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

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT00194428

Collaborator

Almond Board of California (Other)

123

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

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).

Study Design

Study Type:

Interventional

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 :

Feb 1, 2005

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

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 Names: AED
Active Comparator: 2 Low-fat diet	Behavioral: Low fat caloric diet Low fat caloric diet Other Names: LFD

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 Names:

AED

Active Comparator: 2

Low-fat diet

Behavioral: Low fat caloric diet

Low fat caloric diet

Other Names:

LFD

Outcome Measures

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 [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 [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

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