NCT04042181

The Effects of Supplementation of a Probiotic, B. Longum, on BMI and Anthropometric Outcomes in Overweight/Obese Adults.

A Randomised, Double-blinded, Parallel, Placebo-controlled Study to Evaluate the Effects of 12-weeks Supplementation of a Probiotic, Bif. Longum, on BMI and Anthropometric Outcomes in Overweight/Obese Adults.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: University College Cork · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Obesity levels worldwide have tripled since the mid 1070's. Obesity and its co-morbidities, metabolic syndrome, type II diabetes, and cardiovascular disease, are serious widespread health concerns which urgently need to be addressed. G protein-coupled receptors (GPCRs), such as the ghrelin receptor (GHS-R1a), are well known for their key role in the homeostatic control of food intake and energy balance. Ghrelin is the major hunger hormone in the body and ghrelin-receptor antagonists have been advanced as potential anti-obesity agents. This receptor is therefore an ideal target for orally delivered probiotic-derived bioactives with excellent bioavailability. Bacterial strains with the ability to modulate these receptors may have high potential as probiotics with the ability to induce appetite modulation effects. Due to promising pre-clinical results, the investigators aim to trial a Bif Longum probiotic, which can target these receptors, in an obese human population. We hypothesise that the probiotic will positively alter the gut-brain axis, improving control of hunger and satiety signalling adults with high BMI, leading to decreased BMI and waist-hip ratio scores. Furthermore, the investigators expect that the mechanism through which the probiotic is having a positive impact can be determined via investigation of the microbiota composition, gut hormone levels and circulating immune profiles.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	standard food grade excipients
DIETARY_SUPPLEMENT	Bifidobacterium longum	Target dose of 1x10\^10 CFU/day, plus standard food grade excipients

Timeline

• Start date: 2018-07-09
• Primary completion: 2018-12-21
• Completion: 2019-12-30
• First posted: 2019-08-01
• Last updated: 2019-08-01

Locations

1 site across 1 country: Ireland