Psychological Well-BeingNCT05931315
A Study to Assess the Efficacy of CaroRite™ on Psychological Well-being, Oxidative Stress and Quality of Life in Healthy Individuals
A study testing CaroRite™ in people with Psychological Well-Being and Oxidative Stress, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.
Trial summary
The present study is a randomized, placebo-controlled, double-blind clinical study in which 94 individuals will be screened, and considering a screening failure rate of 20%, approximately 76 participants will be randomized in a ratio of 1:1 to receive either CaroRite™ or placebo and will be assigned a unique… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-Being, Oxidative Stress, Quality of Life
- What is being tested?
- CaroRite™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 4 sitesIndia
- Study dates
- 22 Aug 2023to 15 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 individuals aged ≥18 and ≤60 years with low to moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF).
- BMI of ≥ 25 to ≤ 29.9 kg/m2
- Having at least two of the following five metabolic risk factors:
- Waist circumference > 101.6 cm (40 inches) for men and > 88.9 cm (35 inches) for women;
- Triglycerides > 150 mg/dL;
- Blood pressure ≥ 130 mm Hg (Systolic Blood Pressure) and/or ≥ 80 mm Hg (Diastolic Blood Pressure);
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- Fasting blood glucose ≥ 100 mg/dL;
- low HDL cholesterol level (less than <40 mg/ dL in men and <50 mg/dL in women)
- Individuals with PGWBI scores of moderate distress (between 61 and 72).
- Individuals with history of physical and/or mental exhaustion since last 4 weeks.
- 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.
- No self-reported physical/mental disabilities or gastrointestinal conditions.
- History of stable weight over the last 6 months (<10% change).
- Not currently pregnant, planning to become pregnant, or currently breastfeeding.
- Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
Who cannot join
- Smokers.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Individuals with uncontrolled hypertension with systolic blood pressure ≥ 140 mm Hg and diastolic blood pressure ≥ 90 mm Hg.
- Individuals with diagnosed 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 the two intervention groups.
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- Hypo- or hyper- thyroidism as assessed by TSH (Thyroid Stimulating Hormone) levels < 0.4 μIU/L and > 4.50 μIU/L.
- 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.
- 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 individual at undue risk.
- 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 allow the individuals to wash off the antibiotic for at least five days prior to any test visit.
- Use of any supplements (may include probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, vitamins with probiotics) within two weeks of screening and throughout the study.
- Individuals that 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.
- Individuals with any reported allergy or intolerance to any ingredient in the study products.
- Individuals deemed unsuitable for study based upon study physician assessment.
- Individuals who have been a part of another clinical trial in the past year.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Dr. Praphulla Awate's Clinic
Mumbai, Maharashtra, 400067
The Kewalramani Clinic
Mumbai, Maharashtra, 400068
Sangvi Hospital
Pune, Maharashtra, 411027
Saikrupa Hospital
Pune, Maharashtra, 411033
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy of CaroRite™ on Psychological Well-being, Oxidative Stress and Quality of Life in Healthy Individuals
The present study is a randomized, placebo-controlled, double-blind clinical study in which 94 individuals will be screened, and considering a screening failure rate of 20%, approximately 76 participants will be randomized in a ratio of 1:1 to receive either CaroRite™ or placebo and will be assigned a unique randomization code. Each group will have at least 30 completed participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 90 days.
- Conditions
- Psychological Well-Being, Oxidative Stress, Quality of Life
- Being tested
- CaroRite™, Placebo
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaroRite™Dietary supplement
One capsule to be taken immediately post-dinner / with dinner
PlaceboDietary supplement
One capsule to be taken immediately post-dinner / with dinner
| Study group | Role | What they receive |
|---|---|---|
| CaroRite™ | Active comparator | One capsule to be taken immediately post-dinner / with dinner Receives: Dietary Supplement: CaroRite™ |
| Placebo | Placebo comparator | One capsule to be taken immediately post-dinner / with dinner Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of the Investigational Product (IP) on psychological well-being using the Psychological General Well-Being Index (PGWBI).
The PGWBI comprises of six sub-scales assessing the positive and negative states on a six-point Likert scale (0 = absence of psychological well-being; to 5 = high levels of well-being). Scores between 0 and 60 indicate severe distress, between 61 and 72 reflect moderate distress, and between 73 and 110 indicate a positive psychological well-being.
Measured: Day 90
Secondary outcomes (4)
Oxidative stress as assessed by decrease in serum levels of 8-Isoprostanes.
