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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194428
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 28, 2013
Almond Board of California
Information provided by (Responsible Party):
Temple University

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 cardiovascular risk factors in approximately 112 overweight and obese persons.

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

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
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
Study Start Date : February 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00194428

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United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Almond Board of California
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Principal Investigator: Gary D Foster, PhD Temple University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Temple University Identifier: NCT00194428    
Other Study ID Numbers: 802132
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: January 2008
Keywords provided by Temple University:
Metabolic Syndrome,
Additional relevant MeSH terms:
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Metabolic Syndrome
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders