Clinical trial NCT05820737: A Study to Assess the Gut Health Effects 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 Heat-killed Post-biotics EF2001 & beLP1 in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Dysfunction
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel group, placebo controlled trial
Primary purpose: OTHER

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


Eligibility criteria: 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:

  1. Individuals with ALT, AST values ≤ 2 times of the upper limit of normal (ULN).
  2. Individuals with creatinine values ≤ 1.5 times of the upper limit of normal (ULN).
  3. Individuals with ALP values ≥ 38 and ≤ 126 U/L
* Having at least two of the following five metabolic risk factors:

  1. Waist circumference \> 102 cm (40 inches) for men and \> 88 cm (35 inches) for women
  2. Fasting triglycerides \>150 mg/dL and \< 300 mg/dl
  3. Blood pressure ≥130 mm Hg (Systolic Blood Pressure) and/or ≥85 mm Hg (Diastolic Blood Pressure)
  4. Fasting blood glucose ≥ 100 mg/ dl
  5. 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

Primary outcomes:
measure: To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) from baseline.
timeFrame: Day 42
Secondary outcomes:
measure: To assess the impact of the IP from baseline as compared to placebo on Body Composition using Dual Energy X-ray Absorptiometry scan (DEXA)..
timeFrame: Day 42 and Day 84
measure: To assess the impact of the IP from baseline as compared to Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein (LBP).
timeFrame: Day 42 and Day 84
measure: To assess the impact of the IP from baseline as compared to placebo on Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)
timeFrame: Day 42 and Day 84
measure: To assess the impact of the IP from baseline as compared to placebo on Immunomodulation using INF-γ
timeFrame: Day 42 and Day 84
measure: To assess the impact of the IP from baseline as compared to placebo on Cytokine levels like IL-6.
timeFrame: Day 42 and Day 84
measure: 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)
timeFrame: Day 42 and Day 84
measure: To assess the impact of the IP from baseline as compared to placebo on Lipid profile: Total cholesterol, Triglyceride, HDL, LDL.
timeFrame: Day 42 and Day 84
measure: To assess the impact of the IP from baseline on Perceived Stress Scale (PSS)
timeFrame: Day 42 and Day 84
measure: To assess the impact of the IP from baseline as compared to placebo on Quality of life using Digestive Associated Quality of Life Questionnaire.
timeFrame: Day 42 and Day 84
measure: To assess the impact of the IP on change in the following parameters baseline on Short Chain Fatty Acids (SCFA)
timeFrame: Day 84
measure: 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.
timeFrame: Day 0 to Day 84
measure: 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.
timeFrame: Day 0 to Day 84
Other outcomes:
Locations:
city: Dombivli
country: India
facility: AIIMS Hospital
state: Maharashtra
city: Nashik
country: India
facility: Sarthak Health Clinic.
state: Maharashtra
city: Nashik
country: India
facility: Surya Multispeciality hospita
state: Maharashtra
city: Nashik
country: India
facility: Dr. Thakare superspeaciality clinic
state: Maharashtra
city: Nashik
country: India
facility: Life care Hospital
state: Maharashtra
city: Ghatkopar
country: India
facility: Metabol
city: Pune
country: India
facility: Dhanwantari Hospita
Study officials:
References: