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

September 5, 2007
September 6, 2007
August 2, 2011
December 2006
September 2010   (Final data collection date for primary outcome measure)
Weight loss [ Time Frame: 12 weeks ]
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Complete list of historical versions of study NCT00525850 on Archive Site
Brachial artery reactivity [ Time Frame: 12 weeks ]
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High Fat Diet II on Weight Loss
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
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.
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Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Other: high fat diet
    high saturated fat no starch diet
  • Other: low saturated fat diet
    low calorie low saturated fat low trans fat high fiber diet
  • 1
    high saturated fat diet
    Intervention: Other: high fat diet
  • 2
    low calorie low saturated fat low trans fat high fiber diet
    Intervention: Other: low saturated fat diet
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2010
September 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Angela DiSabatino, RN, MS, Manager, Cardiovascular Clinical Trials Program, Christiana Care Health Services
Christiana Care Health Services
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Principal Investigator: James Hays, MD Christiana Care Health Services
Christiana Care Health Services
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP