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

September 14, 2005
March 26, 2013
February 2005
October 2007   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00194428 on ClinicalTrials.gov Archive Site
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 ]
To evaluate the effects of the almond enriched diet on established and emerging surrogate markers of CAD risk.
Not Provided
Not Provided
 
Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons
Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons

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.

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Metabolic Syndrome X
  • Hyperlipidemia
  • Hypertension
  • Behavioral: Almond enriched diet
    Subjects will consume 2 oz. of almond per day in addition to a low-fat diet
    Other Name: AED
  • Behavioral: Low fat caloric diet
    Low fat caloric diet
    Other Name: LFD
  • Experimental: 1
    Almond enriched diet
    Intervention: Behavioral: Almond enriched diet
  • Active Comparator: 2
    Low-fat diet
    Intervention: Behavioral: Low fat caloric diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
October 2009
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00194428
802132
No
Temple University
Temple University
Almond Board of California
Principal Investigator: Gary D Foster, PhD Temple University
Temple University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP