Gut HealthNCT05837754
A Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults
A study testing C8-C12 in people with Gut Health, run by Vedic Lifesciences Pvt. Ltd. at 7 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Health
- What is being tested?
- C8-C12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 7 sitesIndia
- Study dates
- 4 Apr 2023to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Apex Hospital
Ahmedabad, Gujarat, 380013
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, 302039
Hira Mongi Navneet Hospital
Mulund East, Maharashtra, 400080
Shantaee Nursing Home
Mumbai, Maharashtra, 400067
Sangvi Multispeciality Hospital
Pune, Maharashtra, 411027
Lifepoint Multispeciality Hospital
Pune, Maharashtra, 411057
Aman Hospital and Research Centre
Vadodara, Gujarat, 390021
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults
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
- Being tested
- C8-C12, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C8-C12Other
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess efficacy of the Investigational Product (IP) on
Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein at day 56 from baseline.
Measured: Day 56
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 0 and 56
To assess the effect of the of IP on Gut microbiome diversity using
16s RNA sequencing
Measured: Day 0 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start4 Apr 2023
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, placebo controlled, parallel group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837754
- Sponsor's protocol ID
- JR/220801/OC/GH
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults
- ClinicalTrials.gov ID
- NCT05837754
- Acronym / sponsor ID
- JR/220801/OC/GH
- Conditions
- Gut Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled, parallel group
| Arm | Type | Receives |
|---|---|---|
| C8-C12 | Active comparator | Other: C8-C125-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP |
| Placebo | Placebo comparator | Other: Placebo5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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:
- SGOT, SGPT ≤ 2 times the upper normal limit.
- Creatinine levels ≤ 1.5 times the upper normal limit.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C8-C125-15mL (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 |
| Placebo5-15mL (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 |
Primary outcome
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.
10 secondary outcomes
To assess the effect of the of IP on Daily energy levels using Visual Analogue Scale - 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)
Time frame: Day 0, 28 and 56
To assess the effect of the of IP on Immunomodulation using IFN-γ.
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
Time frame: 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.
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).
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).
Time frame: Day 0, 28 and 56
To assess the effect of the of IP on Mood states using Mood and Feelings Questionnaire (MFQ)
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).
Time frame: Day 0 and 56
To assess the effect of the of IP on Gut microbiome diversity using
Time frame: Day 0 and 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C8-C12 in people with Gut Health, run by Vedic Lifesciences Pvt. Ltd. at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess efficacy of the Investigational Product (IP) on (time frame: Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.