Randomized Double-Blind Study to Evaluate Safety, Effects, and Doses of VL-SE-01 in Healthy Adults Ages 18 to 55

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics, and efficacy of different doses of VL-SE-01, a dietary supplement containing CBD, in healthy adults aged 18 to 55 years. This randomized, placebo-controlled, parallel study plans to enroll approximately 200 participants who will be assigned to one of five groups, including various doses of CBD isolate and broad extract or placebo. The study aims to understand how VL-SE-01 affects fasting blood glucose, liver and kidney function, and other health markers over time. Participants will receive a 0.5 ml dose of their assigned study product sublingually after dinner, about 30 minutes before bedtime, daily for 180 days. The study includes five groups with different CBD doses or placebo, each expected to include at least 30 participants completing the treatment. The intervention duration is the same for all groups, and the study uses a triple-blind design to ensure unbiased results. Throughout the study, participants will undergo a series of assessments, including blood tests to monitor metabolic panels, renal and liver function, hormone and thyroid profiles, lipid levels, inflammation markers, and CBD plasma levels. They will also complete questionnaires on gastrointestinal symptoms, sleep quality, insomnia, fatigue, stress, and menstrual cycle regularity at specified intervals. Safety evaluations include monitoring blood pressure, pulse rate, electrocardiograms, semen analysis for males, and adverse events, with follow-up visits extending shortly after the 180-day treatment period.

A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.