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

Temple University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypertension; Hyperlipidemia; Obesity; Metabolic Syndrome X

Treatments: Behavioral: Low fat caloric diet; Behavioral: Almond enriched diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00194428

802132

Details and patient eligibility

About

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.

Full 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).

Enrollment: 123 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

1

Experimental group

Description:

Almond enriched diet

Treatment:

Behavioral: Almond enriched diet

2

Active Comparator group

Description:

Low-fat diet

Treatment:

Behavioral: Low fat caloric diet