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

March 25, 2015 updated by: UCSF Benioff Children's Hospital Oakland

Effects of a Modified Lower Carbohydrate, Higher Fat DASH Diet Plan on Plasma Lipids, Lipoprotein Particle Size, and Blood Pressure in Healthy Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94705
        • Cholesterol Research Center, Children's Hospital Oakland Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dietary Intervention: Control Diet
Other: Dietary Intervention
3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.
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.
Other: Dietary Intervention
3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat.
Experimental: Dietary Intervention: DASH-based diet
Other: Dietary Intervention
3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.
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.
Other: Dietary Intervention
3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat.
Experimental: Dietary Intervention: Modified DASH diet
Other: Dietary Intervention
3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.
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.
Other: Dietary Intervention
3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total:HDL-cholesterol ratio
Time Frame: 4 weeks
4 weeks
HDL-cholesterol
Time Frame: 4 weeks
4 weeks
Apolipoprotein B
Time Frame: 4 weeks
4 weeks
Apolipoprotein AI
Time Frame: 4 weeks
4 weeks
Small LDL particles
Time Frame: 4 weeks
4 weeks
Large HDL particles
Time Frame: 4 weeks
4 weeks
Total:HDL-cholesterol ratio
Time Frame: 9 weeks
9 weeks
Total:HDL-cholesterol ratio
Time Frame: 14 weeks
14 weeks
HDL-cholesterol
Time Frame: 9 weeks
9 weeks
HDL-cholesterol
Time Frame: 14 weeks
14 weeks
Apolipoprotein B
Time Frame: 9 weeks
9 weeks
Apolipoprotein B
Time Frame: 14 weeks
14 weeks
Apolipoprotein AI
Time Frame: 9 weeks
9 weeks
Apolipoprotein AI
Time Frame: 14 weeks
14 weeks
Small LDL particles
Time Frame: 9 weeks
9 weeks
Small LDL particles
Time Frame: 14 weeks
14 weeks
Large HDL particles
Time Frame: 9 weeks
9 weeks
Large HDL particles
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Blood Pressure
Time Frame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
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)
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)
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)
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)
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)
End of each experimental diet (4 wks, 9 wks, and 14 wks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCSF Benioff Children's Hospital Oakland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dairy Management Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MM3274

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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