High Fat Diet II on Weight Loss

NCT ID: NCT00525850

Last Updated: 2011-08-02

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

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-09-30

Brief Summary

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To evaluate two different diets and their effects on weight loss and measurements of several risk factors for cardiovascular disease. One diet will be a high saturated fat diet (HSFD) and the other is a low saturated fat diet (LSFD) that limits fat but especially saturated fat as red meat. All participants in this study must eat both diets as this is a randomized cross-over design.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

high saturated fat diet

Group Type OTHER

high fat diet

Intervention Type OTHER

high saturated fat no starch diet

2

low calorie low saturated fat low trans fat high fiber diet

Group Type OTHER

low saturated fat diet

Intervention Type OTHER

low calorie low saturated fat low trans fat high fiber diet

Interventions

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high fat diet

high saturated fat no starch diet

Intervention Type OTHER

low saturated fat diet

low calorie low saturated fat low trans fat high fiber diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

In order to qualify, participants must have metabolic syndrome:

* triglycerides greater than 150 mg/dL
* blood pressure greater than 130 mmHg and/or diastolic blood pressure greater than 85 mmHg
* fasting glucose greater than 110 mg/dL
* waist circumference greater than 40 inches in men or 35 inches in women
* reduced HDL less than 40 mg/dL in men and less than 50 mg/dL in women. Participants must be capable of performing symptom-limited maximal exercise capacity study. Blood and urine samples collected at baseline will be analyzed for CBC, serum glucose and electrolytes, hepatic panel and TSH.

Exclusion Criteria

Participants will be excluded for any significant blood dyscrasia, fasting glucose greater than 200 mg/dL, creatine greater than 2 mg/dL, any significant electrolyte disorder, hepatic functions greater than two times normal or abnormal TSH.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Christiana Care Health Services

Principal Investigators

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James Hays, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

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Christiana Care Health System

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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CCC26177

Identifier Type: -

Identifier Source: org_study_id

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