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

Study Overview
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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.

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).

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

Conditions
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Obesity, Metabolic Syndrome X, Hyperlipidemia, Hypertension

Intervention / Treatment
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* Behavioral: Almond enriched diet
* Behavioral: Low fat caloric diet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Almond enriched diet | Behavioral: Almond enriched diet<br>* Subjects will consume 2 oz. of almond per day in addition to a low-fat diet<br>* Other names: AED;|
| Active Comparator: 2<br>Low-fat diet | Behavioral: Low fat caloric diet<br>* Low fat caloric diet<br>* Other names: LFD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of the almond enriched diet on established and emerging surrogate markers of coronoary artery disease (CAD) risk |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, Obesity,, Metabolic Syndrome,