Obesity
Conditions
Keywords
cardiovascular disease, weight loss
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.
Interventions
OTHERhigh fat diet
high saturated fat no starch diet
low calorie low saturated fat low trans fat high fiber diet
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Brachial artery reactivity | 12 weeks |
Countries
United States
Outcome results
None listed