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

Primary Purpose

Gastrointestinal Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
EF2001 (Low dose)
EF2001 (High dose)
beLP1 (Low dose)
beLP1 (High dose)
Placebo
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastrointestinal Dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shree Asirwad Hospital
  • AIIMS Hospital
  • Muktai Hospital
  • Surya Multispeciality Hospital
  • Life care Hospital
  • Dhanwantari Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

EF2001 (Low dose)

EF2001 (High dose)

beLP1 (Low dose)

beLP1 (High dose)

Arm Description

1 capsule to be consumed once a day

1 capsule to be consumed once a day

1 capsule to be consumed once a day

1 capsule to be consumed once a day

1 capsule to be consumed once a day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
To assess the impact of the IP at day 42 and day 84 from baseline on
Body Composition using DEXA
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).
To assess the impact of the IP at day 42 and day 84 from baseline on
Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)
To assess the impact of the IP at day 42 and day 84 from baseline on
Immunomodulation using INF-γ.
To assess the impact of the IP at day 42 and day 84 from baseline on
Cytokine levels like IL-6.
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)
To assess the impact of the IP at day 42 and day 84 from baseline on
Lipid profile: Total cholesterol, Triglyceride, HDL, LDL.
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.
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.
To assess the impact of the IP at day 84 from baseline on
Short Chain Fatty Acids (SCFA)
To assess the impact of the IP at day 84 from baseline on
Gut microbiome diversity using 16s RNA sequencing

Full Information

First Posted
April 6, 2023
Last Updated
June 6, 2023
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05820737
Brief Title
A Study to Assess the Gut Health Effects of High and Low Doses of Heat-killed Post-biotics in Overweight and Obese Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2, 2023 (Anticipated)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel group, placebo controlled trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 capsule to be consumed once a day
Arm Title
EF2001 (Low dose)
Arm Type
Active Comparator
Arm Description
1 capsule to be consumed once a day
Arm Title
EF2001 (High dose)
Arm Type
Active Comparator
Arm Description
1 capsule to be consumed once a day
Arm Title
beLP1 (Low dose)
Arm Type
Active Comparator
Arm Description
1 capsule to be consumed once a day
Arm Title
beLP1 (High dose)
Arm Type
Active Comparator
Arm Description
1 capsule to be consumed once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
EF2001 (Low dose)
Intervention Description
One capsule to be consumed once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
EF2001 (High dose)
Intervention Description
One capsule to be consumed once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
beLP1 (Low dose)
Intervention Description
One capsule to be consumed once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
beLP1 (High dose)
Intervention Description
One capsule to be consumed once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
One capsule to be consumed once a day
Primary Outcome Measure Information:
Title
To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) at day 84 from baseline.
Description
The GSRS scale score ranges from 0 to 45 where 0 means no intestinal issues and 45 means maximum intestinal issues.
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale at day 42 from baseline.
Description
The GSRS scale score ranges from 0 to 45 where 0 means no intestinal issues and 45 means maximum intestinal issues.
Time Frame
Day 42
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Body Composition using DEXA
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein (LBP).
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Immunomodulation using INF-γ.
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Cytokine levels like IL-6.
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Inflammation by assessing the levels of Tumor necrosis factor -alpha (TNF - α)
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Lipid profile: Total cholesterol, Triglyceride, HDL, LDL.
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 42 and day 84 from baseline on
Description
Quality of life using Digestive Associated Quality of Life Questionnaire.
Time Frame
Day 42 and Day 84
Title
To assess the impact of the IP at day 84 from baseline on
Description
Short Chain Fatty Acids (SCFA)
Time Frame
Day 84
Title
To assess the impact of the IP at day 84 from baseline on
Description
Gut microbiome diversity using 16s RNA sequencing
Time Frame
Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Shalini Srivastava, MBBS, MD
Phone
42172300
Ext
022
Email
shalini.s@vediclifesciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Henali Bhoir, B.Pharm
Phone
42172300
Ext
022
Email
henali.b@vediclifesciences.com
Facility Information:
Facility Name
Shree Asirwad Hospital
City
Dombivli
State/Province
Maharashtra
ZIP/Postal Code
421201
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Kushal Bangar, MBBS MD general medicine
Phone
9545664884
Ext
+91
Email
drkushal.bangar83@gmail.com
Facility Name
AIIMS Hospital
City
Dombivli
State/Province
Maharashtra
ZIP/Postal Code
421203
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Vineet Chaudhari, MD, MNAMS (GE)
Phone
7337422597
Ext
+91
Email
chaudhari.vineet@gmail.com
Facility Name
Muktai Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422001
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Chetan S Patil, MBBS, MD
Phone
9822651494
Ext
+91
Email
patilchetan@yahoo.com
Facility Name
Surya Multispeciality Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422003
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Prasad Nikam, MBBS, MD
Phone
9922999002
Ext
+91
Email
drprasadnresearch@gmail.com
Facility Name
Life care Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422009
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Namrata Modi, MBBS, DNB
Phone
7045103821
Ext
+91
Email
namratamodi11@gmail.com
Facility Name
Dhanwantari Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411002
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Bharat Jain, MBBS, DNB
Phone
8087448919
Ext
+91
Email
dr_bharatjain@rediffmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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