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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 CaroRiteâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CaroRiteâ„¢ | Active Comparator | One capsule to be taken immediately post-dinner / with dinner |
|
| Placebo | Placebo Comparator | One capsule to be taken immediately post-dinner / with dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CaroRiteâ„¢ | Dietary Supplement | One capsule to be taken immediately post-dinner / with dinner |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress as assessed by decrease in serum levels of 8-Isoprostanes. | The normal reference range of 8-isoprostanes is 2-34 pg/ml | Day 90 |
| Immune Status as assessed by the increase in salivary IgA levels. |
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Praphulla Awate's Clinic | Mumbai | Maharashtra | 400067 | India | ||
| The Kewalramani Clinic |
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Randomized, double-blind, placebo-controlled trial
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Triple
| Placebo |
| Dietary Supplement |
One capsule to be taken immediately post-dinner / with dinner |
|
The normal reference range of IgA levels are: male 28.0 - 188.2 ng/ml; female 32.4 - 156.8 ng/ml.
| 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) | 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 | Day 90 |
| Mumbai |
| Maharashtra |
| 400068 |
| India |
| Sangvi Hospital | Pune | Maharashtra | 411027 | India |
| Saikrupa Hospital | Pune | Maharashtra | 411033 | India |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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