High Fat Diet II on Weight Loss

Obesity Clinical Trial

— HFD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525850
• Other study ID #: CCC26177
• Status: Completed
• Phase: N/A
• First received: September 5, 2007
• Last updated: August 1, 2011
• Start date: December 2006
• Est. completion date: September 2010

Study information

• Verified date: August 2011
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Obesity
• Weight Loss

Intervention

Other:
• high fat diet
high saturated fat no starch diet
• low saturated fat diet
low calorie low saturated fat low trans fat high fiber diet

Locations

Country	Name	City	State
United States	Christiana Care Health System	Newark,	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		12 weeks	No
Secondary	Brachial artery reactivity		12 weeks	No