None listed
Conditions
Interventions
Intervention1: CaroRiteTM: One capsule a day to be taken immediately post-dinner 0r with dinner for 90 days
Control Intervention1: Placebo: One capsule a day to be taken immediately post-dinner 0r wit
Sponsors
Vedic Lifesciences Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female individuals aged not less than equal to 18 and more than equal to 60 years with low to moderate physical activity level as per International Physical Activity Questionnaire – Short Form (IPAQ - SF) 2. BMI of not less than equal to 25 to not more than 29.9 kg/m2 3. Having at least two of the following five metabolic risk factors: i. Waist circumference not more than equal to 101.6 cm (40 inches) for men and not more than equal to 88.9 cm (35 inches) for women; ii. Triglycerides > 150 mg/dL; iii. Blood pressure not more than equal to 130 mm Hg (Systolic Blood Pressure) and/or not more than equal to 80 mm Hg (Diastolic Blood Pressure); iv. Fasting blood glucose not more than 100 mg/dL v. low HDL cholesterol level (less than 40 mg/dL in men and less than 50 mg/dL in women) 4. Individuals with PGWBI scores of moderate distress (between 61 and 72) 5. Individuals with history of physical and/or mental exhaustion since last 4 weeks. 6. Willing to complete all study procedures including study-related questionnaires and comply with study requirements 7. Willing to abstain from other supplements or medication 8. Ready to give voluntary, written, informed consent to participate in the study 9. No self-reported physical/mental disabilities or gastrointestinal conditions 10. History of stable weight over the last 6 months (less than 10% change). 11. Not currently pregnant, planning to become pregnant, or currently breastfeeding. 12. Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol
Exclusion criteria
Exclusion criteria: 1. Smokers. 2. Presence of unstable, acutely symptomatic, or life-limiting illness. 3. Individuals with uncontrolled hypertension with systolic blood pressure more than equal to 140 mm Hg and/or diastolic blood pressure more than equal to 90 mm Hg. 4. Individuals with diagnosed Type II Diabetes Mellitus with FBG more than equal to 126 mg/dL. 5. Neurological conditions causing functional or cognitive impairments. 6. Unwillingness or inability to be randomized to one of the two intervention groups. 7. Hypo or hyper thyroidism as assessed by TSH (Thyroid Stimulating Hormone) levels less than 0.4 µIU/L and more tham 4.50 µIU/L. 8. Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks per week. For women, consuming more than 3 drinks on any day or more than 7 drinks per week. 9. 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 participants 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. 10. Use of any psychotropic medication within four weeks of screening and throughout the study 11. 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 12. 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 13. 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. 14. Exposure to any non-registered drug product within 3 months prior to the screening visit. 15. Unable/unwillingness to complete study specific diaries (digital/paper-based). 16. Current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/ dietary supplement. 17. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 18. Individuals with any reported allergy or intolerance to any ingredient in the study products. 19. Individuals deemed unsuitable for study based upon study physician assessment. 20. Individuals who have been a part of another clinical trial in the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the impact of the investigational product (IP) on psychological well-being using the Psychological General Well-Being Index (PGWBI).Timepoint: Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of IP on Immune Status as assessed by the increase in salivary IgA levels.Timepoint: Day 90;To assess the effect of IP on Oxidative stress as assessed by decrease in serum levels of 8-IsoprostanesTimepoint: Day 90;To assess the effect of IP on Sleep quality as assessed by the decrease in the PSQI score.Timepoint: Day 90;To assess the impact of the IP on Quality of life using 36 Item Short Form Health Survey (SF-36)Timepoint: Day 90 | — |
Countries
India
Contacts
Public ContactDr Rohit Singh
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed