The present study is a randomized, placebo-controlled, feasibility study to evaluate efficacy of dietary ingredients in vitality \& metabolic factors in healthy individuals. Approximately 54 subjects aged between ≥ 40 and ≤ 60 years will be screened and 36 participants (12 in each arm) are to be randomized. Both the IP and placebo study arms will have 10 completed subjects in each arm after accounting for the screening failure and dropout/withdrawal rate of 30% and 17% respectively (Total 30 completers). The treatment duration for all the study subjects will be 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
35
1 capsule twice a day (Before breakfast \& dinner)
1 capsule twice a day (Before breakfast \& dinner)
1 capsule twice a day (Before breakfast \& dinner)
Dr. Khare's Clinic
Mumbai, Maharashtra, India
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, India
To assess the efficacy of the Investigational Product (IP) on Glucose Metabolism as assessed by change in serum fasting glucose levels.
The normal values for normal fasting blood glucose concentration are between 4.11-6.05 mmol/L (74-109 mg/dL).
Time frame: Day 0
To assess the efficacy of the Investigational Product (IP) on Glucose Metabolism as assessed by change in serum fasting glucose levels.
The normal values for normal fasting blood glucose concentration are between 4.11-6.05 mmol/L (74-109 mg/dL).
Time frame: Day 90
To assess the efficacy of the Investigational Product (IP) on Fat metabolism as assessed by serum lipid profile.
Desirable cholesterol level: \< 5.17 mmol/L (\< 200 mg/dL); Triglycerides: \< 1.70 mmol/L (\< 150 mg/dL); HDL Cholesterol - Males: 45 - 65 mg/dL, Females: 35 - 55 mg/dL
Time frame: Day 0 and Day 90
To assess the efficacy of the Investigational Product (IP) on future assessment of vitality related biomarkers
Blood sample will be collected for post hoc analysis
Time frame: Day 0, Day 30 and Day 90
To assess the efficacy of the Investigational Product (IP) on perceived immune system as assessed by Immune System Questionnaire (ISQ)
The ISQ has seven questions. The sum score is calculated. Interpretation: 0 = very poor and 10= excellent perceived immune status.
Time frame: Day 0, Day 30, Day 60 and Day 90
To assess the efficacy of the Investigational Product on Physical energy as assessed by energy VAS
The VAS consists of a 10cm line, with two end points representing 0 ('no energy') and 10 ('most energetic')
Time frame: Day 0, Day 14, Day 30, Day 60 and Day 90
To assess the efficacy of the Investigational Product on Fatigue level as assessed by Fatigue Severity Scale (FSS)
The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 indicates strong agreement, and the final score represents the mean value of the 9 items.
Time frame: Day 0, Day 14, Day 30, Day 60 and Day 90
To assess the efficacy of the Investigational Product on Sleep as assessed by Pittsburg Sleep Quality Index
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). Higher scores indicate worse sleep quality.
Time frame: Day 0, Day 14, Day 30, Day 60 and Day 90
To assess the efficacy of the Investigational product on Stress perception as assessed by the Cohen Perceived Stress score
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
Time frame: Day 0, Day 14, Day 30, Day 60 and Day 90
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