Clinical trial NCT01404897: Effects of High Fruit, Vegetable, and Dairy Intake on Plasma Lipids and Blood Pressure in Healthy Individuals
Official title: Effects of a Modified Lower Carbohydrate, Higher Fat DASH Diet Plan on Plasma Lipids, Lipoprotein Particle Size, and Blood Pressure in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Dyslipidemia
Blood Pressure
Keywords: carbohydrate
DASH diet
blood pressure
cholesterol
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
First posted: 2011-07-28
Enrollment: 36
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Total:HDL-cholesterol ratio
timeFrame: 4 weeks
measure: HDL-cholesterol
timeFrame: 4 weeks
measure: Apolipoprotein B
timeFrame: 4 weeks
measure: Apolipoprotein AI
timeFrame: 4 weeks
measure: Small LDL particles
timeFrame: 4 weeks
measure: Large HDL particles
timeFrame: 4 weeks
measure: Total:HDL-cholesterol ratio
timeFrame: 9 weeks
measure: Total:HDL-cholesterol ratio
timeFrame: 14 weeks
measure: HDL-cholesterol
timeFrame: 9 weeks
measure: HDL-cholesterol
timeFrame: 14 weeks
measure: Apolipoprotein B
timeFrame: 9 weeks
measure: Apolipoprotein B
timeFrame: 14 weeks
measure: Apolipoprotein AI
timeFrame: 9 weeks
measure: Apolipoprotein AI
timeFrame: 14 weeks
measure: Small LDL particles
timeFrame: 9 weeks
measure: Small LDL particles
timeFrame: 14 weeks
measure: Large HDL particles
timeFrame: 9 weeks
measure: Large HDL particles
timeFrame: 14 weeks
Secondary outcomes:
measure: Blood Pressure
timeFrame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
measure: Triglycerides
timeFrame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
measure: Total Cholesterol
timeFrame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
measure: LDL-Cholesterol
timeFrame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
measure: Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)
timeFrame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
measure: HOMA-IR
timeFrame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Cholesterol Research Center, Children's Hospital Oakland Research Institute
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Ronald M Krauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiu S, Bergeron N, Williams PT, Bray GA, Sutherland B, Krauss RM. Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Am J Clin Nutr. 2016 Feb;103(2):341-7. doi: 10.3945/ajcn.115.123281. Epub 2015 Dec 30.