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

Completed · Phase 1/Phase 2

Conditions studied: Obesity, Metabolic Syndrome X, Hyperlipidemia, Hypertension

In brief

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.

Key facts

Study ID

NCT00194428

Run by

Temple University

People needed

123

Starts

2005-02-01

Expected to finish

2009-10-01

Last updated by the study team

2013-03-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Temple University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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