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Completed

NCT Number: NCT01404897

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 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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cholesterol Research Center, Children's Hospital Oakland Research Institute

Berkeley, California, 94705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

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

Primary outcomes

  1. Total:HDL-cholesterol ratio

    Time frame: 4 weeks

  2. HDL-cholesterol

    Time frame: 4 weeks

  3. Apolipoprotein B

    Time frame: 4 weeks

  4. Apolipoprotein AI

    Time frame: 4 weeks

  5. Small LDL particles

    Time frame: 4 weeks

  6. Large HDL particles

    Time frame: 4 weeks

  7. Total:HDL-cholesterol ratio

    Time frame: 9 weeks

  8. Total:HDL-cholesterol ratio

    Time frame: 14 weeks

  9. HDL-cholesterol

    Time frame: 9 weeks

  10. HDL-cholesterol

    Time frame: 14 weeks

  11. Apolipoprotein B

    Time frame: 9 weeks

  12. Apolipoprotein B

    Time frame: 14 weeks

  13. Apolipoprotein AI

    Time frame: 9 weeks

  14. Apolipoprotein AI

    Time frame: 14 weeks

  15. Small LDL particles

    Time frame: 9 weeks

  16. Small LDL particles

    Time frame: 14 weeks

  17. Large HDL particles

    Time frame: 9 weeks

  18. Large HDL particles

    Time frame: 14 weeks

Secondary outcomes

  1. Blood Pressure

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

  2. Triglycerides

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

  3. Total Cholesterol

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

  4. LDL-Cholesterol

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

  5. Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)

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

  6. HOMA-IR

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

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • Dairy Management Inc.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 28, 2011
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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