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High Fat Diet II on Weight Loss (HFD)

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Services
  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
Weight Loss
Arterial Occlusive Diseases
Body Weight
Body Weight Changes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014