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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.
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).
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
Yes
Temple University
Philadelphia, Pennsylvania, United States
Start Date
February 1, 2005
Primary Completion Date
October 1, 2007
Completion Date
October 1, 2009
Last Updated
March 28, 2013
123
ACTUAL participants
Almond enriched diet
BEHAVIORAL
Low fat caloric diet
BEHAVIORAL
Lead Sponsor
Temple University
Collaborators
NCT01143454
NCT07472881
Data Source & Attribution
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