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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital & Research Center Oakland
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01404897
First received: July 22, 2011
Last updated: July 30, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Total:HDL-cholesterol ratio [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein AI [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Small LDL particles [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Large HDL particles [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Total:HDL-cholesterol ratio [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Total:HDL-cholesterol ratio [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein AI [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein AI [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Small LDL particles [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Small LDL particles [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Large HDL particles [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Large HDL particles [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ] [ Designated as safety issue: No ]
  • Total Cholesterol [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ] [ Designated as safety issue: No ]
  • LDL-Cholesterol [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ] [ Designated as safety issue: No ]
  • Lipoprotein Subclasses (HDL, LDL, IDL, VLDL) [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ] [ Designated as safety issue: No ]
  • HOMA-IR [ Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 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

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404897

Contacts
Contact: Robin S Rawlings 510-665-0500 CRCinfo@chori.org

Locations
United States, California
Cholesterol Research Center, Children's Hospital Oakland Research Institute Recruiting
Berkeley, California, United States, 94705
Contact: Megan Bennett    510-665-0500    CRCinfo@chori.org   
Principal Investigator: Ronald M Krauss, MD         
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

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01404897     History of Changes
Other Study ID Numbers: MM3274
Study First Received: July 22, 2011
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014