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NCT01404897 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by UCSF Benioff Children's Hospital Oakland.

Completed
Registry status
NA
Development phase
36
Enrollment target

NCT01404897: Completed NA study, sponsored by UCSF Benioff Children's Hospital Oakland.

NCT01404897 is a NA study that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01404897, a NA study, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.

COMPLETED
Registry status
NA
Development phase
36 participants
Enrollment target

Study 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.

Interventions

  • OTHER Dietary Intervention

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2011-07
Est. Completion 2013-12
Phase NA

What the Registry Record Tells You About NCT01404897

The ClinicalTrials.gov registry entry for NCT01404897 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Dietary Intervention is the first listed.

NCT01404897 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01404897 about?

NCT01404897 is a clinical study titled "Effects of High Fruit, Vegetable, and Dairy Intake on Plasma Lipids and Blood Pressure in Healthy Individuals". 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 trig...

What is the current status of trial NCT01404897?

This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2011-07. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01404897?

The interventions under investigation include: Dietary Intervention (OTHER).

Who is sponsoring clinical trial NCT01404897?

This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.