A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Gut Health Effects of Heat-killed Post-biotics EF2001 & beLP1 in Overweight and Obese Adults

Vedic Lifesciences Pvt. Ltd.9 sites in 1 country155 target enrollmentApril 14, 2024

ConditionsGastrointestinal Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastrointestinal Dysfunction
Sponsor: Vedic Lifesciences Pvt. Ltd.
Enrollment: 155
Locations: 9
Primary Endpoint: To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) from baseline.
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is a randomized, double-blind (Double dummy), placebo-controlled, parallel-group study to assess the gut health effects of heat-killed post biotics in overweight and obese individuals

Registry

clinicaltrials.gov

Start Date

April 14, 2024

End Date

March 24, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vedic Lifesciences Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female individuals with the age ≥18 and ≤45 years with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF - SF)
•BMI of ≥ 25 - ≤ 35 kg/m2
•Individuals with liver \& renal function test values as defined below:
•Individuals with ALT, AST values ≤ 2 times of the upper limit of normal (ULN).
•Individuals with creatinine values ≤ 1.5 times of the upper limit of normal (ULN).
•Individuals with ALP values ≥ 38 and ≤ 126 U/L
•Having at least two of the following five metabolic risk factors:
•Waist circumference \> 102 cm (40 inches) for men and \> 88 cm (35 inches) for women
•Fasting triglycerides \>150 mg/dL and \< 300 mg/dl
•Blood pressure ≥130 mm Hg (Systolic Blood Pressure) and/or ≥85 mm Hg (Diastolic Blood Pressure)

Exclusion Criteria

•Individual who smokes and consumes tobacco regularly.
•Presence of unstable, acutely symptomatic, or life-limiting illness.
•Individuals diagnosed with diabetes and are on active medication
•FBG \> 125 mg/dl
•Individuals diagnosed with hypertension and are on active medication.
•Individuals with uncontrolled hypertension with systolic blood pressure ≥150 and/or diastolic blood pressure ≥100 mm Hg.
•Individuals with neurological conditions causing functional or cognitive impairments.
•Individuals with a history or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
•Individuals under use of any psychotropic medication within four weeks of screening and throughout the study
•Individual under use of antibiotics or signs of active systemic infection at the time of screening. Treatment visits will be rescheduled to allow the subject to wash off the antibiotic for at least five days prior to any test visit

Outcomes

Primary Outcomes

To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) from baseline.

Time Frame: Day 42 and Day 84

Questions are to be rated on a Likert scale ranging from no discomfort at all (0) to very severe discomfort (3). A total score is calculated by summing the ratings provided on all questions. The questionnaire has 18 items - epigastric pain, colicky pain, dull pain, undefined pain, heartburn, acid regurgitation, sucking sensation, nausea and vomiting, borborygmus, abdominal distension, eructation, increased flatus, decreased passage of stools, increased passage of stools, loose stools, hard stools, urgent need for defecation and feeling of incomplete evacuation

Secondary Outcomes

To assess the impact of the IP from baseline as compared to placebo on Cytokine levels like IL-6.(Day 42 and Day 84)
To assess the impact of the IP from baseline as compared to placebo on Body Composition using Dual Energy X-ray Absorptiometry scan (DEXA)..(Day 42 and Day 84)
To assess the impact of the IP from baseline as compared to Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein (LBP).(Day 42 and Day 84)
To assess the impact of the IP from baseline as compared to placebo on Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)(Day 42 and Day 84)
To assess the impact of the IP from baseline as compared to placebo on Immunomodulation using INF-γ(Day 42 and Day 84)
To assess the impact of the IP from baseline as compared to placebo on Inflammation by assessing the levels of Tumor necrosis factor -alpha (TNF - α)(Day 42 and Day 84)
To assess the impact of the IP from baseline as compared to placebo on Lipid profile: Total cholesterol, Triglyceride, HDL, LDL.(Day 42 and Day 84)
To assess the impact of the IP from baseline on Perceived Stress Scale (PSS)(Day 42 and Day 84)
To assess the impact of the IP from baseline as compared to placebo on Quality of life using Digestive Associated Quality of Life Questionnaire.(Day 42 and Day 84)
To assess the impact of the IP on change in the following parameters baseline on Short Chain Fatty Acids (SCFA)(Day 84)
To assess the impact of the IP on change in the following parameters from baseline on Humoral response as assessed by Th1/Th2 in plasma.(Day 84)
To assess the impact of the IP on change in the following parameters from baseline on Gut microbiome diversity using metagenome NGS sequencing of the fecal samples.(Day 84)