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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Obesity Metabolic Syndrome X Hyperlipidemia Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Almond enriched diet

Group Type EXPERIMENTAL

Almond enriched diet

Intervention Type BEHAVIORAL

Subjects will consume 2 oz. of almond per day in addition to a low-fat diet

2

Low-fat diet

Group Type ACTIVE_COMPARATOR

Low fat caloric diet

Intervention Type BEHAVIORAL

Low fat caloric diet

Interventions

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Almond enriched diet

Subjects will consume 2 oz. of almond per day in addition to a low-fat diet

Intervention Type BEHAVIORAL

Low fat caloric diet

Intervention Type BEHAVIORAL

Other Intervention Names

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AED LFD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes