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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
155
Dr. KotharisDigestive andLiver care
Pune, Maharashta, India
AIIMS Hospital
Dombivali, Maharashtra, India
Ramesh Dargad Clinic
Mumbai, Maharashtra, India
Sarthak Health Clinic.
Nashik, Maharashtra, India
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
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Body Composition using Dual Energy X-ray Absorptiometry scan (DEXA)..
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).
Time frame: 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).
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.
Time frame: 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)
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.
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Immunomodulation using INF-γ
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Surya Multispeciality hospita
Nashik, Maharashtra, India
Dr. Thakare superspeaciality clinic
Nashik, Maharashtra, India
Life care Hospital
Nashik, Maharashtra, India
Metabol
Ghātkopar, India
Dhanwantari Hospita
Pune, India
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
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Cytokine levels like IL-6.
IL-6 may be considered as a significant prognostic indicator of risk of any metabolic disorder.
Time frame: 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)
TNF levels were elevated in adipose tissue in obese and insulin-resistant rodents and suggested that TNF had a role in mediating insulin resistance
Time frame: 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.
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)
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline on Perceived Stress Scale (PSS)
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
To assess the impact of the IP from baseline as compared to placebo on Quality of life using Digestive Associated Quality of Life Questionnaire.
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.
Time frame: 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)
Short Chain Fatty Acids (SCFA)
Time frame: 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.
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
Time frame: 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.
Gut microbiome diversity using metagenome NGS sequencing of the fecal samples.
Time frame: Day 84