- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05820737
A Study to Assess the Gut Health Effects of Heat-killed Post-biotics in Overweight and Obese Adults
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Shalini Srivastava, MBBS, MD
- Phone Number: 022 42172300
- Email: shalini.s@vediclifesciences.com
Study Contact Backup
- Name: Henali Bhoir, B.Pharm
- Phone Number: 7738387606
- Email: henali.b@vediclifesciences.com
Study Locations
-
-
-
Ghatkopar, India, 400086
- Recruiting
- Metabol
-
Contact:
- Dr. Ketan Pakhale, MD General Medicine
- Phone Number: 9819704302
- Email: drketan.pakhale@metabolindia.com
-
Pune, India, 411002
- Not yet recruiting
- Dhanwantari Hospita
-
Contact:
- Dr. Bharat Jain, M.B.B.S, D.N.B
- Phone Number: 8087448919
- Email: dr_bharatjain@rediffmail.com
-
-
Maharashtra
-
Dombivli, Maharashtra, India, 421203
- Recruiting
- AIIMS Hospital
-
Contact:
- Dr. Vineet Chaudhari, MD, MNAMS (GE)
- Phone Number: 7337422597
- Email: chaudhari.vineet@gmail.com
-
Nashik, Maharashtra, India, 422009
- Recruiting
- Life care Hospital
-
Contact:
- Dr. Namrata Modi, MBBS, DNB
- Phone Number: 7045103821
- Email: namratamodi11@gmail.com
-
Nashik, Maharashtra, India, 422001
- Not yet recruiting
- Sarthak Health Clinic.
-
Contact:
- Dr. Ashutosh Sonawane, MBBS, MD, DM
- Phone Number: 8828226607
- Email: drashutoshsonawane@gmail.com
-
Nashik, Maharashtra, India, 422003
- Recruiting
- Surya Multispeciality hospita
-
Contact:
- Dr. Prasad Nikam, M.B.B.S, MD
- Phone Number: 9922999002
- Email: drprasadnresearch@gmail.com
-
Nashik, Maharashtra, India, 422008
- Not yet recruiting
- Dr. Thakare superspeaciality clinic
-
Contact:
- Dr. Mahesh Thakare, MBBS,MD
- Phone Number: 7822821643
- Email: mahesh131090@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
- 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.
- Willing to abstain from other supplements or medication.
- Ready to give voluntary, written, informed consent to participate in the study
- No prohibited 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 not less than that reported at screening. (The highest score out of two weeks' GSRS scores will be taken into consideration for the study)
- Both the weekly at-home diaries for GSRS should be available
- 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 > 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.
- 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 18. 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
1 capsule to be consumed once a day
|
One capsule to be consumed once a day
|
Active Comparator: EF2001
1 capsule to be consumed once a day
|
One capsule to be consumed once a day
|
Active Comparator: beLP1
1 capsule to be consumed once a day
|
One capsule to be consumed once a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) from baseline.
Time Frame: Day 42
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the impact of the IP from baseline as compared to placebo on Body Composition using Dual Energy X-ray Absorptiometry scan (DEXA)..
Time Frame: Day 42 and Day 84
|
The overall body composition (Lean Body Mass, Body Fat percent, Fat Free Mass, android and gynoid fat) will be evaluated 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).
Time Frame: Day 42 and Day 84
|
The amount of the LBP will be calculated based on the standard curve.
A study demonstrated an average of 7.8 μg/mL of LBP in obese individuals and 6 μg/mL in normal weight individuals.
|
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)
Time Frame: Day 42 and Day 84
|
HOMA-IR = (Fasting glucose × Insulin levels) ÷ 40 In a clinical study, subjects without metabolic syndrome exhibited a HOMA-IR value of 2.39, whereas obese subjects showed a higher HOMA-IR of 4.04.
|
Day 42 and Day 84
|
To assess the impact of the IP from baseline as compared to placebo on Immunomodulation using INF-γ
Time Frame: Day 42 and Day 84
|
In the current study, the impact of the heat killed postbiotics will be evaluated in enhancing the immune-modulatory characteristics in individuals under metabolic stress
|
Day 42 and Day 84
|
To assess the impact of the IP from baseline as compared to placebo on Cytokine levels like IL-6.
Time Frame: Day 42 and Day 84
|
IL-6 may be considered as a significant prognostic indicator of risk of any metabolic disorder.
|
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)
Time Frame: Day 42 and Day 84
|
TNF levels were elevated in adipose tissue in obese and insulin-resistant rodents and suggested that TNF had a role in mediating insulin resistance
|
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.
Time Frame: Day 42 and Day 84
|
The Lipid Profile will be performed on Roche cobas, Desirable cholesterol level is < 5.17 mmol/L (< 200 mg/dL).
Desirable HDL level is > 1.68 mmol/L (> 65 mg/dL) in females & > 1.45 mmol/L (> 55 mg/dL) in males.
Normal range of triglycerides is < 1.70 mmol/L (< 150 mg/dL)
|
Day 42 and Day 84
|
To assess the impact of the IP from baseline on Perceived Stress Scale (PSS)
Time Frame: Day 42 and Day 84
|
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 from baseline as compared to placebo on Quality of life using Digestive Associated Quality of Life Questionnaire.
Time Frame: Day 42 and Day 84
|
Quality of life using Digestive Associated Quality of Life Questionnaire., The total score represents the sum of the responses to the 9 statements with possible scores ranging from 0 to 9. A higher score indicates a lower (worse) digestion-associated QOL.
|
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)
Time Frame: Day 84
|
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.
Time Frame: Day 0 to Day 84
|
Th1 cells secrete the cytokine interferon-gamma and activate inflammatory pathways mainly via macrophage activation .Th2 cells secrete cytokines interleukin-4 and -5 that upregulate antibody formation via B cells, mast cells, eosinophils, and other pathways.
Th1 and Th2 cells can cross-inhibit each other
|
Day 0 to 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.
Time Frame: Day 0 to Day 84
|
Gut microbiome diversity using metagenome NGS sequencing of the fecal samples.
|
Day 0 to Day 84
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BR/221101/EFLP/GH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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