NCT00194428

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to study the safety, tolerability and efficacy of an almond enriched hypocaloric diet on weight loss and weight maintenance, as well as on established and emerging cardiovascular risk factors in approximately 112 overweight and obese persons.

Detailed description

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).

Conditions

• Obesity
• Metabolic Syndrome X
• Hyperlipidemia
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Almond enriched diet	Subjects will consume 2 oz. of almond per day in addition to a low-fat diet
BEHAVIORAL	Low fat caloric diet	Low fat caloric diet

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-10-01
• Completion: 2009-10-01
• First posted: 2005-09-19
• Last updated: 2013-03-28

Locations

1 site across 1 country: United States