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CLINICAL TRIALS PROFILE FOR EPICATECHIN

Clinical Trials for Epicatechin

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00200759	Drug Interactions and Bioavailability of Cranberry	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 1	The purpose of this study is to evaluate the potential of cranberry juice to interact with conventional drugs. This study will also determine the the amount of cranberry flavonoids that appear in the blood and in the urine.
NCT00200759	Drug Interactions and Bioavailability of Cranberry	Completed	Office of Dietary Supplements (ODS)	Phase 1	The purpose of this study is to evaluate the potential of cranberry juice to interact with conventional drugs. This study will also determine the the amount of cranberry flavonoids that appear in the blood and in the urine.
NCT00200759	Drug Interactions and Bioavailability of Cranberry	Completed	Medical University of South Carolina	Phase 1	The purpose of this study is to evaluate the potential of cranberry juice to interact with conventional drugs. This study will also determine the the amount of cranberry flavonoids that appear in the blood and in the urine.
NCT00434499	Effect of EGCG on the Body's Response to Insulin	Withdrawn	University of Maryland	Phase 2	This study will examine whether epigallocatechin gallate (EGCG), a major component of green tea, affects how the body responds to insulin in healthy and obese people. Insulin is not as effective in people who are overweight, have high blood pressure or diabetes. This condition is known as insulin resistance. Laboratory studies suggest that green tea or EGCG treatment lowers blood pressure, lowers blood sugar and increases blood flow. This study will see if EGCG improves insulin resistance or insulin's effects on blood flow in people with insulin resistance. Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for this study. Participants are randomly assigned to take EGCG or a placebo ( inactive dummy pill ) in two 4-week treatment phases with a 2-week period of no study medication before each treatment phase. After the first 4-week treatment, patients on placebo are switched to EGCG and those on EGCG are switched to placebo. In addition to treatment, participants undergo the following procedures during the study period: - Screening, including medical history, physical examination and blood and urine tests, and finger-stick blood sugar measurement for patients with diabetes - Complete a dietary and physical activity questionnaire and consult with a dietitian - Blood and urine tests - At-home and clinic blood pressure monitoring - Glucose clamp test to measure how the body responds to insulin. This test is done three times during the study. A needle is placed in a vein in each of the subject's arms, one for sampling blood and the other for infusing insulin, glucose and potassium. Glucose and insulin levels, electrolytes, lipids, fatty acids, cytokines and epicatechin are measured. - Forearm blood flow measurement with microbubbles and ultrasound. Before beginning the glucose clamp test, a test of how well the blood vessels relax is done. A device that measures the size of the artery in the upper arm is placed above the elbow. Blood flow in the muscle of the forearm is measured by ultrasound using a small infusion through a vein of microbubble contrast agent consisting of gas-filled bubbles the size of red blood cells. The contrast agent is infused over a 7- to 9-minute period at the beginning of the glucose clamp test and again 2 hours after the beginning of the test.
NCT00666562	Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given before surgery in treating patients with bladder. This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo when given before surgery in treating patients with nonmetastatic bladder cancer.
NCT01856868	Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)	Unknown status	Cardero Therapeutics, Inc.	Phase 1/Phase 2	(-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired skeletal muscle function in Becker Muscular Dystrophy (BMD) patients. This is a proof-of-concept phase 1/2a pilot and endpoint development study that is designed to provide initial evidence of biological activity of (-)-epicatechin. Primary endpoints include initial assessment of tissue-specific evidence of efficacy from muscle biopsy samples. Secondary endpoints include measures of strength and physical function, and safety and adverse event data. Pilot endpoints include assessment of mRNA and miRNA peripheral blood profiles and validation of non-invasive near-infrared spectroscopy (NIRS) muscle perfusion studies during exercise and a recumbent cycle exercise test that may be employed as endpoints in future clinical trials. This single center open-label pilot study will enroll 10 adults with genetically-confirmed Becker muscular dystrophy, who will receive the purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be enrolled in the study if they meet all inclusion criteria. They will be evaluated at baseline and at screening, day 1, and weeks 1, 2, 4 and 8.
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