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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404897
First Posted: July 28, 2011
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
  Purpose
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.

Condition Intervention
Cardiovascular Disease Dyslipidemia Blood Pressure Other: Dietary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Total:HDL-cholesterol ratio [ Time Frame: 4 weeks ]
  • HDL-cholesterol [ Time Frame: 4 weeks ]
  • Apolipoprotein B [ Time Frame: 4 weeks ]
  • Apolipoprotein AI [ Time Frame: 4 weeks ]
  • Small LDL particles [ Time Frame: 4 weeks ]
  • Large HDL particles [ Time Frame: 4 weeks ]
  • Total:HDL-cholesterol ratio [ Time Frame: 9 weeks ]
  • Total:HDL-cholesterol ratio [ Time Frame: 14 weeks ]
  • HDL-cholesterol [ Time Frame: 9 weeks ]
  • HDL-cholesterol [ Time Frame: 14 weeks ]
  • Apolipoprotein B [ Time Frame: 9 weeks ]
  • Apolipoprotein B [ Time Frame: 14 weeks ]
  • Apolipoprotein AI [ Time Frame: 9 weeks ]
  • Apolipoprotein AI [ Time Frame: 14 weeks ]
  • Small LDL particles [ Time Frame: 9 weeks ]
  • Small LDL particles [ Time Frame: 14 weeks ]
  • Large HDL particles [ Time Frame: 9 weeks ]
  • Large HDL particles [ Time Frame: 14 weeks ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ]
  • Triglycerides [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ]
  • Total Cholesterol [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ]
  • LDL-Cholesterol [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ]
  • Lipoprotein Subclasses (HDL, LDL, IDL, VLDL) [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ]
  • HOMA-IR [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ]

Enrollment: 36
Study Start Date: July 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary Intervention: Control Diet Other: Dietary Intervention
3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.
Experimental: Dietary Intervention: DASH-based diet Other: Dietary Intervention
3 weeks of a diet based on the Dietary Approaches to Stop Hypertension (DASH) diet plan. 57% carbohydrate, 18% protein, 25% fat.
Experimental: Dietary Intervention: Modified DASH diet Other: Dietary Intervention
3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404897


Locations
United States, California
Cholesterol Research Center, Children's Hospital Oakland Research Institute
Berkeley, California, United States, 94705
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Dairy Management Inc.
Investigators
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01404897     History of Changes
Other Study ID Numbers: MM3274
First Submitted: July 22, 2011
First Posted: July 28, 2011
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Children's Hospital & Research Center Oakland:
carbohydrate
DASH diet
blood pressure
cholesterol

Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases