High Fat Diet II on Weight Loss - Full Text View

Sponsored by:	Christiana Care Health Services
Information provided by:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT00525850

Purpose

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.

Condition	Intervention
Obesity	Other: high fat diet Other: low saturated fat diet

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Starch

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effect of High Saturated Fat No Starch Diet vs. Low Saturated Fat, Low Trans Fat, High Fiber Diet on Weight Loss and Markers of Atherosclerotic Cardiovascular Disease

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:

Weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Brachial artery reactivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	December 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 high saturated fat diet	Other: high fat diet high saturated fat no starch diet
2 low calorie low saturated fat low trans fat high fiber diet	Other: low saturated fat diet low calorie low saturated fat low trans fat high fiber diet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525850

Locations

United States, Delaware
Christiana Care Health System
Newark,, Delaware, United States, 19718

Sponsors and Collaborators

Christiana Care Health Services

Investigators

Principal Investigator:

James Hays, MD

Christiana Care Health System

More Information

Responsible Party:	Christiana Care Health Services ( Angela DiSabatino, RN, MS, Manager, Cardiovascular Clinical Trials Program )
Study ID Numbers:	CCC26177
Study First Received:	September 5, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00525850
Health Authority:	United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:

cardiovascular disease
weight loss

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009