HealthyNCT00852267
Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
A study testing High Carbohydrate, High Saturated Fat Diet, Low Carbohydrate, High Saturated Fat Diet and Low Carbohydrate, Low Saturated Fat Diet in people with Healthy and Cardiovascular Disease, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cardiovascular Disease, Atherogenic Dyslipidemia
- What is being tested?
- High Carbohydrate, High Saturated Fat Diet, Low Carbohydrate, High Saturated Fat Diet and Low Carbohydrate, Low Saturated Fat Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cholesterol Research Center
Berkeley, California, 94705
About this study
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.
Read the detailed description
The primary aim of this study is to test the hypothesis that replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will have beneficial effects on components of atherogenic dyslipidemia and postprandial lipoprotein response and that these effects will be independent of saturated fat intake.
- Conditions
- Healthy, Cardiovascular Disease, Atherogenic Dyslipidemia
- Being tested
- High Carbohydrate, High Saturated Fat Diet, Low Carbohydrate, High Saturated Fat Diet, Low Carbohydrate, Low Saturated Fat Diet
- Keywords
- cholesterol, diet, protein, carbohydrate, saturated fat, LDL subclass, healthy volunteers
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Carbohydrate, High Saturated Fat DietOther
50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)
Low Carbohydrate, High Saturated Fat DietOther
31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)
Low Carbohydrate, Low Saturated Fat DietOther
31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)
| Study group | Role | What they receive |
|---|---|---|
| High CHO, High SatFat Diet | Active comparator | Not described Receives: Other: High Carbohydrate, High Saturated Fat Diet |
| Low CHO, High SatFat Diet | Experimental | Not described Receives: Other: Low Carbohydrate, High Saturated Fat Diet |
| Low CHO, Low SatFat Diet | Experimental | Not described Receives: Other: Low Carbohydrate, Low Saturated Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol
Measured: 3 weeks, 8 weeks, and 13 weeks
Non-HDL Cholesterol
Measured: 3 weeks, 8 weeks, and 13 weeks
Apolipoprotein B
Measured: 3 weeks, 8 weeks, and 13 weeks
LDL-Cholesterol/HDL-Cholesterol
Measured: 3 weeks, 8 weeks, and 13 weeks
Apolipoprotein B/Apolipoprotein AI
Measured: 3 weeks, 8 weeks, and 13 weeks
Secondary outcomes (3)
LDL peak diameter
Measured: 3 weeks, 8 weeks, and 13 weeks
LDL subclass 3 (LDL3)
Measured: 3 weeks, 8 weeks, and 13 weeks
HDL subclass 2 (HDL2)
Measured: 3 weeks, 8 weeks, and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Sponsor
- Investigators
- Ronald M Krauss, M.D., Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852267
- Sponsor's protocol ID
- 2007-068
- Status last verified
- Dec 2020
- First submitted
- 24 Feb 2009
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22031660
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
- ClinicalTrials.gov ID
- NCT00852267
- Acronym / sponsor ID
- 2007-068
- Conditions
- Healthy, Cardiovascular Disease, Atherogenic Dyslipidemia
- Keywords
- cholesterol, diet, protein, carbohydrate, saturated fat, LDL subclass, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- Jan 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of this study is to test the hypothesis that replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will have beneficial effects on components of atherogenic dyslipidemia and postprandial lipoprotein response and that these effects will be independent of saturated fat intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Carbohydrate, High Saturated Fat Diet50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat) | Other | High CHO, High SatFat Diet |
| Low Carbohydrate, High Saturated Fat Diet31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat) | Other | Low CHO, High SatFat Diet |
| Low Carbohydrate, Low Saturated Fat Diet31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat) | Other | Low CHO, Low SatFat Diet |
Primary outcome
Total Cholesterol
Time frame: 3 weeks, 8 weeks, and 13 weeks
Non-HDL Cholesterol
Time frame: 3 weeks, 8 weeks, and 13 weeks
Apolipoprotein B
Time frame: 3 weeks, 8 weeks, and 13 weeks
LDL-Cholesterol/HDL-Cholesterol
Time frame: 3 weeks, 8 weeks, and 13 weeks
Apolipoprotein B/Apolipoprotein AI
Time frame: 3 weeks, 8 weeks, and 13 weeks
3 secondary outcomes
LDL peak diameter
Time frame: 3 weeks, 8 weeks, and 13 weeks
LDL subclass 3 (LDL3)
Time frame: 3 weeks, 8 weeks, and 13 weeks
HDL subclass 2 (HDL2)
Time frame: 3 weeks, 8 weeks, and 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Derived from this study: PubMed 22031660Mangravite 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M Krauss, M.D. principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Carbohydrate, High Saturated Fat Diet, Low Carbohydrate, High Saturated Fat Diet and Low Carbohydrate, Low Saturated Fat Diet in people with Healthy and Cardiovascular Disease, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (time frame: 3 weeks, 8 weeks, and 13 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.