AzTrials
AzTrials

Metabolic SyndromeBOLD-XNCT00937638

Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome

A study testing BOLD Diet, BOLD-X Diet and Modified DASH Diet in people with Metabolic Syndrome and Cardiovascular Disease, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The proposed research will provide important information about the role of 2 intervention diets that provide different amounts of lean beef and meet current nutrient recommendations for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing in prevalence at alarming rates. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Metabolic Syndrome, Cardiovascular Disease
What is being tested?
BOLD Diet, BOLD-X Diet and Modified DASH Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteUnited States
Study dates
Feb 2009to 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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • (BMI 27-42 kg/m2)
  • Three or more of the following risk factors (defined as having MetSyn):
  • abdominal obesity [waist circumference > 102 cm (40 inches) in men and > 88 cm (35 inches) in women],
  • elevated blood glucose [> 110mg/dl (6.1 mmol/L)]
  • elevated TG [>150 mg/dl (1.7 mmol/L)]
  • low HDL-C [<40 mg/dl (1.03 mmol/L) in men and <50 mg/dL (1.29 mmol/l) in women]
  • hypertension (Systolic Blood Pressure > 130 mmHg or Diastolic Blood Pressure > 85 mmHg)*
  • BP medication accepted if BP stable and less than 160/100mm Hg

Who cannot join

  • A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
  • Lactation, pregnancy, or desire to become pregnant during the study
  • Intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
  • High alcohol consumption (≥ 14 drinks/week)
  • Participation in regular physical activity (> 1 formal session/week)
  • Lipid or glucose lowering medication

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors: Effects on Metabolic Syndrome (BOLD-X)

The proposed research will provide important information about the role of 2 intervention diets that provide different amounts of lean beef and meet current nutrient recommendations for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing in prevalence at alarming rates. The experimental and diet designs will enable us to evaluate lifestyle interventions for MetSyn for persons who maintain weight, lose weight and maintain their weight loss, as is currently recommended in clinical practice. Importantly, the investigators will compare a diet high in lean beef (5 oz/day) which is compositionally similar (i.e., energy and nutrients) to the modified-DASH diet, a low beef diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors, including MetSyn. In addition, the investigators also will evaluate a moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet, on CVD risk factors in persons with MetSyn. A follow-up study was conducted to assess dietary compliance in a sub-sample of the population at 12-months; participants were not informed of this end-point and additional consent was obtained.

Hypotheses:

  1. Healthful isocaloric diets that include lean beef as the primary source of protein (BOLD diet) with average (18%; BOLD) or moderate-high (28%; BOLD+) total protein intake will show similar or greater reductions in CVD risk, respectively when compared to a modified-DASH diet.
  2. A healthful weight-loss diet, including lean beef as the primary source of protein in a high-moderate protein diet (BOLD+ diet), plus regular exercise (BOLD+ + ex) will reduce body weight equal to that of a BOLD + ex and DASH + ex intervention, but may improve CV risk factors (such as BP and TG), and therefore reduce the prevalence of MetSyn more than a BOLD + ex and DASH + ex intervention.
  3. The BOLD diet will be more effective than the modified-DASH diet, and the BOLD+ diet more effective than the BOLD diet in maintaining the CVD benefits attained during phases 1 and 2. Dietary adherence will be better on the BOLD and BOLD + diets compared with the modified DASH diet.
Being tested
BOLD Diet, BOLD-X Diet, Modified DASH Diet
Keywords
Metabolic syndrome, Lean Beef, CVD
Medical subject headings
Metabolic Syndrome, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOLD DietDietary supplement

    Also called Low fat, Step II diet

    Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day)

  • BOLD-X DietDietary supplement

    Also called Low fat, moderate protein

    Low-fat, moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet. Also high in fruits and vegetables

  • Modified DASH DietDietary supplement

    Also called DASH diet

    Low-fat, high fruit and vegetable diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors and metabolic syndrome

Study groups in NCT00937638
Study groupRoleWhat they receive
Modified-DASH DietExperimentalNot described
Receives: Dietary Supplement: Modified DASH Diet
BOLD dietExperimentalNot described
Receives: Dietary Supplement: BOLD Diet
BOLD-XExperimentalNot described
Receives: Dietary Supplement: BOLD-X Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP

    Measured: 2 weeks

  2. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP

    Measured: 7 weeks

  3. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP

    Measured: 13 weeks

  4. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP

    Measured: 24 weeks

Secondary outcomes (14)

  1. Vascular endothelial function measured by endo-PAT

    Measured: 2 weeks

  2. Lipids and lipoproteins

    Measured: 2 weeks

  3. Inflammatory markers

    Measured: 2 weeks

  4. Vascular endothelial function measured by endo-PAT

    Measured: 7 weeks

  5. Vascular endothelial function measured by endo-PAT

    Measured: 13 weeks

  6. Vascular endothelial function measured by endo-PAT

    Measured: 24 weeks

  7. Lipids and lipoproteins

    Measured: 7 weeks

  8. Lipids and lipoproteins

    Measured: 13 weeks

  9. Lipids and lipoproteins

    Measured: 24 weeks

  10. Inflammatory markers

    Measured: 7 weeks

  11. Inflammatory markers

    Measured: 13 weeks

  12. Inflammatory markers

    Measured: 24 weeks

  13. Dietary analysis

    macro-and micronutrients

    Measured: 52 weeks

  14. Criteria for Metabolic Syndrome: central obesity (weight, waist circumference) TG, HDL-C, glucose and BP

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionAug 2011
  4. Study completionMar 2012

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00937638
Sponsor's protocol ID
PKE BOLD-X
Acronym
BOLD-X
Status last verified
Aug 2023
First submitted
18 Jun 2009
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
No

Publications

  • Hill AM, Harris Jackson KA, Roussell MA, West SG, Kris-Etherton PM. Type and amount of dietary protein in the treatment of metabolic syndrome: a randomized controlled trial. Am J Clin Nutr. 2015 Oct;102(4):757-70. doi: 10.3945/ajcn.114.104026. Epub 2015 Sep 9.

    PubMed 26354540

Questions about this trial

What is this clinical trial studying?

A study testing BOLD Diet, BOLD-X Diet and Modified DASH Diet in people with Metabolic Syndrome and Cardiovascular Disease, run by Penn State University 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 8 inclusion and 6 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.

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?

Criteria for Metabolic Syndrome: central obesity (weight, waist circumference, abdominal obesity), TG, HDL-C, glucose and BP (time frame: 2 weeks). The study lists 4 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 NCT00937638, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in