A Study to Assess the Gut Health Effects of High and Low Doses of Heat-killed Post-biotics in Overweight and Obese Adults

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

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

Conditions
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Gastrointestinal Dysfunction

Intervention / Treatment
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* Dietary Supplement: EF2001 (Low dose)
* Dietary Supplement: EF2001 (High dose)
* Dietary Supplement: beLP1 (Low dose)
* Dietary Supplement: beLP1 (High dose)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female individuals with the age ≥18 and ≤65 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 Normal liver & renal function as defined below: Individuals with ALT values ≥ 9 and ≤ 52 U/L in females and ≥ 21 and ≤ 72 U/L in males. Individuals with AST values ≥ 14 and ≤ 36 U/L in females and ≥ 17 and ≤ 59 U/L in males Individuals with Creatinine ≥ 46 and ≤ 92 μmol/L in females and ≥ 58 and ≤110 μmol/L in males 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) Fasting blood glucose ≥ 100 mg/ dl Fasting HDL cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) History of mild to moderate gastrointestinal discomfort for at least last three months GSRS scores of ≥ 10 and ≤ 29 for last two weeks. (The highest score out of two weeks' GSRS scores will be taken into consideration for the study) Willing to complete all study procedures including study-related questionnaires and comply with study requirements. Willing to abstain from other supplements or medication. Ready to give voluntary, written, informed consent to participate in the study No antibiotic usage within the last 30 days. History of stable weight over the last 6 months (<10% change) Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol Randomization Criteria: Two weeks of run - in period for weight stability (Weight instability defined as > 2 kg of weight gain or loss over 2 weeks of run-in period) GSRS scores of ≥ 10 and ≤ 29 for last two weeks. (The highest score out of two weeks' GSRS scores will be taken into consideration for the study) 80% compliance to the run-in medication 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 > 126 mg/dl Individuals diagnosed with hypertension and are on active medication Individuals with uncontrolled hypertension with systolic blood pressure ≥160 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 participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk. Individuals under use of any psychotropic medication within four weeks of screening and throughout the study. Individuals 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 Individual states they regularly consume supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes. Individuals states they regularly consume probiotic supplements and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental probiotics may include standalone probiotic supplements, vitamins with probiotics, and any foods supplemented with probiotics Exposure to any non-registered drug product within 3 months prior to the screening visit. Unable/unwillingness to complete study specific diaries (digital/paper-based). Current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/ dietary supplement. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. Individual who reports alcohol intake as average of 3 or more servings per day Individuals with thyroid dysfunction as assessed by TSH ≤ 0.4 or ≥ 4.3 mIU/L. Individuals state they have an allergy or intolerance to any ingredient in the study product or test meal. Individual is deemed unsuitable for study based upon study physician assessment. Individual is taking part in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel group, placebo controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>1 capsule to be consumed once a day | Dietary Supplement: Placebo<br>* One capsule to be consumed once a day<br>|
| Active Comparator: EF2001 (Low dose)<br>1 capsule to be consumed once a day | Dietary Supplement: EF2001 (Low dose)<br>* One capsule to be consumed once a day<br>|
| Active Comparator: EF2001 (High dose)<br>1 capsule to be consumed once a day | Dietary Supplement: EF2001 (High dose)<br>* One capsule to be consumed once a day<br>|
| Active Comparator: beLP1 (Low dose)<br>1 capsule to be consumed once a day | Dietary Supplement: beLP1 (Low dose)<br>* One capsule to be consumed once a day<br>|
| Active Comparator: beLP1 (High dose)<br>1 capsule to be consumed once a day | Dietary Supplement: beLP1 (High dose)<br>* One capsule to be consumed once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) at day 84 from baseline. | The GSRS scale score ranges from 0 to 45 where 0 means no intestinal issues and 45 means maximum intestinal issues. | Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale at day 42 from baseline. | The GSRS scale score ranges from 0 to 45 where 0 means no intestinal issues and 45 means maximum intestinal issues. | Day 42 | 
| To assess the impact of the IP at day 42 and day 84 from baseline on | Body Composition using DEXA | Day 42 and Day 84 | 
| To assess the impact of the IP at day 42 and day 84 from baseline on | Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein (LBP). | Day 42 and Day 84 | 
| To assess the impact of the IP at day 42 and day 84 from baseline on | Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR) | Day 42 and Day 84 | 
| To assess the impact of the IP at day 42 and day 84 from baseline on | Immunomodulation using INF-γ. | Day 42 and Day 84 | 
| To assess the impact of the IP at day 42 and day 84 from baseline on | Cytokine levels like IL-6. | Day 42 and Day 84 | 
| To assess the impact of the IP at day 42 and day 84 from baseline 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 at day 42 and day 84 from baseline on | Lipid profile: Total cholesterol, Triglyceride, HDL, LDL. | Day 42 and Day 84 | 
| To assess the impact of the IP at day 42 and day 84 from baseline on | Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | Day 42 and Day 84 | 
| To assess the impact of the IP at day 42 and day 84 from baseline on | Quality of life using Digestive Associated Quality of Life Questionnaire. | Day 42 and Day 84 | 
| To assess the impact of the IP at day 84 from baseline on | Short Chain Fatty Acids (SCFA) | Day 84 | 
| To assess the impact of the IP at day 84 from baseline on | Gut microbiome diversity using 16s RNA sequencing | Day 84 |