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High Fat Diet II on Weight Loss (HFD)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high fat diet
low saturated fat diet
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring cardiovascular disease, weight loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Christiana Care Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

high saturated fat diet

low calorie low saturated fat low trans fat high fiber diet

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Brachial artery reactivity

Full Information

First Posted
September 5, 2007
Last Updated
August 1, 2011
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00525850
Brief Title
High Fat Diet II on Weight Loss
Acronym
HFD
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Christiana Care Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
cardiovascular disease, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
high saturated fat diet
Arm Title
2
Arm Type
Other
Arm Description
low calorie low saturated fat low trans fat high fiber diet
Intervention Type
Other
Intervention Name(s)
high fat diet
Intervention Description
high saturated fat no starch diet
Intervention Type
Other
Intervention Name(s)
low saturated fat diet
Intervention Description
low calorie low saturated fat low trans fat high fiber diet
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Brachial artery reactivity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hays, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark,
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

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High Fat Diet II on Weight Loss

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