A study to assess the gut health effects of Oil Compound on healthy adults
- Registration Number
- CTRI/2023/03/050679
- Lead Sponsor
- Vedic Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
1 Male and female subjects with the age more than equal to 18 and less than equal to 60 years with active lifestyle, moderate physical activity level as per International Physical Activity
Questionnaire Short Form (IPAQ SF)
2 BMI more than equal to 18 and less than equal to 34.9 kg per m2
3 Having at least three of the following five metabolic risk factors
a Waist circumference more than 102 cm (40 inches) for men and more than 88 cm (35
inches) for women
b Fasting triglycerides more than 150 mg per dL
c Blood pressure more than equal to 130 mm Hg (Systolic Blood Pressure) and or more than equal to 85 mm Hg (Diastolic Blood Pressure)
d Fasting blood glucose more than equal to 100 mg per dl
e Fasting HDL cholesterol level less than 40 mg per dl (men) or 50 mg per dl (women)
4 SGOT, SGPT less than equal to 2 times the upper normal limit
5 Creatinine levels less than equal to 1.5 times the upper normal limit
6 Willing to complete all study procedures including study related questionnaires and comply with study requirements
7 Willing to abstain from other supplements or medication
8 Ready to give voluntary, written, informed consent to participate in the study
9 Evidence of abnormal stool consistency (at least one day every week indicating constipation or diarrhoea) as determined by Bristol Stool Scale
in the last 3 months
10 No self reported physical or mental disabilities or gastrointestinal conditions
11 No antibiotic usage within the last 30 days
12 History of stable weight over the last 6 months (less than 10 percent change)
13 Willing to maintain current dietary and exercise habits, aside from any
changes to be made per the study exercise protocol
1 Pure vegetarians who do not consume chicken, fish and/or egg
2 Smokers
3 Presence of unstable, acutely symptomatic, or life limiting illness
4 Subjects with uncontrolled hypertension with systolic blood pressure more than equal to 160 and diastolic blood pressure more than equal to 100 mm Hg.
5 Subjects with uncontrolled Type II Diabetes Mellitus with FBG more than equal to 126 mg per dl
6 Neurological conditions causing functional or cognitive impairments
7 Unwillingness or inability to be randomized to one of two intervention groups
8 Bilateral hip replacements
9 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 participants 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
10 History or presence of Irritable Bowel Syndrome as per Rome IV criteria
Diagnostic criteria
Recurrent abdominal pain on average at least 1 day per week in the last 3 months, associated with two or more of the following criteria
1 Related to defecation
2 Associated with a change in frequency of stool
3 Associated with a change in form appearance of stool
Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
10 Use of any psychotropic medication within four weeks of screening and throughout the study.
11 Use of antibiotics or signs of active systemic infection at the time of screening. Treatment visits will be rescheduled to the subject to wash off the antibiotic for at least five days prior to any test visit.
12 Subject 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
13 Subject states they regularly consume probiotic, prebiotic, energy and
mood enhancing supplements 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
14 Subject states they are currently being prescribed (by primary care physician or other health professional) medication or using an over the counter product that in the opinion of the study physician will have an effect on food digestion or nutrient absorption during the study
15 Exposure to any non registered drug product within 3 months prior to the screening visit
16 Unable or unwillingness to complete study specific diaries (digital or paper based)
17 Current use of the following medications monoamine oxidase inhibitors, prescription or herbal weight loss medications or dietary supplement
18 Females who are pregnant or planning to be pregnant/lactating or taking any oral contraceptives
19 Heavy alcohol drinkers defined as follows
For men, consuming more than 4 drinks on any day or more than 14 drinks per week
For women, consuming more than 3 drinks on any day or more than 7 drinks per week
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess efficacy of the Investigational Product (IP) on gut permeability by assessing the levels of Lipopolysaccharide Binding Protein at day 56 from baseline. <br/ ><br>Timepoint: Day 0 and Day 56
- Secondary Outcome Measures
Name Time Method Clinical Responders as assessed by the number of participants achieving <br/ ><br>normal stool consistency using Bristol stool form scale (BSFS).Timepoint: Day 0 and 56;Daily energy levels using Visual Analogue Scale – Fatigue and <br/ ><br>Fatigue Severity Scale (FSS)Timepoint: Visual Analogue Scale – Fatigue - Day0,1,2,3,4,5,28 and 56 <br/ ><br>Fatigue Severity Scale- Day 0, 28 and 56;Gut microbiome diversity using 16s RNA sequencingTimepoint: Day 0 and 56;Immunomodulation using IFN-?Timepoint: Day 0, 28 and 56;Inflammation using TNF-a, IL-6 and IL-10Timepoint: Day 0, 28 and 56;Mood states using Mood and Feelings Questionnaire (MFQ)Timepoint: Day 0, 28 and 56;Quality of life using Digestive Associated Quality of Life Questionnaire <br/ ><br>(DQLQ)Timepoint: Day 0, 28 and 56;Satiety as assessed by the change in the Three-Factor Eating <br/ ><br>Questionnaire-R18 (TFEQ-R18)Timepoint: Day 0, 28 and 56;Stress as assessed by the change in the Perceived Stress ScaleTimepoint: Day 0, 28 and 56