Clinical trial NCT05837754: A Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Health
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, placebo controlled, parallel group
Primary purpose: OTHER

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.


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:

  1. Waist circumference \> 102 cm (40 inches) for men and \> 88 cm (35 inches) for women;
  2. Fasting triglycerides \>150 mg/dL
  3. Blood pressure ≥130 mm Hg (Systolic Blood Pressure) and/or ≥85 mm Hg (Diastolic Blood Pressure);
  4. Fasting blood glucose ≥ 100 mg/ dl
  5. 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.
* No antibiotic usage within the last 30 days.
* History of stable weight over the last 6 months (\<10% change).
* Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.

Exclusion Criteria:

* 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:

  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\]
* 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.
* 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.
* 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
* 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.
* Exposure to any non-registered drug product within 3 months prior to the screening visit.
* Unable/unwillingness to complete study specific diaries (digital/paper-based).
* Current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/ dietary supplement.
* Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
* Heavy alcohol drinkers defined as follows:

For men, consuming more than 4 drinks on any day or more than 14 drinks/week For women, consuming more than 3 drinks on any day or more than 7 drinks/week

Primary outcomes:
measure: To assess efficacy of the Investigational Product (IP) on
timeFrame: Day 56
Secondary outcomes:
measure: To assess the effect of the of IP on Daily energy levels using Visual Analogue Scale - Fatigue
timeFrame: Day 0,1,2,3,4,5,28 and 56
measure: To assess the effect of the of IP on Fatigue Severity Scale (FSS)
timeFrame: Day 0, 28 and 56
measure: To assess the effect of the of IP on Immunomodulation using IFN-γ.
timeFrame: Day 0, 28 and 56
measure: To assess the effect of the of IP on Inflammation using TNF-α, IL-6 and IL-10
timeFrame: Day 0, 28 and 56
measure: To assess the effect of the of IP on Stress as assessed by the change in the Perceived Stress Scale.
timeFrame: Day 0, 28 and 56
measure: To assess the effect of the of IP on Quality of life using Digestive Associated Quality of Life Questionnaire (DQLQ).
timeFrame: Day 0, 28 and 56
measure: To assess the effect of the of IP on Satiety as assessed by the change in the Three-Factor Eating Questionnaire-R18 (TFEQ-R18).
timeFrame: Day 0, 28 and 56
measure: To assess the effect of the of IP on Mood states using Mood and Feelings Questionnaire (MFQ)
timeFrame: Day 0, 28 and 56
measure: 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).
timeFrame: Day 0 and 56
measure: To assess the effect of the of IP on Gut microbiome diversity using
timeFrame: Day 0 and 56
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Apex Hospital
state: Gujarat
city: Vadodara
country: India
facility: Aman Hospital and Research Centre
state: Gujarat
city: Mulund
country: India
facility: Hira Mongi Navneet Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Shantaee Nursing Home
state: Maharashtra
city: Pune
country: India
facility: Sangvi Multispeciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Lifepoint Multispeciality Hospital
state: Maharashtra
city: Jaipur
country: India
facility: Maharaja Agrasen Superspeciality Hospital
state: Rajasthan
Study officials:
References: