HypercholesterolemiaBOLDNCT00937898
Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk
A study testing BOLD+ Diet and BOLD diet in people with Hypercholesterolemia and Hypertriglyceridemia, run by Penn State University.
Trial summary
The study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Hypertriglyceridemia
- What is being tested?
- BOLD+ Diet and BOLD diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Mar 2012
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 20 and < 37
- LDL-C level between the 50th and 90th percentile (±5% for assay variation) according to NHANES data for sex and age (ex. for men: 128-177 mg/dL and for women: 121-172 mg/dL)
- TG level < 150 mg/dL
Who cannot join
- self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
- high alcohol consumption (≥ 14 drinks/week)
- intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
- treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications
- vegetarian diet
- weight loss or gain ≥ 10% body weight in the previous 6 months,
- lactation, pregnancy, or desire to become pregnant during the study
About this study
Official title: BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
The study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease.
- Conditions
- Hypercholesterolemia, Hypertriglyceridemia
- Being tested
- BOLD+ Diet, BOLD diet
- Keywords
- lean beef, cholesterol, lipids, diet intervention
- Medical subject headings
- Hypercholesterolemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOLD+ DietDietary supplement
Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors
BOLD dietDietary supplement
Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease
| Study group | Role | What they receive |
|---|---|---|
| DASH Diet | Experimental | High fruit and vegetable, low sodium diet Receives: Dietary Supplement: BOLD+ Diet; Dietary Supplement: BOLD diet |
| Average American Diet | Active comparator | Typical American diet (16% protein, ~50% carbohydrate, 33% fat) Receives: Dietary Supplement: BOLD+ Diet; Dietary Supplement: BOLD diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipids (Total cholesterol, LDL-C, HDL-C, TG)
Measured: End of each 5 week diet period (weeks 5, 11, 17, 23)
Secondary outcomes (3)
Apolipoprotein levels
Measured: End of each 5 week diet period (weeks 5, 11, 17, 23)
Vascular function
Measured: End of each 5 week diet period (weeks 5, 11, 17, 23)
Oxidative Stress
Measured: End of each 5 week diet period (weeks 5, 11, 17, 23)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startAug 2007
- Primary completionAug 2011
- Study completionMar 2012
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 HypercholesterolemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937898
- Sponsor's protocol ID
- PKE101
- Acronym
- BOLD
- Status last verified
- Aug 2023
- First submitted
- 18 Jun 2009
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Roussell MA, Hill AM, Gaugler TL, West SG, Heuvel JP, Alaupovic P, Gillies PJ, Kris-Etherton PM. Beef in an Optimal Lean Diet study: effects on lipids, lipoproteins, and apolipoproteins. Am J Clin Nutr. 2012 Jan;95(1):9-16. doi: 10.3945/ajcn.111.016261. Epub 2011 Dec 14.
PubMed 22170364
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
- ClinicalTrials.gov ID
- NCT00937898
- Acronym / sponsor ID
- BOLD / PKE101
- Conditions
- Hypercholesterolemia, Hypertriglyceridemia
- Keywords
- lean beef, cholesterol, lipids, diet intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- Aug 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Jul 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 study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH Diet | Experimental | Dietary Supplement: BOLD+ Diet, Dietary Supplement: BOLD dietHigh fruit and vegetable, low sodium diet |
| Average American Diet | Active comparator | Dietary Supplement: BOLD+ Diet, Dietary Supplement: BOLD dietTypical American diet (16% protein, ~50% carbohydrate, 33% fat) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 20 and < 37
- LDL-C level between the 50th and 90th percentile (±5% for assay variation) according to NHANES data for sex and age (ex. for men: 128-177 mg/dL and for women: 121-172 mg/dL)
- TG level < 150 mg/dL
Key exclusion criteria (7 listed)
- self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
- high alcohol consumption (≥ 14 drinks/week)
- intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
- treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications
- vegetarian diet
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 |
|---|---|---|
| BOLD+ DietComparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors | Dietary supplement | Average American Diet, DASH Diet |
| BOLD dietComparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease | Dietary supplement | Average American Diet, DASH Diet |
Primary outcome
Lipids (Total cholesterol, LDL-C, HDL-C, TG)
Time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)
3 secondary outcomes
Apolipoprotein levels
Time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)
Vascular function
Time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)
Oxidative Stress
Time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)
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 21 Aug 2023.
- Derived from this study: PubMed 22170364Roussell MA, Hill AM, Gaugler TL, West SG, Heuvel JP, Alaupovic P, Gillies PJ, Kris-Etherton PM. Beef in an Optimal Lean Diet study: effects on lipids, lipoproteins, and apolipoproteins. Am J Clin Nutr. 2012 Jan;95(1):9-16. doi: 10.3945/ajcn.111.016261. Epub 2011 Dec 14.
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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.
Penny M Kris-Etherton, PhD principal investigator
Penn State University
Questions about this trial
What is this clinical trial studying?
A study testing BOLD+ Diet and BOLD diet in people with Hypercholesterolemia and Hypertriglyceridemia, run by Penn State University.
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 3 inclusion and 7 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Lipids (Total cholesterol, LDL-C, HDL-C, TG) (time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)). 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 NCT00937898, 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 21 Aug 2023.