High Fat Diet II on Weight Loss (HFD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525850
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : August 2, 2011
Information provided by:
Christiana Care Health Services

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Other: high fat diet Other: low saturated fat diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
high saturated fat diet
Other: high fat diet
high saturated fat no starch diet
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

Primary Outcome Measures :
  1. Weight loss [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Brachial artery reactivity [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00525850

United States, Delaware
Christiana Care Health System
Newark,, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Principal Investigator: James Hays, MD Christiana Care Health Services

Responsible Party: Angela DiSabatino, RN, MS, Manager, Cardiovascular Clinical Trials Program, Christiana Care Health Services Identifier: NCT00525850     History of Changes
Other Study ID Numbers: CCC26177
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: August 2011

Keywords provided by Christiana Care Health Services:
cardiovascular disease
weight loss

Additional relevant MeSH terms:
Cardiovascular Diseases
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Arterial Occlusive Diseases
Vascular Diseases