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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT00194428
• Date of registration: 14/09/2005
• Primary sponsor: Temple University
• Public title: Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons
• Scientific title: Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons
• Date of first enrolment: February 2005
• Target sample size: 123
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00194428
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Gary D Foster, PhD
• Affiliation: Temple University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hyperlipidemia

Hypertension

Metabolic Syndrome X

Obesity

Intervention(s)

Behavioral: Almond enriched diet

Behavioral: Low fat caloric diet

Primary Outcome(s)

To evaluate the effects of an almond-enriched (2 oz/day) hypocaloric, low-fat diet on body weight and body composition in overweight and obese persons [Time Frame: 6 months]

Secondary Outcome(s)

To evaluate the effects of the almond enriched diet on established and emerging surrogate markers of coronoary artery disease (CAD) risk [Time Frame: 6 months]

Secondary ID(s)

802132

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Almond Board of California