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

Primary Purpose

Obesity, Metabolic Syndrome X, Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Almond enriched diet
Low fat caloric diet
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity,, Metabolic Syndrome,, BMI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Almond enriched diet

Low-fat diet

Outcomes

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

Secondary Outcome Measures

To evaluate the effects of the almond enriched diet on established and emerging surrogate markers of coronoary artery disease (CAD) risk

Full Information

First Posted
September 14, 2005
Last Updated
March 26, 2013
Sponsor
Temple University
Collaborators
Almond Board of California
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1. Study Identification

Unique Protocol Identification Number
NCT00194428
Brief Title
Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons
Official Title
Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Almond Board of California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome X, Hyperlipidemia, Hypertension
Keywords
Obesity,, Metabolic Syndrome,, BMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Almond enriched diet
Arm Title
2
Arm Type
Active Comparator
Arm Description
Low-fat diet
Intervention Type
Behavioral
Intervention Name(s)
Almond enriched diet
Other Intervention Name(s)
AED
Intervention Description
Subjects will consume 2 oz. of almond per day in addition to a low-fat diet
Intervention Type
Behavioral
Intervention Name(s)
Low fat caloric diet
Other Intervention Name(s)
LFD
Intervention Description
Low fat caloric diet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary D Foster, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14624410
Citation
Jenkins DJ, Kendall CW, Marchie A, Faulkner D, Vidgen E, Lapsley KG, Trautwein EA, Parker TL, Josse RG, Leiter LA, Connelly PW. The effect of combining plant sterols, soy protein, viscous fibers, and almonds in treating hypercholesterolemia. Metabolism. 2003 Nov;52(11):1478-83. doi: 10.1016/s0026-0495(03)00260-9.
Results Reference
background
PubMed Identifier
14574348
Citation
Wien MA, Sabate JM, Ikle DN, Cole SE, Kandeel FR. Almonds vs complex carbohydrates in a weight reduction program. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1365-72. doi: 10.1038/sj.ijo.0802411. Erratum In: Int J Obes Relat Metab Disord. 2004 Mar;28(3):459.
Results Reference
background
PubMed Identifier
22743313
Citation
Foster GD, Shantz KL, Vander Veur SS, Oliver TL, Lent MR, Virus A, Szapary PO, Rader DJ, Zemel BS, Gilden-Tsai A. A randomized trial of the effects of an almond-enriched, hypocaloric diet in the treatment of obesity. Am J Clin Nutr. 2012 Aug;96(2):249-54. doi: 10.3945/ajcn.112.037895. Epub 2012 Jun 27.
Results Reference
derived
Links:
URL
http://www.almondsarein.com
Description
Related Info
URL
http://www.almondboard.com
Description
Related Info

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

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