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High Fat Diet II on Weight Loss (HFD)

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00525850
First received: September 5, 2007
Last updated: August 1, 2011
Last verified: August 2011

September 5, 2007
August 1, 2011
December 2006
September 2010   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00525850 on ClinicalTrials.gov Archive Site
Brachial artery reactivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
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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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00525850
CCC26177
No
Angela DiSabatino, RN, MS, Manager, Cardiovascular Clinical Trials Program, Christiana Care Health Services
Christiana Care Health Services
Not Provided
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