Effect of a Novel Nutraceutical on Weight Loss and Weight Maintenance in Obese Subjects

Inclusion criteria

• BMI ≥ 30 and ≤ 47

Exclusion criteria

• Prohibited medications, supplements or herbal products

• Use of narcotics, oral or injectable corticosteroids, multivitamin/multimineral supplements, antioxidant supplements, vitamin D supplements, probiotics and omega-3 fatty acid supplements 30 days prior to screening and for the duration of the study.
• Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
• Change in prescription, OTC, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study.
• Medical history and concurrent diseases

• Known allergy or hypersensitivity to study product or placebo.
• Clinically significant abnormalities in medical history of physical examination.
• Clinically relevant conditions expected to preclude achievement of exercise recommendation.
• Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
• Diabetes mellitus, irritable bowel syndrome, Gastro-esophageal reflux disease, HIV, TB ,hepatitis B or C, malignancy, sleep apnea, insomnia (requiring use of sleeping medication more than once weekly), night eating syndrome, Anorexia nervosa, bulimia, of non-specific eating disorder, and serious psychiatric illness.
• Smoking or use of nicotine containing products within 30 days prior to screening and for the duration of the study.
• Use of drugs of abuse (e.g. marijuana, cocaine, PCP, and methamphetamine) within 30 days prior to screening and for the duration of the study.
• Other criteria

• Initiation of a new or change of an existing exercise regiment within 30 days prior to screening.
• Initiation of a new or change of an existing food plan within 30 days prior to screening.