Effects of High Fruit, Vegetable, and Dairy Intake on Plasma Lipids and Blood Pressure in Healthy Individuals
Primary Purpose
Cardiovascular Disease, Dyslipidemia, Blood Pressure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Dietary Intervention
Dietary Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Disease focused on measuring carbohydrate, DASH diet, blood pressure, cholesterol
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
Sites / Locations
- Cholesterol Research Center, Children's Hospital Oakland Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dietary Intervention: Control Diet
Dietary Intervention: DASH-based diet
Dietary Intervention: Modified DASH diet
Arm Description
Outcomes
Primary Outcome Measures
Total:HDL-cholesterol ratio
HDL-cholesterol
Apolipoprotein B
Apolipoprotein AI
Small LDL particles
Large HDL particles
Total:HDL-cholesterol ratio
Total:HDL-cholesterol ratio
HDL-cholesterol
HDL-cholesterol
Apolipoprotein B
Apolipoprotein B
Apolipoprotein AI
Apolipoprotein AI
Small LDL particles
Small LDL particles
Large HDL particles
Large HDL particles
Secondary Outcome Measures
Blood Pressure
Triglycerides
Total Cholesterol
LDL-Cholesterol
Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)
HOMA-IR
Full Information
NCT ID
NCT01404897
First Posted
July 22, 2011
Last Updated
March 25, 2015
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Dairy Management Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01404897
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Dairy Management Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Dyslipidemia, Blood Pressure
Keywords
carbohydrate, DASH diet, blood pressure, cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Intervention: Control Diet
Arm Type
Experimental
Arm Title
Dietary Intervention: DASH-based diet
Arm Type
Experimental
Arm Title
Dietary Intervention: Modified DASH diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
3 weeks of a diet based on the Dietary Approaches to Stop Hypertension (DASH) diet plan. 57% carbohydrate, 18% protein, 25% fat.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat.
Primary Outcome Measure Information:
Title
Total:HDL-cholesterol ratio
Time Frame
4 weeks
Title
HDL-cholesterol
Time Frame
4 weeks
Title
Apolipoprotein B
Time Frame
4 weeks
Title
Apolipoprotein AI
Time Frame
4 weeks
Title
Small LDL particles
Time Frame
4 weeks
Title
Large HDL particles
Time Frame
4 weeks
Title
Total:HDL-cholesterol ratio
Time Frame
9 weeks
Title
Total:HDL-cholesterol ratio
Time Frame
14 weeks
Title
HDL-cholesterol
Time Frame
9 weeks
Title
HDL-cholesterol
Time Frame
14 weeks
Title
Apolipoprotein B
Time Frame
9 weeks
Title
Apolipoprotein B
Time Frame
14 weeks
Title
Apolipoprotein AI
Time Frame
9 weeks
Title
Apolipoprotein AI
Time Frame
14 weeks
Title
Small LDL particles
Time Frame
9 weeks
Title
Small LDL particles
Time Frame
14 weeks
Title
Large HDL particles
Time Frame
9 weeks
Title
Large HDL particles
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Blood Pressure
Time Frame
End of each experimental diet (4 wks, 9 wks, and 14 wks)
Title
Triglycerides
Time Frame
End of each experimental diet (4 wks, 9 wks, and 14 wks)
Title
Total Cholesterol
Time Frame
End of each experimental diet (4 wks, 9 wks, and 14 wks)
Title
LDL-Cholesterol
Time Frame
End of each experimental diet (4 wks, 9 wks, and 14 wks)
Title
Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)
Time Frame
End of each experimental diet (4 wks, 9 wks, and 14 wks)
Title
HOMA-IR
Time Frame
End of each experimental diet (4 wks, 9 wks, and 14 wks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Krauss, MD
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cholesterol Research Center, Children's Hospital Oakland Research Institute
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26718414
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.
Results Reference
derived
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Effects of High Fruit, Vegetable, and Dairy Intake on Plasma Lipids and Blood Pressure in Healthy Individuals
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