The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout/withdrawal rate of 25%. The intervention duration for all the study participants is 180 days.
Male & female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Individual has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18.5 to 29.9 kg/m2 (inclusive)
Individuals with a stressed lifestyle as assessed by PSS scores within 27- 40.
Individual has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinology related, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention, or interfering with the interpretation of data.
Males who has a history of oligospermia, vasectomy and other sperm abnormalities.
Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome.
Individuals with Type 1 and Type 2 Diabetes mellitus and on medication.
Parallel
CBD Isolate (25 mg/0.5 ml)
Dietary supplement0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (40 mg/0.5 ml)
Dietary supplement0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (50 mg/0.5 ml)
Dietary supplement0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Broad Extract (50 mg/0.5 ml)
Dietary supplement0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Placebo
Dietary supplement0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Fasting Glucose normal range is 74 - 106 mg/dL
To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Fasting Glucose normal range is 74 - 106 mg/dL
To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Fasting Glucose normal range is 74 - 106 mg/dL
To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Glomerular Filtration Rate (GFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL GFR: Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL
To assess the safety and tolerability of VL-SE-01 using blood, which includes Complete Blood Count (CBC).
CBC measures red blood cells (RBC) which basically carries oxygen, white blood cells (WBC)(Leukocytes), which fights with infection, hemoglobin (Hb), which carries oxygen protein in blood cells, and platelets, which help blood to clot. A complete blood count can show unusual increases or decreases in cell counts. Normal ranges for the parameters are as follows: Hb: Males: 13 - 17 g/dL; Females - 11.5 - 15.2 g/dL Total RBC: Males - 4.2 - 6.0 million cells/cumm; Females - 3.8 - 5.2 million cells/cumm Total WBC: 3500 - 10000 / cumm Platelet Count: 150000 - 400000 / cumm
To assess the safety and tolerability of VL-SE-01 using blood, which includes Inflammation by analyzing CRP levels.
Normal reference range: 0 -5.0 mg/L
To assess the safety and tolerability of VL-SE-01 using blood, which includes Hormonal profile (Luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone, estradiol and progesterone)
Leutinizing Hormone in Females reference range: Follicular Phase : 2.4 - 12.6 mIU/mL Ovulating Phase : 14.0 - 95.6 mIU/mL Luteal Phase : 1.0 - 11.4 mIU/mL Post menopausal : 7.7 - 58.5 mIU/mL Follicular Stimulating Hormones in Females reference range: Follicular Phase : 3.5 - 12.5 mIU/mL Ovulating Phase : 4.7 - 21.5 mIU/mL Luteal Phase : 1.7 - 7.7 mIU/mL Post menopausal : 25.8 - 134.8 mIU/mL Progesterone in Females reference ranges: Follicular phase: 0.2 - 1.5 ng/ml Ovulatory phase: 0.8 - 3.0 ng/ml Luteal phase: 1.7 - 27.0 ng/ml Post menopause: 0.1 - 0.8 ng/ml Estradiol in females reference range: Follicular phase :12.5-166 pg/ml Ovulatory phase :85.5-498 pg/ml Luteal phase : 43.8-211 pg/ml Post menopause : 5.0-54.7 pg/ml Pregnancy,1st trimester: 215-4300 pg/ml Testosterone in Males reference range: 2.8 - 8.0 ng/mL
To assess the safety and tolerability of VL-SE-01 using blood, which includes Thyroid profile (T3, T4, TSH)
Total Triiodothyronine (T3) reference range: 1.3 - 3.1 nmol/L Total Thyroxine (T4) reference range: 5.1 - 14.1 μg/dL Thyroid Stimulating Hormone (TSH) reference range: 0.27 - 4.2 μIU/mL
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