A Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults

NCT05837754 | Completed

• 1 other identifier: JR/220801/OC/GH
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 7

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.

Conditions

Gut Health

Outcome Measures

Primary Outcomes (1)

• To assess efficacy of the Investigational Product (IP) on

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

  Day 56

Secondary Outcomes (10)

• 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 Inflammation using TNF-α, IL-6 and IL-10

  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

Study Arms (2)

C8-C12

ACTIVE COMPARATOR

5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP

Other: C8-C12

Placebo

PLACEBO COMPARATOR

5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP

Other: Placebo

Interventions

C8-C12 OTHER

5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP.

C8-C12

Placebo OTHER

5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.
• No self-reported physical/mental disabilities or gastrointestinal conditions.

You may not qualify if:

• Pure vegetarians who do not consume chicken, fish and/or egg.
• Smokers
• 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. \[Diagnostic criteria\* Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
• Related to defecation.
• Associated with a change in frequency of stool.
• Associated with a change in form (appearance) of stool. \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis\]
• Use of any psychotropic medication within four weeks of screening and throughout the study.
• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (7)

Apex Hospital

Ahmedabad, Gujarat, 380013, India

Location

Aman Hospital and Research Centre

Vadodara, Gujarat, 390021, India

Location

Hira Mongi Navneet Hospital

Mulund East, Maharashtra, 400080, India

Location

Shantaee Nursing Home

Mumbai, Maharashtra, 400067, India

Location

Sangvi Multispeciality Hospital

Pune, Maharashtra, 411027, India

Location

Lifepoint Multispeciality Hospital

Pune, Maharashtra, 411057, India

Location

Maharaja Agrasen Superspeciality Hospital

Jaipur, Rajasthan, 302039, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Stratified block randomization, Sequentially numbered, sealed, opaque envelopes
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled, parallel group

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 1, 2023
• Study Start: April 4, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (7)