A Study to Assess the Efficacy of CaroRite™ on Psychological Well-being, Oxidative Stress and Quality of Life in Healthy Individuals

NCT05931315 | Completed

• 1 other identifier: BE/230401/CAR/LS
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

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.

Conditions

Psychological Well-Being; Oxidative Stress; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Oxidative stress as assessed by decrease in serum levels of 8-Isoprostanes.

  Day 90

• Immune Status as assessed by the increase in salivary IgA levels.

  Day 90

• Quality of life as assessed by increase in the scores of SF-36 questionnaire.

  Day 90

• Sleep quality as assessed by the decrease in the PSQI score

  Day 90

Study Arms (2)

CaroRite™

ACTIVE COMPARATOR

One capsule to be taken immediately post-dinner / with dinner

Dietary Supplement: CaroRite™

Placebo

PLACEBO COMPARATOR

One capsule to be taken immediately post-dinner / with dinner

Dietary Supplement: Placebo

Interventions

CaroRite™ DIETARY_SUPPLEMENT

One capsule to be taken immediately post-dinner / with dinner

CaroRite™

Placebo DIETARY_SUPPLEMENT

One capsule to be taken immediately post-dinner / with dinner

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (4)

Dr. Praphulla Awate's Clinic

Mumbai, Maharashtra, 400067, India

Location

The Kewalramani Clinic

Mumbai, Maharashtra, 400068, India

Location

Sangvi Hospital

Pune, Maharashtra, 411027, India

Location

Saikrupa Hospital

Pune, Maharashtra, 411033, India

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: August 22, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

IN (4)