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

NCT01404897 | Completed

• 1 other identifier: MM3274
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Dyslipidemia; Blood Pressure

Keywords

carbohydrate; DASH diet; blood pressure; cholesterol

Outcome Measures

Primary Outcomes (18)

• Total:HDL-cholesterol ratio

  4 weeks

• HDL-cholesterol

  4 weeks

• Apolipoprotein B

  4 weeks

• Apolipoprotein AI

  4 weeks

• Small LDL particles

  4 weeks

• Large HDL particles

  4 weeks

• Total:HDL-cholesterol ratio

  9 weeks

• Total:HDL-cholesterol ratio

  14 weeks

• HDL-cholesterol

  9 weeks

• HDL-cholesterol

  14 weeks

• Apolipoprotein B

  9 weeks

• Apolipoprotein B

  14 weeks

• Apolipoprotein AI

  9 weeks

• Apolipoprotein AI

  14 weeks

• Small LDL particles

  9 weeks

• Small LDL particles

  14 weeks

• Large HDL particles

  9 weeks

• Large HDL particles

  14 weeks

Secondary Outcomes (6)

• Blood Pressure

  End of each experimental diet (4 wks, 9 wks, and 14 wks)

• Triglycerides

  End of each experimental diet (4 wks, 9 wks, and 14 wks)

• Total Cholesterol

  End of each experimental diet (4 wks, 9 wks, and 14 wks)

• LDL-Cholesterol

  End 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)

Study Arms (3)

Dietary Intervention: Control Diet

EXPERIMENTAL

Other: Dietary Intervention

Dietary Intervention: DASH-based diet

EXPERIMENTAL

Other: Dietary Intervention

Dietary Intervention: Modified DASH diet

EXPERIMENTAL

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

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

Dietary Intervention: Control Diet

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• Dairy Management Inc.: collaborator

Study Sites (1)

Cholesterol Research Center, Children's Hospital Oakland Research Institute

Berkeley, California, 94705, United States

Location

Related Publications (1)

• Chiu S, Bergeron N, Williams PT, Bray GA, Sutherland B, Krauss RM. Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Am J Clin Nutr. 2016 Feb;103(2):341-7. doi: 10.3945/ajcn.115.123281. Epub 2015 Dec 30.

  PMID: 26718414 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Dyslipidemias

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Ronald M Krauss, MD

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 28, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

US (1)