Effects of High Fruit, Vegetable, and Dairy Intake on Plasma Lipids and Blood Pressure in Healthy Individuals

Completed · Not applicable

Conditions studied: Cardiovascular Disease, Dyslipidemia, Blood Pressure

In brief

The Dietary Approaches to Stop Hypertension (DASH) trial has been shown to reduce blood pressure and plasma total and LDL-cholesterol (C) compared to a Western diet, but shows no benefit on other blood lipid variables associated with cardiovascular disease (CVD) risk, namely HDL-cholesterol and triglycerides. The overall objective of this study is to determine whether modification of the DASH diet by substituting carbohydrate with fat will result in improvements in multiple biomarkers of CVD risk. Specifically, the investigators will test the hypotheses that modification of the DASH diet by reducing carbohydrate, primarily in the form of simple sugars and glycemic starches, and allowing for a more liberal intake of total and saturated fat, primarily from dairy foods, will: (1) improve lipoprotein markers of CVD risk (reduced total/HDL-C ratio, apolipoprotein B, small LDL particles, and increased HDL-C, apoAI, and large HDL particles); and (2) result in comparable reductions of systolic and diastolic blood pressure to those achieved with the standard DASH diet. The investigators will also assess the effects of the modified DASH diet on markers of insulin resistance and inflammation. Our main hypotheses will be tested by a controlled dietary intervention conducted in 40 healthy men and women who will be randomly allocated to consume, for 3 weeks each, a control Western diet, a standard DASH diet, and a modified low-carbohydrate DASH diet, separated by 2-week washout periods.

Key facts

Study ID

NCT01404897

Run by

UCSF Benioff Children's Hospital Oakland

People needed

36

Starts

2011-07-01

Expected to finish

2013-12-01

Last updated by the study team

2015-03-26

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 22 years and older
• Average systolic blood pressure <160 mm Hg and diastolic blood pressure 80 - 95 mm Hg measured on 2 separate days
• Non-smoking
• Agrees to abstain from alcohol and dietary supplements during the study
• Willing to consume all study foods as instructed

You may not qualify if…

• History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
• Taking hormones or drugs known to affect lipid metabolism or blood pressure.
• Body Mass Index (BMI) > 35
• Total- and LDL-cholesterol > 95th percentile for sex and age.
• Fasting triglycerides > 500 mg/dl.
• Fasting blood sugar (FBS) > 126 mg/dl.
• Abnormal thyroid stimulating hormone
• Not weight stable
• Pregnant or breast-feeding

Where it is running

• Cholesterol Research Center, Children's Hospital Oakland Research Institute — Berkeley, California, United States

Full record on ClinicalTrials.gov

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