Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are studying the effects of daily Jarlsberg cheese intake combined with calcium and vitamin D on bone health in people at risk for osteoporosis. The study focuses on osteopenia patients, defined as post-menopausal women and men over 55 years old with specific bone density scores between 0.0 and -2.5. This randomized, single-blinded trial aims to compare changes in Bone Mineral Density BMD and various bone markers between those receiving calcium and vitamin D alone and those receiving these plus Jarlsberg cheese. Participants receive daily calcium 1000 mg and vitamin D 20g tablets, with one group also having an optimal efficacy dose of Jarlsberg cheese 45 g for women, 55 g for men. After an initial screening week without Jarlsberg cheese, study patients are randomized to either calcium and vitamin D alone or with Jarlsberg for 16 weeks. Following this, all participants receive calcium, vitamin D, and Jarlsberg cheese for a further 16 weeks. This means the total study duration is 32 weeks for those initially on Jarlsberg and 48 weeks for those starting on calcium and vitamin D only. During the trial, participants will have bone density scans and blood tests at baseline and every 16 weeks, measuring bone markers, osteocalcin, and other biochemical variables. They will use a diet app to record food intake and keep daily logs of their treatment and physical activity. Safety and adverse events are monitored throughout. After completing the trial, participants may continue Jarlsberg intake and are followed up one year later with further assessments.
Actively Recruiting
Researchers are evaluating the recommended oral dose of BP-C2 alongside hormone treatment in patients with prostate cancer. This Phase 1, open-label, multi-center study uses a Response Surface Pathway design to find the optimal dose for patients aged 18 to 80 years undergoing hormonal therapy. The trial aims to assess tolerability and toxicity using standardized criteria and quality of life measures. Treatment involves daily oral doses of BP-C2, starting at 1.0 mgkg body weight for four weeks, with dose adjustments every four weeks based on individual tolerability. Patients receive three successive four-week treatment levels where doses may be increased or decreased depending on adverse event severity. The trial includes close monitoring and dose changes guided by toxicity scores to optimize safety and dose recommendations. Participants undergo a seven-day screening with clinical exams and blood tests before starting treatment. Throughout the study and follow-up, researchers will measure adverse events using the CTCAE scale, quality of life with EQ-5D-5L questionnaires, and prostate-specific antigen levels. Safety, tolerability, and quality of life are assessed at regular intervals during treatment and at the four-week post-treatment follow-up, with total participation lasting approximately 15 weeks.