NCT00852267

Brief Summary

The purpose of this study is to test whether replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will improve risk factors for cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

February 24, 2009

Last Update Submit

December 22, 2020

Conditions

HealthyCardiovascular DiseaseAtherogenic Dyslipidemia

Keywords

cholesteroldietproteincarbohydratesaturated fatLDL subclasshealthy volunteers

Outcome Measures

Primary Outcomes (5)

  • Total Cholesterol

    3 weeks, 8 weeks, and 13 weeks

  • Non-HDL Cholesterol

    3 weeks, 8 weeks, and 13 weeks

  • Apolipoprotein B

    3 weeks, 8 weeks, and 13 weeks

  • LDL-Cholesterol/HDL-Cholesterol

    3 weeks, 8 weeks, and 13 weeks

  • Apolipoprotein B/Apolipoprotein AI

    3 weeks, 8 weeks, and 13 weeks

Secondary Outcomes (3)

  • LDL peak diameter

    3 weeks, 8 weeks, and 13 weeks

  • LDL subclass 3 (LDL3)

    3 weeks, 8 weeks, and 13 weeks

  • HDL subclass 2 (HDL2)

    3 weeks, 8 weeks, and 13 weeks

Study Arms (3)

High CHO, High SatFat Diet

ACTIVE COMPARATOR
Other: High Carbohydrate, High Saturated Fat Diet

Low CHO, High SatFat Diet

EXPERIMENTAL
Other: Low Carbohydrate, High Saturated Fat Diet

Low CHO, Low SatFat Diet

EXPERIMENTAL
Other: Low Carbohydrate, Low Saturated Fat Diet

Interventions

High Carbohydrate, High Saturated Fat DietOTHER

50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)

High CHO, High SatFat Diet
Low Carbohydrate, High Saturated Fat DietOTHER

31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)

Low CHO, High SatFat Diet
Low Carbohydrate, Low Saturated Fat DietOTHER

31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)

Low CHO, Low SatFat Diet

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood pressure less than 150/90
  • Body mass index (BMI)≥ 20 and ≤ 35 kg/m2
  • Non-smoker
  • Agrees not to consume alcohol during the study
  • Agrees to abstain from taking dietary supplements during the study
  • LDL-cholesterol and total cholesterol \< 95th percentile for age and sex
  • Fasting triglycerides \< 500 mg/dL
  • Fasting glucose concentration \< 126 mg/dL
  • Hematocrit (HCT) ≥ 36%
  • At least three months of a weight-stable state (± 3% of body weight)

You may not qualify if:

  • Personal history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, diabetes, lung disease, bleeding disorder, liver or renal disease, HIV or of cancer (other than skin cancer) in the last five years
  • Taking drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent warfarin
  • Abnormal thyroid stimulating hormone (TSH)
  • Strength trains with resistance weights more than four hours per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cholesterol Research Center

Berkeley, California, 94705, United States

Location

Related Publications (1)

  • Mangravite LM, Chiu S, Wojnoonski K, Rawlings RS, Bergeron N, Krauss RM. Changes in atherogenic dyslipidemia induced by carbohydrate restriction in men are dependent on dietary protein source. J Nutr. 2011 Dec;141(12):2180-5. doi: 10.3945/jn.111.139477. Epub 2011 Oct 26.

    PMID: 22031660DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Ronald M Krauss, M.D.

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 26, 2009

Study Start

January 1, 2008

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations

US(1)