High Fat Diet II on Weight Loss
HFD
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Dec 2006
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 5, 2007
CompletedFirst Posted
Study publicly available on registry
September 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedAugust 2, 2011
August 1, 2011
3.8 years
September 5, 2007
August 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss
12 weeks
Secondary Outcomes (1)
Brachial artery reactivity
12 weeks
Study Arms (2)
1
OTHERhigh saturated fat diet
2
OTHERlow calorie low saturated fat low trans fat high fiber diet
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Christiana Care Health System
Newark, Delaware, 19718, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Hays, MD
Christiana Care Health Services
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 5, 2007
First Posted
September 6, 2007
Study Start
December 1, 2006
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
August 2, 2011
Record last verified: 2011-08