Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons

A randomized, non-blinded, controlled clinical trial using a parallel design of a hypocaloric, low fat (<30% energy from fat) diet with or without 2 oz of almonds over 18 months. Interim analyses will be conducted at 3, 6, 9 and 12 months. The study will be divided into 3 phases. Phase 1 (months 0-6) will be an active, intensive weight loss phase. During phase 1, all subjects will meet once a week in the evening for 1.5 hours. Phase 2 (months 6-12) will be a less intensive weight loss phase. During phase 2 groups will meet every other week in the evening for 1.5 hours. The last phase will be the weight maintenance phase or phase 3 (months 12-18).

Inclusion criteria

• Body mass index (BMI) > 27 but <40
• 18-75 years of age
• Men and non-pregnant or lactating women
• Subjects must be willing to comply with all study-related procedures

Exclusion criteria

• Uncontrolled hypertension
• Diabetes or use of anti-hyperglycemic medication
• Dyslipidemia requiring prescription drug therapy as defined by NCEP ATPIII guidelines at screening
• Known allergy or sensitivity to nuts
• Known atherosclerotic cardiovascular disease
• History of congestive heart failure
• History of a non-skin malignancy within the previous 5 years
• Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
• History of being HIV positive
• History of alcohol or drug abuse
• Weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
• Weight loss > 5 kg during the last 6 months
• Participation in an investigational drug study within 6 weeks prior to screening
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study