start of the trial (baseline) and on weeks 6 and 8 for fasting blood samples.
At baseline and on weeks 6 and 8, participants will also be asked to collect at-home stool samples. They will also complete online surveys on their sleep quality, quality of life, physical activity and stool samples.
On a weekly basis, participants will be asked to complete an online survey to record whether they have taken the trial product and about any side-effects experienced since starting the trial. Participants will also complete a weekly food diary.
60 participants will be randomised in the trial. The research team will compare the effect of the probiotic against the placebo on a variety of outcomes, including glucose variability, microbiome structure and biomarkers.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0031
Date of REC Opinion
15 May 2025
REC opinion
Further Information Favourable Opinion