A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults

Vedic Lifesciences Pvt. Ltd.7 sites in 1 country102 target enrollmentApril 4, 2023

ConditionsGut Health

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gut Health
Sponsor: Vedic Lifesciences Pvt. Ltd.
Enrollment: 102
Locations: 7
Primary Endpoint: To assess efficacy of the Investigational Product (IP) on
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 4, 2023

End Date

March 20, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vedic Lifesciences Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects with the age ≥18 and ≤60 years with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF)
•BMI of ≥ 18 - ≤ 34.9 kg/m2
•Having at least three 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
•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)
•SGOT, SGPT ≤ 2 times the upper normal limit.
•Creatinine levels ≤ 1.5 times the upper normal limit.

Exclusion Criteria

•Pure vegetarians who do not consume chicken, fish and/or egg.
•Presence of unstable, acutely symptomatic, or life-limiting illness.
•Subjects with uncontrolled hypertension with systolic blood pressure ≥160 and diastolic blood pressure ≥100 mm Hg.
•Subjects with uncontrolled Type II Diabetes Mellitus with FBG ≥ 126 mg/ dl
•Neurological conditions causing functional or cognitive impairments.
•Unwillingness or inability to be randomized to one of two intervention groups.
•Bilateral hip replacements.
•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 participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.
•History or presence of Irritable Bowel Syndrome as per Rome IV criteria. \[Diagnostic criteria\* Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
•Related to defecation.

Outcomes

Primary Outcomes

To assess efficacy of the Investigational Product (IP) on

Time Frame: Day 56

Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein at day 56 from baseline.

Secondary Outcomes

To assess the effect of the of IP on Gut microbiome diversity using(Day 0 and 56)
To assess the effect of the of IP on Inflammation using TNF-α, IL-6 and IL-10(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).(Day 0 and 56)
To assess the effect of the of IP on Daily energy levels using Visual Analogue Scale - Fatigue(Day 0,1,2,3,4,5,28 and 56)
To assess the effect of the of IP on Fatigue Severity Scale (FSS)(Day 0, 28 and 56)
To assess the effect of the of IP on Immunomodulation using IFN-γ.(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).(Day 0, 28 and 56)
To assess the effect of the of IP on Mood states using Mood and Feelings Questionnaire (MFQ)(Day 0, 28 and 56)
To assess the effect of the of IP on Stress as assessed by the change in the Perceived Stress Scale.(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).(Day 0, 28 and 56)