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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
90
Synbiotic \- Given daily for 56 days
Placebo \- Given daily for 56 days
Atlantia Clinical Trials Ltd
Cork, Blackpool, Ireland
RECRUITINGBifidobacterium 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.
Time frame: From baseline to end of intervention at 8 weeks
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.
Time frame: From baseline to end of intervention at 8 weeks
Fecal acetate
Change in fecal acetate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Time frame: From baseline to end of intervention at 8 weeks.
Fecal propionate
Change in fecal propionate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Time frame: From baseline to end of intervention at 8 weeks.
Fecal butyrate
Change in fecal butyrate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Time frame: From baseline to end of intervention at 8 weeks
Zonulin
Change in serum zonulin from baseline to 8 weeks
Time frame: From baseline to end of intervention at 8 weeks
Lipopolysaccharide binding protein (LPS-BP)
Change in plasma LPS-BP from baseline to 8 weeks
Time frame: From baseline to end of intervention at 8 weeks
Interleukin 6 (IL-6)
Change in serum IL-6 from baseline to 8 weeks
Time frame: From baseline to end of intervention at 8 weeks
High-sensitivity C-Reactive Protein (hsCRP)
Change in serum hsCRP from baseline to 8 weeks.
Time frame: From baseline to end of intervention at 8 weeks
Fecal Short-Chain Fatty Acids (SCFA)
Change in composite measurement of fecal SCFAs panel with targeted metabolomics (GC-MSMS) from baseline to 8 weeks. Total composite is defined as: acetate + propionate + butyrate.
Time frame: From baseline to end of intervention at 8 weeks
Stool consistency
Change in mean stool consistency assessed daily from 2 weeks prior to baseline to daily 2 weeks prior to end-of intervention. Stool consistency will be assessed by Bristol stool chart scale rated Type 1 (separate hard lumps) to Type 7 (watery, no solid pieces). An increase in stool consistency is desirable.
Time frame: From baseline to end of intervention at 8 weeks
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) score
Change in GSRS-IBS composite score from baseline to end-of-intervention visit. The GSRS-IBS questionnaire includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea and early satiety) during the last seven days. A decrease is desirable.
Time frame: From baseline to end of intervention at 8 weeks
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