High Fat Diet II on Weight Loss

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: high fat diet; Other: low saturated fat diet

• Registration Number: NCT00525850
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-09-05
• Study First Submitted QC: 2007-09-05
• Study First Posted: 2007-09-06
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	high fat diet	high saturated fat diet
2	low saturated fat diet	low calorie low saturated fat low trans fat high fiber diet

Primary Outcome Measures

Name	Time	Method
Weight loss	12 weeks

Secondary Outcome Measures

Name	Time	Method
Brachial artery reactivity	12 weeks

Trial Locations

Locations (1)

Christiana Care Health System; 🇺🇸 Newark,, Delaware, United States