Bloating, Butyrate, Cortisol, Gastrointestinal, Gastrointestinal Upset, Immuno-modulation, Microbiota, Microbiota Balance
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPostbiotic
300mg
Sponsors
Verb Biotics LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. • Pregnant, trying to become pregnant, less than 120 days postpartum, or are nursing. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent. • Clinically significant abnormal laboratory results at screening. • Known sensitivity to any ingredient in the test formulations as listed in the study product. • Currently participating in another research study with an investigational product or have been in another research study in the past 30 days. • Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the participant at increased risk of harm if they were to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the change in fecal microbiome diversity. | Participants will complete up to 5-week study consisting from screening, randomization, and enrollment periods to the end of treatment at 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Evaluate the impact of keystone postbiotic on serum zonulin | Participants will complete the trial from enrollment to the end of the 4-week treatment. | 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. |
| Evaluate the impact of keystone postbiotic on salivary cortisol. | Participants will complete the trial from enrollment to the end of the 4-week treatment. | 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. |
| 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. | 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. |
| Evaluate the impact of keystone postbiotic on emotional state. | Participants will complete the trial from enrollment to the end of the 4-week treatment. | 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. |
| Evaluate the impact of keystone postbiotic on gastointestinal health | Participants will complete the trial from enrollment to the end of the 4-week treatment. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTim Ziegenfuss, Ph.D., FISSN, CSCS
Center for Applied Health Sciences
Outcome results
None listed