Trial record 4 of 272 for:    Open Studies | dietary proteins

Dietary Protein Sources and Atherogenic Dyslipidemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital & Research Center Oakland
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01427855
First received: August 31, 2011
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

There is growing epidemiological evidence that consumption of red meat is associated with greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods. Research from our group has shown that a high saturated fat (SF) diet with a moderate red meat content selectively increases intermediate density lipoproteins (IDL) and larger low density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef consumption results in a preferential increase in small and medium LDL particles that are strongly related to CVD. To date, no studies have directly compared the lipoprotein effects of red meat with that of other food sources of protein in the context of both high and low saturated fat intake.

The overall objective of this project is to test the hypothesis that the effects of SF on lipoprotein markers of CVD risk are influenced by sources of dietary protein. The investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C), apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high content of red meat than in diets in which the major proteins are from white meat (poultry) or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and women will be randomized to high SF or low SF diet groups, and within each group, consume diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for 4 wks each in random order. Specifically, the investigators will test whether: (1) With high SF, the red meat diet, compared to the other protein sources, will result in higher levels of LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low SF, dietary protein source will not be related to any of these measurements; (3) With both the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due primarily to increases in large LDL, whereas with red meat the additional increase in small and medium LDL will result in greater increases in plasma apoB and total LDL particle number. Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat are related to increased activity of hepatic lipase, a key determinant of small LDL production, and that increases in large LDL induced by high SF are related to suppression of LDL receptors. The investigators will also assess the effects of protein source and saturated fat content on markers of insulin resistance, inflammation and endothelial function.


Condition Intervention
Cardiovascular Disease
Dyslipidemia
Insulin Resistance
Inflammation
Other: High saturated fat red meat diet
Other: High saturated fat non-meat diet
Other: High saturated fat white meat diet
Other: Low saturated fat red meat diet
Other: Low saturated fat white meat diet
Other: Low saturated fat non meat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Saturated Fat and Protein Effects on Atherogenic Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Change from baseline in LDL-Cholesterol [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in ApoB [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Small + Medium Sized LDL [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Total Cholesterol/HDL Cholesterol ratio [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in HDL-Cholesterol [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in non-HDLC [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in apoAI [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in apoAII [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HDL2 Cholesterol [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HDL3 Cholesterol [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR) [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in C-Reactive Protein [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Tumor Necrosis Factor-alpha [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Interleukin-6 [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Monocyte Chemotactic Protein-1 (MCP-1) [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in RH-PAT index [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Saturated Fat Red Meat Diet Other: High saturated fat red meat diet
4 weeks of a high saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (15% kcal from saturated fat))
Experimental: High Saturated Fat White Meat Diet Other: High saturated fat white meat diet
4 weeks of a high saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (15% kcal from saturated fat))
Experimental: High Saturated Fat Non-Meat Diet Other: High saturated fat non-meat diet
4 weeks of a high saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (15% kcal from saturated fat))
Experimental: Low Saturated Fat Red Meat Diet Other: Low saturated fat red meat diet
4 weeks of a low saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (7% kcal from saturated fat))
Experimental: Low Saturated Fat White Meat Diet Other: Low saturated fat white meat diet
4 weeks of a low saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (7% kcal from saturated fat))
Experimental: Low Saturated Fat Non-Meat Diet Other: Low saturated fat non meat diet
4 weeks of a low saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (7% kcal from saturated fat))

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 30-65 years old
  • 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 heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, lung disease, diabetes, Human immunodeficiency virus (HIV), or cancer (other than skin cancer) in the last 5 years
  • Body mass index (BMI) > 35 kg/m2 or < 20 kg/m2
  • Not weight stable
  • Abnormal thyroid stimulating hormone
  • Blood pressure > 150/90
  • Fasting blood sugar >126 mg/dl
  • Fasting triglyceride levels >500 mg/dl
  • Total- and LDL cholesterol >95th percentile for age and sex
  • Pregnant or breastfeeding
  • Taking hormones or drugs known to affect lipid metabolism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427855

Contacts
Contact: Daniela Molien, Study Coordinator 510-665-0506 CRCinfo@chori.org

Locations
United States, California
Cholesterol Research Center, Children's Hospital Research Institute Recruiting
Berkeley, California, United States, 94705
Contact: Daniela Molien    510-665-0506    CRCinfo@chori.org   
Contact: Megan Bennett    510-665-0500    CRCinfo@chori.org   
Principal Investigator: Ronald M Krauss, MD         
Principal Investigator: Nathalie Bergeron, PhD         
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland
Principal Investigator: Nathalie Bergeron, PhD Children's Hospital Oakland Research Institiute
  More Information

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01427855     History of Changes
Other Study ID Numbers: 1R01HL106003-01A1, 1R01HL106003-01A1
Study First Received: August 31, 2011
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Children's Hospital & Research Center Oakland:
Dietary Protein
Red Meat
White Meat
Vegetable Protein
Saturated Fat
LDL Subclasses
Cholesterol
Atherogenic Dyslipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Insulin Resistance
Dyslipidemias
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 01, 2014