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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404897
• Other study ID #: MM3274
• Status: Completed
• Phase: N/A
• First received: July 22, 2011
• Last updated: March 25, 2015
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Disease
• Cardiovascular Diseases
• Dyslipidemia
• Dyslipidemias

Intervention

Other:
• Dietary Intervention
3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.
• Dietary Intervention
3 weeks of a diet based on the Dietary Approaches to Stop Hypertension (DASH) diet plan. 57% carbohydrate, 18% protein, 25% fat.
• Dietary Intervention
3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat.

Locations

Country	Name	City	State
United States	Cholesterol Research Center, Children's Hospital Oakland Research Institute	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland	Dairy Management Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total:HDL-cholesterol ratio		4 weeks	No
Primary	HDL-cholesterol		4 weeks	No
Primary	Apolipoprotein B		4 weeks	No
Primary	Apolipoprotein AI		4 weeks	No
Primary	Small LDL particles		4 weeks	No
Primary	Large HDL particles		4 weeks	No
Primary	Total:HDL-cholesterol ratio		9 weeks	No
Primary	Total:HDL-cholesterol ratio		14 weeks	No
Primary	HDL-cholesterol		9 weeks	No
Primary	HDL-cholesterol		14 weeks	No
Primary	Apolipoprotein B		9 weeks	No
Primary	Apolipoprotein B		14 weeks	No
Primary	Apolipoprotein AI		9 weeks	No
Primary	Apolipoprotein AI		14 weeks	No
Primary	Small LDL particles		9 weeks	No
Primary	Small LDL particles		14 weeks	No
Primary	Large HDL particles		9 weeks	No
Primary	Large HDL particles		14 weeks	No
Secondary	Blood Pressure		End of each experimental diet (4 wks, 9 wks, and 14 wks)	No
Secondary	Triglycerides		End of each experimental diet (4 wks, 9 wks, and 14 wks)	No
Secondary	Total Cholesterol		End of each experimental diet (4 wks, 9 wks, and 14 wks)	No
Secondary	LDL-Cholesterol		End of each experimental diet (4 wks, 9 wks, and 14 wks)	No
Secondary	Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)		End of each experimental diet (4 wks, 9 wks, and 14 wks)	No
Secondary	HOMA-IR		End of each experimental diet (4 wks, 9 wks, and 14 wks)	No