The normal reference range of 8-isoprostanes is 2-34 pg/ml
Measured: Day 90
Immune Status as assessed by the increase in salivary IgA levels.
The normal reference range of IgA levels are: male 28.0 - 188.2 ng/ml; female 32.4 - 156.8 ng/ml.
Measured: Day 90
Quality of life as assessed by increase in the scores of SF-36 questionnaire.
The SF-36 includes multi-item scales to measure the following 8 dimensions (refer 15.2 for questionnaire):
PF- Physical functioning (10 items in question 3) RP- Role limitations due to physical health problems (4 items in question 4) BP- Overall body pain (questions 7 and 8) SF- Social functioning (questions 6 and 10) MH - General mental health, covering psychological distress and well-being (5 items: questions 9 b, c, d, f and h) RE- Role limitations due to emotional problems (questions 5 a, b and c) VT- Vitality, energy or fatigue (4 items: questions 9 a, e, g and i) GH- General health perceptions (5 items: questions 1 and 11 a to d)
Measured: Day 90
Sleep quality as assessed by the decrease in the PSQI score
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). All the seven component scores are to be added together for calculating the Global PSQI Score. Higher scores indicate worse sleep quality
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start22 Aug 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-BeingStudies 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 trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 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
- NCT05931315
- Sponsor's protocol ID
- BE/230401/CAR/LS
- Status last verified
- Apr 2024
- First submitted
- 26 Jun 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Study to Assess the Efficacy of CaroRite™ on Psychological Well-being, Oxidative Stress and Quality of Life in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05931315
- Acronym / sponsor ID
- BE/230401/CAR/LS
- Conditions
- Psychological Well-Being, Oxidative Stress, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 5 Jul 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 clinical study in which 94 individuals will be screened, and considering a screening failure rate of 20%, approximately 76 participants will be randomized in a ratio of 1:1 to receive either CaroRite™ or placebo and will be assigned a unique randomization code. Each group will have at least 30 completed participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 90 days.
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 trial
| Arm | Type | Receives |
|---|---|---|
| CaroRite™ | Active comparator | Dietary Supplement: CaroRite™One capsule to be taken immediately post-dinner / with dinner |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne capsule to be taken immediately post-dinner / with dinner |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male and female individuals aged ≥18 and ≤60 years with low to moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF).
- BMI of ≥ 25 to ≤ 29.9 kg/m2
- Having at least two of the following five metabolic risk factors:
- Individuals with PGWBI scores of moderate distress (between 61 and 72).
- Individuals with history of physical and/or mental exhaustion since last 4 weeks.
Key exclusion criteria (20 listed)
- Smokers.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Individuals with uncontrolled hypertension with systolic blood pressure ≥ 140 mm Hg and diastolic blood pressure ≥ 90 mm Hg.
- Individuals with diagnosed Type II Diabetes Mellitus with FBG ≥ 126 mg/ dL.
- Neurological conditions causing functional or cognitive impairments.
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 |
|---|---|---|
| CaroRite™One capsule to be taken immediately post-dinner / with dinner | Dietary supplement | CaroRite™ |
| PlaceboOne capsule to be taken immediately post-dinner / with dinner | Dietary supplement | Placebo |
Primary outcome
To assess the impact of the Investigational Product (IP) on psychological well-being using the Psychological General Well-Being Index (PGWBI).
Time frame: Day 90
The PGWBI comprises of six sub-scales assessing the positive and negative states on a six-point Likert scale (0 = absence of psychological well-being; to 5 = high levels of well-being). Scores between 0 and 60 indicate severe distress, between 61 and 72 reflect moderate distress, and between 73 and 110 indicate a positive psychological well-being.
4 secondary outcomes
Oxidative stress as assessed by decrease in serum levels of 8-Isoprostanes.
Time frame: Day 90
Immune Status as assessed by the increase in salivary IgA levels.
Time frame: Day 90
Quality of life as assessed by increase in the scores of SF-36 questionnaire.
Time frame: Day 90
Sleep quality as assessed by the decrease in the PSQI score
Time frame: Day 90
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: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaroRite™ in people with Psychological Well-Being and Oxidative Stress, run by Vedic Lifesciences Pvt. Ltd. at 4 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 17 inclusion and 20 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 4 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 the impact of the Investigational Product (IP) on psychological well-being using the Psychological General Well-Being Index (PGWBI). (time frame: Day 90). 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.