Skip to main content
OpenTrials
Completed

NCT Number: NCT00525850

High Fat Diet II on Weight Loss

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Body Weight Changes Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health System

Newark, Delaware, 19718, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High fat diet

Other

high saturated fat no starch diet

low saturated fat diet

Other

low calorie low saturated fat low trans fat high fiber diet

Primary outcomes

  1. Weight loss

    Time frame: 12 weeks

Secondary outcomes

  1. Brachial artery reactivity

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study 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

Acronym: HFD

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 6, 2007
Registry last updated
Aug 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.