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

NCT05820737 | Completed

• 1 other identifier: BR/221101/EFLP/GH
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 9

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

Conditions

Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  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

  Day 42 and Day 84

Secondary Outcomes (12)

• 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 Cytokine levels like IL-6.

  Day 42 and Day 84

Study Arms (3)

Placebo

PLACEBO COMPARATOR

1 capsule to be consumed once a day

Dietary Supplement: Placebo

EF2001

ACTIVE COMPARATOR

1 capsule to be consumed once a day

Dietary Supplement: EF2001

beLP1

ACTIVE COMPARATOR

1 capsule to be consumed once a day

Dietary Supplement: beLP1

Interventions

EF2001 DIETARY_SUPPLEMENT

One capsule to be consumed once a day

EF2001

beLP1 DIETARY_SUPPLEMENT

One capsule to be consumed once a day

beLP1

Placebo DIETARY_SUPPLEMENT

One capsule to be consumed once a day

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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
• Individuals experiencing moderate-intensity gastrointestinal symptoms, evaluated based on the combined scores of two GSRS domains (dyspeptic syndrome and bowel dysfunction), falling within the range of ≥ 15 and ≤ 29 over the past 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (9)

Dr. KotharisDigestive andLiver care

Pune, Maharashta, 411028, India

Location

AIIMS Hospital

Dombivali, Maharashtra, 421203, India

Location

Ramesh Dargad Clinic

Mumbai, Maharashtra, 400049, India

Location

Sarthak Health Clinic.

Nashik, Maharashtra, 422001, India

Location

Surya Multispeciality hospita

Nashik, Maharashtra, 422003, India

Location

Dr. Thakare superspeaciality clinic

Nashik, Maharashtra, 422008, India

Location

Life care Hospital

Nashik, Maharashtra, 422009, India

Location

Metabol

Ghātkopar, 400086, India

Location

Dhanwantari Hospita

Pune, 411002, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group, placebo controlled trial

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 20, 2023
• Study Start: April 14, 2024
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: June 25, 2025

Record last verified: 2024-01

Locations

IN (9)