Clinical trial NCT05931315: A Study to Assess the Efficacy of CaroRite™ on Psychological Well-being, Oxidative Stress and Quality of Life in Healthy Individuals
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Well-Being
Oxidative Stress
Quality of Life
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 78
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 trial
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: 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:

  1. Waist circumference \> 101.6 cm (40 inches) for men and \> 88.9 cm (35 inches) for women;
  2. Triglycerides \> 150 mg/dL;
  3. Blood pressure ≥ 130 mm Hg (Systolic Blood Pressure) and/or ≥ 80 mm Hg (Diastolic Blood Pressure);
  4. Fasting blood glucose ≥ 100 mg/dL;
  5. 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: To assess the impact of the Investigational Product (IP) on psychological well-being using the Psychological General Well-Being Index (PGWBI).
timeFrame: Day 90
Secondary outcomes:
measure: Oxidative stress as assessed by decrease in serum levels of 8-Isoprostanes.
timeFrame: Day 90
measure: Immune Status as assessed by the increase in salivary IgA levels.
timeFrame: Day 90
measure: Quality of life as assessed by increase in the scores of SF-36 questionnaire.
timeFrame: Day 90
measure: Sleep quality as assessed by the decrease in the PSQI score
timeFrame: Day 90
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Dr. Praphulla Awate's Clinic
state: Maharashtra
city: Mumbai
country: India
facility: The Kewalramani Clinic
state: Maharashtra
city: Pune
country: India
facility: Sangvi Hospital
state: Maharashtra
city: Pune
country: India
facility: Saikrupa Hospital
state: Maharashtra
Study officials:
References: