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 randomised cross-over design.

Official Title

Effect of High Saturated Fat No Starch Diet vs. Low Saturated Fat, Low Trans Fat, High Fibre Diet on Weight Loss and Markers of Atherosclerotic Cardiovascular Disease.

Conditions

  • Obesity

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

  • Weight loss

Secondary Outcome Measures:

  • Brachial artery reactivity

Study Start

December 2006

Eligibility & Criteria

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

Inclusion Criteria:

In order to qualify, participants must have metabolic syndrome:

  • Tiglycerides greater than 150 mg/dL
  • Bood 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 analysed for CBC, serum glucose and electrolytes, hepatic panel and TSH.

Exclusion Criteria:

  • Significant blood dyscrasia
  • Fasting glucose greater than 200 mg/dL
  • Creatine greater than 2 mg/dL
  • Significant electrolyte disorder
  • Hepatic functions greater than two times normal or abnormal TSH.

Total Enrolment

20

Contact Details

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

Contacts

Angela DiSabatino, RN, MS
302-733-2658
adisabatino@christianacare.org    

James Hays, MD 
302-733-2658      

Locations

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