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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01404897
Enrollment
36
Registered
2011-07-28
Start date
2011-07-31
Completion date
2013-12-31
Last updated
2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Cardiovascular Disease, Dyslipidemia

Keywords

carbohydrate, DASH diet, blood pressure, cholesterol

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.

Interventions

OTHERDietary Intervention

3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.

Sponsors

Dairy Management Inc.
CollaboratorINDUSTRY
UCSF Benioff Children's Hospital Oakland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Large HDL particles4 weeks
Total:HDL-cholesterol ratio4 weeks
HDL-cholesterol4 weeks
Apolipoprotein B4 weeks
Apolipoprotein AI4 weeks
Small LDL particles4 weeks

Secondary

MeasureTime frame
Blood PressureEnd of each experimental diet (4 wks, 9 wks, and 14 wks)
TriglyceridesEnd of each experimental diet (4 wks, 9 wks, and 14 wks)
Total CholesterolEnd of each experimental diet (4 wks, 9 wks, and 14 wks)
LDL-CholesterolEnd of each experimental diet (4 wks, 9 wks, and 14 wks)
Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)End of each experimental diet (4 wks, 9 wks, and 14 wks)
HOMA-IREnd of each experimental diet (4 wks, 9 wks, and 14 wks)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026