A Prospective Study Investigating the Effects of a Novel Weight Management Program

Exclusion Criteria

• •1. A subject that has any Axis I Psychiatric disorders according to the DSM-IV criteria that would prevent the subject from being able to comply with study requirements and/or taking anti-psychotic medication
• •2. Diagnosed with insomnia and is chronically using prescribed or OTC insomnia medications
• •3. A self-reported chronic condition that may affect subject safety
• •4. An HbA1c of greater than or equal to 7.0%
• •5. Renal insufficiency as defined by a laboratory Glomerular Filtration Rate of less than 50 mL/min/1.73 m2
• •6. Chronically using glucocorticoid steroids
• •7. Currently pregnant, planning to become pregnant during the course of the study or is breastfeeding
• •8. Use of antihypertensive medication(s) for less than 90 days prior to screening
• •9. Diagnosed with any thyroid disorder or has a clinically significant out of range laboratory value (i.e. TSH, T3 Free, and/or T4 Free) value measured at screening
• •10. Known allergy or intolerance to any of the ingredients contained in the Novel Supplements, placebos or shakes (cow milk proteins)
• •11. Planned surgical procedure during the 365 day course of the study
• •12. Currently participating in another clinical research study or have done so within 30 days prior to the screening visit
• •13. Diagnosis of milk or egg intolerance
• •14. Participating in another weight loss program or using another weight loss product. Subjects may enroll if they are willing to stop the weight loss program they are currently on and/or washout of the product they are using. The appropriate washout will be reviewed with the investigator or medically qualified designee on a case by case basis
• •15. Fasting LDL-C greater than 190 mg/dL or triglycerides greater than 400 mg/dL.
• •16. Unwilling to discontinue consumption of green or black tea or green or black tea extracts beginning at the screening visit and after signing of the informed consent
• •17. Unwilling to discontinue use of over-the-counter and/or prescribed vitamin supplements except for: multivitamins, calcium, fish oil, vitamin C, vitamin D, vitamin E, zinc or iron
• •18. Plans to have plastic or reconstructive surgery or any other procedure that, in the opinion of the investigator, could influence body composition, at any time during the year long study
• •19. Unable to lay supine for at least 30 minutes
• •20. Cognitive impairment that would limit ability to understand or follow diet instructions and/or comply with the study protocol