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

Sponsor

Vedic Lifesciences Pvt. Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05820737

Collaborator

(none)

156

Enrollment

Locations

Arms

10.4

Anticipated Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Dysfunction	Dietary Supplement: EF2001 (Low dose) Dietary Supplement: EF2001 (High dose) Dietary Supplement: beLP1 (Low dose) Dietary Supplement: beLP1 (High dose) Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, parallel group, placebo controlled trialRandomized, parallel group, placebo controlled trial

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

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

Anticipated Study Start Date :

May 2, 2023

Anticipated Primary Completion Date :

Mar 15, 2024

Anticipated Study Completion Date :

Mar 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 1 capsule to be consumed once a day	Dietary Supplement: Placebo One capsule to be consumed once a day
Active Comparator: EF2001 (Low dose) 1 capsule to be consumed once a day	Dietary Supplement: EF2001 (Low dose) One capsule to be consumed once a day
Active Comparator: EF2001 (High dose) 1 capsule to be consumed once a day	Dietary Supplement: EF2001 (High dose) One capsule to be consumed once a day
Active Comparator: beLP1 (Low dose) 1 capsule to be consumed once a day	Dietary Supplement: beLP1 (Low dose) One capsule to be consumed once a day
Active Comparator: beLP1 (High dose) 1 capsule to be consumed once a day	Dietary Supplement: beLP1 (High dose) One capsule to be consumed once a day

Outcome Measures

Primary Outcome Measures

To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) at day 84 from baseline. [Day 84]

Secondary Outcome Measures

To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) at day 42 from baseline. [Day 42]
To assess the impact of the IP at day 42 and day 84 from baseline on [Day 42 and Day 84]
Body Composition using DEXA
To assess the impact of the IP at day 42 and day 84 from baseline on [Day 42 and Day 84]
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 [Day 42 and Day 84]
Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)
To assess the impact of the IP at day 42 and day 84 from baseline on [Day 42 and Day 84]
Immunomodulation using INF-γ.
To assess the impact of the IP at day 42 and day 84 from baseline on [Day 42 and Day 84]
Cytokine levels like IL-6.
To assess the impact of the IP at day 42 and day 84 from baseline on [Day 42 and Day 84]
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 [Day 42 and Day 84]
Lipid profile: Total cholesterol, Triglyceride, HDL, LDL.
To assess the impact of the IP at day 42 and day 84 from baseline on [Day 42 and Day 84]
Perceived Stress Scale (PSS)
To assess the impact of the IP at day 42 and day 84 from baseline on [Day 42 and Day 84]
Quality of life using Digestive Associated Quality of Life Questionnaire.
To assess the impact of the IP at day 84 from baseline on [Day 84]
Short Chain Fatty Acids (SCFA)
To assess the impact of the IP at day 84 from baseline on [Day 84]
Gut microbiome diversity using 16s RNA sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shree Asirwad Hospital	Dombivli	Maharashtra	India	421201
2	AIIMS Hospital	Dombivli	Maharashtra	India	421203
3	Muktai Hospital	Nashik	Maharashtra	India	422001
4	Surya Multispeciality Hospital	Nashik	Maharashtra	India	422003
5	Life care Hospital	Nashik	Maharashtra	India	422009
6	Dhanwantari Hospital	Pune	Maharashtra	India	411002

Sponsors and Collaborators

Vedic Lifesciences Pvt. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vedic Lifesciences Pvt. Ltd.

ClinicalTrials.gov Identifier:

NCT05820737

Other Study ID Numbers:

BR/221101/EFLP/GH

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 20, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Apr 20, 2023