The Effects of a Commercially Available Weight Loss Program on Body Weight in Overweight Men and Women

Exclusion Criteria

• •Females with prior diagnosis of premenstrual syndrome or Premenstrual dysphoric disorder (PMDD).
• •Subject has an abnormal laboratory test result of clinical significance at the Screening visit that upon re-testing has not normalized (per physician discretion).
• •Subject has had a weight loss or gain ≥10 lb (4.5 kg) in the three (3) months prior to Visit 1 (Week -1).
• •Subject has used weight loss medications within the past three months of Screening visit.
• •Subject has dietary tendencies that may be representative of disordered eating (in the opinion of the Investigator).
• •Subject has a known allergy, sensitivity, or intolerance to the study foods or any ingredients of the study menu provided.
• •Subject has previously been diagnosed diabetes mellitus (type 1 or type 2) or fasting glucose ≥126 mg/dL at the screening visit.
• •Subject is on thyroid medication at a dose that is not considered stable. Stable is same dose consistently for at least 90 days.
• •Subject has used any prescription weight loss medications within three months prior to Screening Visit, and any dietary supplements or programs intended to alter body weight within the last four weeks.
• •Subject uses hypoglycemic medications (with or without diagnosis of diabetes, e.g. metformin for PCOS is exclusionary) or dietary supplements that may affect carbohydrate metabolism.
• •Subject has used any prescription Corticosteroids (oral or systemic) within past three months.
• •Subjects using medications and dietary supplements likely to markedly affect appetite or metabolic rate (e.g., beta-blockers) may be excluded, based on the judgment of the Investigator (with washout prior to study randomization).
• •Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurologic disorders.
• •Subject has an active gastrointestinal disorder such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
• •Subject has an active infection or sign/symptoms of an infection. The randomization visit will be re-scheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days.
• •Subject has a history of gastrointestinal surgery that is known to affect nutrient absorption or body weight.
• •Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at the Screening visit.
• •Subject has a history or presence of cancer in the prior 5 years, except for non-melanoma skin cancer.
• •Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception (double-barrier method) throughout the study period. The method of contraception must be recorded in the source document.
• •Subject is a premenopausal female using a form of hormonal contraception that does not result in a normal menstrual cycle, including a regular menses period.
• •Subject has a recent history of (within 12 months of Visit 1, Week -1) or strong potential for alcohol or substance abuse. Alcohol abuse defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
• •Subject has been hospitalized within the past one-year for any mental or emotional illness.
• •Exposure to any non-registered drug product within 30 d prior to the screening visit.
• •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.