Completed

NCEP Diet and Aerobic Exercise Impact on Cholesterol Levels

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Study Aim

This study aims to evaluate the impact of the NCEP diet and aerobic exercise on your cholesterol levels as a preventive measure.

What is being tested

diet, fat-restricted

+ exercise

Behavioral
Who is being recruted

Hyperlipidemias+5

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 30 to 64 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: August 1991
See protocol details

Summary

Principal SponsorStanford University
Last updated: January 12, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1991

Actual date on which the first participant was enrolled.

BACKGROUND: The NCEP is a major public education program providing advice to physicians and the public on management and prevention of coronary heart disease. However, data supporting the advice are derived primarily from middle-aged men, with less data available for women and older individuals. Furthermore, there have been recent reports that when low saturated fat diets such as the NCEP Step One and NCEP Step Two diets, are followed, HDL-cholesterol is lowered as well as LDL-cholesterol. DESIGN NARRATIVE: Randomized, controlled, factorial design powered for men and women separately. One hundred eighty postmenopausal women, 45 through 64 years of age, and 197 men, 30 through 64 years of age, who had low high-density lipoprotein (HDL) cholesterol levels (< or =59 mg per deciliter in women and < or =44 mg per deciliter in men) and moderately elevated levels of low-density lipoprotein (LDL) cholesterol (>125 mg per deciliter but <210 mg per deciliter in women and >125 mg per deciliter but <190 mg per deciliter in men) were enrolled. The subjects were randomly assigned to aerobic exercise, the NCEP Step 2 diet, or diet plus exercise, or to a control group, which received no intervention. The four interventions were delivered for one year: usual care (written dietary materials only with delayed intervention optional), exercise only (supervised, progressive aerobic exercise program at least three times per week), diet only (group and individual dietary instruction on the NCEP Step One/Step Two diet delivered by registered dietitians), and diet plus exercise. At baseline and at the end of one year, measurements were made of blood lipids and lipoproteins, plasma glucose and insulin, glucose tolerance, blood pressure, body composition through hydrostatic weighing and waist and hip circumterences, aerobic fitness (VO2 max), and five unannounced 24-hr. recalls. The primary outcomes measured was HDL-cholesterol, major secondary endpoints included LDL-C, LDL-C/HDL-C ratio, and triglycerides.

NCT00000598
Principal SponsorStanford University
Last updated: January 12, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersCardiovascular DiseasesHeart DiseasesHypercholesterolemia

Criteria

Men with with LDL-cholesterol of 125-189 mg/dL and HDL-cholesterol below or equal to 44 mg/dL, and postmenopausal women, age 45 to 64, with LDL-cholesterol of 125 to 209 mg/dL and HDL-cholesterol below or equal to 59 mg/dL.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers