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

This study has been completed.
Almond Board of California
Information provided by (Responsible Party):
Temple University Identifier:
First received: September 14, 2005
Last updated: March 26, 2013
Last verified: January 2008
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.

Condition Intervention Phase
Obesity Metabolic Syndrome X Hyperlipidemia Hypertension Behavioral: Almond enriched diet Behavioral: Low fat caloric diet Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons

Resource links provided by NLM:

Further study details as provided by Temple University:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 123
Study Start Date: February 2005
Study Completion Date: October 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Almond enriched diet
Behavioral: Almond enriched diet
Subjects will consume 2 oz. of almond per day in addition to a low-fat diet
Other Name: AED
Active Comparator: 2
Low-fat diet
Behavioral: Low fat caloric diet
Low fat caloric diet
Other Name: LFD

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).

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00194428

United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Almond Board of California
Principal Investigator: Gary D Foster, PhD Temple University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Temple University Identifier: NCT00194428     History of Changes
Other Study ID Numbers: 802132
Study First Received: September 14, 2005
Last Updated: March 26, 2013

Keywords provided by Temple University:
Metabolic Syndrome,

Additional relevant MeSH terms:
Metabolic Syndrome X
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders processed this record on September 20, 2017