Weight and Metabolic Effects of an Almond Enriched Hypoca... | NCT00194428

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

NCT00194428

Sponsor

Temple University

Status

Completed

Last Update Posted

Mar 28, 2013Estimated

Enrollment

123Actual

Phase

Phase 1Phase 2

Conditions

Obesity
Metabolic Syndrome X
Hyperlipidemia
Hypertension

Interventions

Almond enriched diet
Low fat caloric diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2009Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2013

Last Update Posted Date

Mar 28, 2013Estimated

Name	Class
Almond Board of California	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Almond enriched diet	Behavioral: Almond enriched diet
2	Active Comparator	Low-fat diet	Behavioral: Low fat caloric diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Almond enriched diet	Behavioral	Subjects will consume 2 oz. of almond per day in addition to a low-fat diet	1

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gary D Foster, PhD	Temple University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Temple University		Philadelphia	Pennsylvania	19140	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14624410	Background	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. doi: 10.1016/s0026-0495(03)00260-9.
14574348	Background

ID	Term
D009765	Obesity
D024821	Metabolic Syndrome
D006949	Hyperlipidemias
D006973	Hypertension

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases