This study is a randomized, double-blind, two-arm, placebo-controlled trial of N=80 (40/arm) apparently healthy men and women between 18 and 65 years old to be recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). This study will assess the effectiveness of a postbiotic supplement on various biomarkers of health. Consumption of this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease. Participants will attend three in-person study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet). Over the next 4 weeks, participants will attend two in-person visits: \[visit 2 (week 0) and visit 3 (week 4)\] wherein assessments of gut function \[fecal microbiome diversity, short chain fatty acids (SCFA), and fecal butyrate\], serum butyrate, serum zonulin, salivary cortisol, and Gastrointestinal Symptom Rating Scale (GSRS) for gastrointestinal (GI) health, emotional states \[Depression, Anxiety and Stress Scale (DASS21)\], and quality of life (SF-36 questionnaire) will be assessed. Participants will also be provided home kits with instructions on how to collect stool and saliva samples on two separate occasions (i.e., visit 2, visit 3) during the study. • Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure participant safety and scientific integrity of the data.
Study Type
OBSERVATIONAL
Enrollment
76
300mg
The Center for Applied Health Sciences
Canfield, Ohio, United States
Evaluate the change in fecal microbiome diversity.
The primary outcome is to observe a change in the fecal microbial populations in between the postbiotic group and the placebo control group from intake and baseline to the end of the study period. This will be measured by a change in fecal microbial populations by DNA analysis at the genus, species and strain level (where possible) between the placebo and study group. Baseline period will be compared as well. Both alpha and beta diversity will be assessed as well.
Time frame: Participants will complete up to 5-week study consisting from screening, randomization, and enrollment periods to the end of treatment at 4 weeks
Evaluate the impact of a Postbiotic on short chain fatty acid production
A secondary outcome is to evaluate the impact of keystone postbiotic on short chain fatty acid production. This will be measured by a change in the SCFA profile in fecal samples as assessed by GC/MS, between placebo control group and the postbiotic group. Blood samples will also be taken to evaluate circulating butyrate levels between placebo control group and the postbiotic group. GCMS detection is determined by peak area values. Higher values at the end of the trial suggest more SCFA are being produced.
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on serum zonulin
A secondary outcome is to evaluate the impact of keystone postbiotic on serum zonulin. This will be measured by a change in numerical value of zonulin (ng/ml) between the placebo and study group as well as a change from baseline to the end of the study at 4-weeks. Higher values of serum zonulin suggest increased permeability of the intestinal epithelium.
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on salivary cortisol.
A secondary outcome is to evaluate the impact of the postbiotic on salivary cortisol as a measure of stress. This will be measured by a change in salivary cortisol (ug/dL) between placebo and study product group. Baseline period will be assessed as well. Higher levels of salivary cortisol suggest more stress (physical, immune related or psychological) which is a worse outcome.
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on Quality of Life
A secondary outcome will be measured by a change in the SF-36 (36-Item Short Form Survey) score between placebo and study product group to assess quality of life. Baseline period will be compared as well. On a scale between 0-100, a higher SF-36 score indicates better health.
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on emotional state.
A secondary outcome is to evaluate the impact of the postbiotic on emotional health. This will be assessed by a change in the DASS-21 (depression, anxiety and stress -21 items) assessment. On a scale between 0-42, a higher DASS-21 score indicates more severe emotional distress, which is a worse outcome.
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on gastointestinal health
A secondary outcome is to evaluate the impact of the postbiotic on gastrointestinal health. This will be measured by a change in the GSRS (gastrointestinal symptoms rating scale) score between placebo and study product groups. Baseline period will be compared as well. On a scale of 15-105, a higher GSRS score indicates more severe symptoms, which is a worse outcome.
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
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