High Fat Diet II on Weight Loss (HFD)
This study has been completed.
Sponsor:
Christiana Care Health Services
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00525850
First received: September 5, 2007
Last updated: August 1, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Other: high fat diet Other: low saturated fat diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Christiana Care Health Services:
Primary Outcome Measures:
- Weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Brachial artery reactivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2006 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
high saturated fat diet
|
Other: high fat diet
high saturated fat no starch diet
|
|
2
low calorie low saturated fat low trans fat high fiber diet
|
Other: low saturated fat diet
low calorie low saturated fat low trans fat high fiber diet
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525850
Locations
| United States, Delaware | |
| 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 |
More Information
No publications provided
| Responsible Party: | Angela DiSabatino, RN, MS, Manager, Cardiovascular Clinical Trials Program, Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT00525850 History of Changes |
| Other Study ID Numbers: | CCC26177 |
| Study First Received: | September 5, 2007 |
| Last Updated: | August 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Christiana Care Health Services:
|
cardiovascular disease weight loss |
Additional relevant MeSH terms:
|
Arteriosclerosis Atherosclerosis Cardiovascular Diseases Obesity Weight Loss Arterial Occlusive Diseases Vascular Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 23, 2013