Status:
COMPLETED
Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons
Lead Sponsor:
Temple University
Collaborating Sponsors:
Almond Board of California
Conditions:
Obesity
Metabolic Syndrome X
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 cardiov...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00194428
Start Date
February 1 2005
End Date
October 1 2009
Last Update
March 28 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Temple University
Philadelphia, Pennsylvania, United States, 19140