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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.
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT00194428
First received: September 14, 2005
Last updated: March 26, 2013
Last verified: January 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194428

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00194428     History of Changes
Other Study ID Numbers: 802132
Study First Received: September 14, 2005
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Obesity,
Metabolic Syndrome,
BMI

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Obesity
Overweight
Metabolic Syndrome X
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
 Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on June 18, 2013