The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in normal, overweight and obese individuals experiencing gut issues. Approximately 94 will be randomized into 1:1 ratio to either receive IP or Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
102
Apex Hospital
Ahmedabad, Gujarat, India
Aman Hospital and Research Centre
Vadodara, Gujarat, India
Hira Mongi Navneet Hospital
Mulund East, Maharashtra, India
Shantaee Nursing Home
Mumbai, Maharashtra, India
To assess efficacy of the Investigational Product (IP) on
Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein at day 56 from baseline.
Time frame: Day 56
To assess the effect of the of IP on Daily energy levels using Visual Analogue Scale - Fatigue
The respondents will be asked to denote the severity of their fatigue at the present moment by placing a mark on a line extending from "no fatigue" to "fatigue as bad as could be." Higher scores on the scale are indicative of more severe fatigue.
Time frame: Day 0,1,2,3,4,5,28 and 56
To assess the effect of the of IP on Fatigue Severity Scale (FSS)
The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 indicates strong agreement, and the final score represents the mean value of the 9 items.
Time frame: Day 0, 28 and 56
To assess the effect of the of IP on Immunomodulation using IFN-γ.
The serum levels of the IFNγ in healthy lean population was 10.83 ± 5.81 pg/ml and in obese population was 9.35 ± 5.14 pg/ml.
Time frame: Day 0, 28 and 56
To assess the effect of the of IP on Inflammation using TNF-α, IL-6 and IL-10
The recommended reference ranges of serum TNF-α is upto 10 pg/mL. The reported values for serum IL-6 in the blood of healthy individuals varied between 0 and 15 pg/ml. The detection ranges of IL-10 is 7.8 pg/ml to 500 pg/ml. The reported values for serum IL-10 in the blood of healthy controls upto 5 pg/ml.
Time frame: Day 0, 28 and 56
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Sangvi Multispeciality Hospital
Pune, Maharashtra, India
Lifepoint Multispeciality Hospital
Pune, Maharashtra, India
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, India
To assess the effect of the of IP on Stress as assessed by the change in the Perceived Stress Scale.
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Time frame: Day 0, 28 and 56
To assess the effect of the of IP on Quality of life using Digestive Associated Quality of Life Questionnaire (DQLQ).
The DQLQ includes 9 statements. 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 0, 28 and 56
To assess the effect of the of IP on Satiety as assessed by the change in the Three-Factor Eating Questionnaire-R18 (TFEQ-R18).
It is an 18 item questionnaire, where the responses are scored on a four-point scale (1 = definitely false, 2 = mostly false, 3 = mostly true, 4 = definitely true) and summed, except the question no. 18 where the scoring will be done on an eight-pointer scale. The higher score depicts the high degree of occurrence of the behavior, and higher levels of eating disturbances.
Time frame: Day 0, 28 and 56
To assess the effect of the of IP on Mood states using Mood and Feelings Questionnaire (MFQ)
Responses are rated on a 3-point scale. Total scores range from 0 to 26, with a score ≥12 commonly used in the literature to indicate clinically significant depression.
Time frame: Day 0, 28 and 56
To assess the effect of the of IP on Clinical Responders as assessed by the number of participants achieving normal stool consistency using Bristol stool form scale (BSFS).
A tool that categorises the stool into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhoea).
Time frame: Day 0 and 56
To assess the effect of the of IP on Gut microbiome diversity using
16s RNA sequencing
Time frame: Day 0 and 56