The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic.
The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.
Be able to give informed consent.
Be between 50 to 70 years of age (inclusive).
BMI ranging from 25.0 and 35.0 kg/m²
Willing to maintain current level of physical activity and diet during the participation in the study.
Has a history of drug and/or alcohol abuse.
Has food allergies, or other issues with foods, that would preclude intake of the study products.
Smoking, chewable tobacco and/or vaping and/or use of other nicotine products.
diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome (IBS)
Parallel
Synbiotic
Dietary supplementSynbiotic \- Given daily for 56 days
Placebo
Dietary supplementPlacebo \- Given daily for 56 days
Bifidobacterium abundance
Change in total relative abundance of Bifidobacterium from baseline to 8 weeks assessed from fecal samples. Abundance is calculated based on shotgun metagenomic sequencing.
Stool frequency
Change in number of daily bowel movements from 2 weeks average prior to baseline to 2 weeks average prior to end of intervention. An increase is desirable.
Fecal acetate
Change in fecal acetate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Fecal propionate
Change in fecal propionate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Fecal butyrate
Change in fecal butyrate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Recovery of probiotic strains
Recovery and colonization of strains by strain specific qPCR of fecal samples
Total relative abundance of Bifidobacterium
Change in total relative abundance of Bifidobacterium after 2 weeks of follow-up (no intervention) compared to effect after 3 weeks and 8 weeks of intervention.
Microbiome composition and taxonomic profiles
Changes in gut microbiome composition and taxonomic profiling analyzed by shotgun metagenomic sequencing of fecal samples
Microbiome functional profiling
Change in gut microbiome functional profiling analyzed by shotgun metagenomic sequencing of fecal samples
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