The Effects of a Postbiotic Supplement on Biomarkers of Gut Health

NCT07527286 | Completed

• 1 other identifier: VERB-0924-005
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal; Microbiota Balance; Microbiota; Cortisol; Butyrate; Bloating; Gastrointestinal Upset; Immuno-modulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will complete up to 5-week study consisting from screening, randomization, and enrollment periods to the end of treatment at 4 weeks

Secondary Outcomes (6)

• Evaluate the impact of a Postbiotic on short chain fatty acid production

  Participants will complete the trial from enrollment to the end of the 4-week treatment.

• Evaluate the impact of keystone postbiotic on serum zonulin

  Participants will complete the trial from enrollment to the end of the 4-week treatment.

• Evaluate the impact of keystone postbiotic on salivary cortisol.

  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

  Participants will complete the trial from enrollment to the end of the 4-week treatment.

• Evaluate the impact of keystone postbiotic on emotional state.

  Participants will complete the trial from enrollment to the end of the 4-week treatment.

Other Outcomes (1)

• Evaluate the safety and tolerability of keystone postbiotic through measurement of vital signs and adverse event recording.

  Participants will complete the trial from enrollment to the end of the 4-week treatment.

Study Arms (2)

Placebo Group

Participants who meet the study eligibility criteria will be randomly assigned to the study product or the placebo group. The study placebo will only contain maltodextrin.

Postbiotic Study Product

Participants who meet the study eligibility criteria will be randomly assigned to the study product or the placebo group. The study product will contain Keystone postbiotic and maltodextrin.

Dietary Supplement: Postbiotic

Interventions

Postbiotic DIETARY_SUPPLEMENT

300mg

Postbiotic Study Product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Apparently healthy men and women between 18 and 65 years old, located in Northeast Ohio.

You may qualify if:

• Provide voluntary signed and dated informed consent. • Be in good health as determined by medical history and routine blood chemistries.
• Age between 18 and 65 years (inclusive).
• Body Mass Index of 18.5-34.9 (inclusive).
• Body weight of at least 110 pounds.
• Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the participant will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
• Normal seated, resting heart rate (\<90 per minute).
• Willing to duplicate their previous 24-hour diet, refrain from caffeine for 24 hours, abstain from exercise for 48 hours prior, and fast for 10 hours prior to each laboratory visit.
• Participant agrees to maintain existing dietary and physical activity patterns throughout the study period.
• Participant is willing and able to comply with the study protocol.
• No medical history of gastrointestinal distress.
• Avoidance of cultured and fermented foods such as yogurt, kefir, kombucha during the duration of the study.

You may not qualify if:

• Current use of prebiotics, probiotics, postbiotics, or antibiotics within the past 4 weeks or use of any dietary supplement that may confound the study or its endpoints.
• Current use of GLP-1 inhibitors. • Individuals that adhere to a vegan diet.
• History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
• Current or previous diagnosis of prediabetes, diabetes, or an endocrine disorder.
• Fasting blood glucose of \> 125 mg/dL.
• Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
• Current smokers or smoking within the past month.
• Current use of aspirin, or pharmaceuticals impacting mucin such as, but not limited to Mucinex (guaifenesin).
• History of hyperparathyroidism or an untreated thyroid disease.
• History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• Prior gastrointestinal bypass surgery (Lapband), etc.
• Being treated for or having other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, IBS/IBD, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
• Chronic inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's disease, ulcerative colitis, IBS/IBD, Lupus, HIV/AIDS, etc.).
• Previous medical diagnosis of gout or fibromyalgia.
• Individuals who are cognitively impaired and/or who are unable to give informed consent.

Sponsors & Collaborators

• Verb Biotics LLC: lead

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

fecal, salivary, blood samples.

Study Officials

• Tim Ziegenfuss, Ph.D., FISSN, CSCS

  Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 14, 2026
• Study Start: November 5, 2024
• Primary Completion: April 26, 2025
• Study Completion: April 26, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)