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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
standard food grade excipients
Target dose of 1x10\^10 CFU/day, plus standard food grade excipients
Atlantia Food Clinical Trials
Cork, Ireland
Change in BMI measurement
Significant change from week-zero to week-12 between active and placebo groups in percentage increase/decrease BMI
Time frame: From week-zero to week 12
Change in Waist:Hip ratio
Significant changes from week-zero to week 6 and 12 between active and placebo groups in waist:hip ratio
Time frame: Significant changes from week-zero to week 6 and 12
Change in serum insulin concentration
Significant changes from week-zero to week 6 and 12 between active and placebo groups in serum insulin concentration
Time frame: Significant changes from week-zero to week 6 and 12
Change in plasma HbA1c concentration
Significant changes from week-zero to week 6 and 12 between active and placebo groups in plasma HbA1c concentration
Time frame: Significant changes from week-zero to week 6 and 12
Change in plasma glucose concentration
Significant changes from week-zero to week 6 and 12 between active and placebo groups in plasma glucose concentration
Time frame: Significant changes from week-zero to week 6 and 12
Change in peripheral blood total cholesterol
Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood total cholesterol
Time frame: Significant changes from week-zero to week 6 and 12
Change in peripheral blood triglycerides
Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood total triglycerides
Time frame: Significant changes from week-zero to week 6 and 12
Change in peripheral blood HDL
Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood HDL
Time frame: Significant changes from week-zero to week 6 and 12
Change in peripheral blood direct LDL
Significant changes from week-zero to week 6 and 12 between active and placebo groups in peripheral blood direct LDL
Time frame: Significant changes from week-zero to week 6 and 12
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