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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194428
• Other study ID #: 802132
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 14, 2005
• Last updated: March 26, 2013
• Start date: February 2005
• Est. completion date: October 2009

Study information

• Verified date: January 2008
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• Almond enriched diet
Subjects will consume 2 oz. of almond per day in addition to a low-fat diet
• Low fat caloric diet
Low fat caloric diet

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Almond Board of California

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Wien MA, Sabaté JM, Iklé 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. Erratum in: Int J Obes Relat Metab Disord. 2004 Mar;28(3):459. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the effects of the almond enriched diet on established and emerging surrogate markers of coronoary artery disease (CAD) risk		6 months	No

External Links

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