Metabolic SyndromeNCT03202680
Lean Beef Consumption and Insulin Sensitivity in Men and Women With Risk Factors for Diabetes
A study testing USDA Style Diet and Lean Beef Diet in people with Metabolic Syndrome and PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The objective of this trial is to compare the effects of a healthy, lean beef diet and an average American, United States Department of Agriculture (USDA) style diet, that is low in saturated fatty acids (SFA), on insulin sensitivity in men and women with risk factors for diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Metabolic Syndrome, PreDiabetes
- What is being tested?
- USDA Style Diet and Lean Beef Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2017to 16 Jul 2019
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI of 25.0-39.9 kg/m2.
- Metabolic syndrome (exhibiting at least 3 out of 5 of the criteria) AND/OR prediabetes (either fingerstick glycated hemoglobin 5.7-6.4%, fasting fingerstick capillary glucose of 100-125 mg/dL, or 2-h post-prandial glucose of 140-199 mg/dL).
- Fasting LDL-C level <200 mg/dL and fasting TG level <400 mg/dL.
- Willingness to consume only study-related foods/beverages during each test period and consume all of the study foods provided for each day.
- Willingness to come to the clinic for study food pick-up as needed.
- Judged to be in general good health, aside from the inclusionary metabolic criteria for the study, on the basis of medical history and screening laboratory tests.
Who cannot join
- Atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound], history of myocardial infarction, angina, or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type 1 or type 2 diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
- Known allergy, sensitivity, or intolerance to any ingredients in the study foods (e.g., dairy, nuts, etc.).
- Uncontrolled hypertension.
- Recent history of cancer except for non-melanoma skin cancer.
- Recent change in body weight of ± 4.5 kg (10 lbs).
Show all 15Show fewer
- Unstable use of any antihypertensive medication.
- Recent use of medications intended to alter the lipid profile [e.g., bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, and/or proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors], weight-loss drugs or programs, systemic corticosteroid drugs, medications known to influence carbohydrate metabolism (e.g., adrenergic receptor blockers, diuretics, and/or hypoglycemic medications).
- Recent use of foods or dietary supplements known to influence lipid metabolism (e.g., omega-3 fatty acids supplements or fortified foods, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues at doses >400 mg/d and irregular or inconsistent use of Metamucil® or viscous fiber-containing supplements.
- Recent use of antibiotics.
- Pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Extreme dietary habits (e.g., very low carbohydrate diet, vegan, vegetarian, etc.) or unwillingness to consume study foods.
- Current or recent history or strong potential for drug or alcohol abuse.
- History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
- Recent exposure to any non-registered drug product.
Trial locations and contacts
1 site in 1 country.
United States1 site
MB Clinical Research, LLC
Boca Raton, Florida, 33487
About this study
Official title: A Randomized, Controlled-Feeding, Crossover Trial to Assess the Effects of Increasing Lean Beef Consumption Within a Healthy Dietary Pattern on Insulin Sensitivity in Men and Women With Risk Factors for Diabetes Mellitus.
The objective of this trial is to compare the effects of a healthy, lean beef diet and an average American, United States Department of Agriculture (USDA) style diet, that is low in saturated fatty acids (SFA), on insulin sensitivity in men and women with risk factors for diabetes mellitus.
Read the detailed description
This is a randomized, controlled, crossover study that includes two screening visits, one baseline visit, two 28-d test periods and an end-of-washout visit. A 2-week washout period will separate the two treatments. Subjects will be screened to identify metabolic syndrome and/or prediabetes at the screening visits. Eligible subjects will be randomly assigned to a test sequence (USDA/lean beef or lean beef/USDA diets) and the appropriate calorie menu within each test diet, which will be determined based on each subject's calculated energy needs for weight maintenance. Study foods will be dispensed, and subjects will be instructed to consume all of the foods in their entirety for the duration of each 28-d test period, and avoid consuming any additional food or drink items that has not been provided to them. Compliance will be assessed through a Food Deviation Log where subjects will record any non-study food/beverages consumed, and any portions of the study foods not consumed.
An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period, and fasting glucose and insulin will also be measured at screening and at the first test visit in each treatment period. Fasting blood samples will be collected for lipid profile and high-sensitivity C-reactive protein (hs-CRP) measurements at all treatment visits. Additionally, fasting blood will be drawn for measurement of apolipoprotein B and A1 and lipoprotein particles and subfractions at baseline and the end of each treatment period.
Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria, medication/supplement use, and adverse effects will be performed throughout the study.
- Conditions
- Metabolic Syndrome, PreDiabetes
- Being tested
- USDA Style Diet, Lean Beef Diet
- Medical subject headings
- Metabolic Syndrome, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USDA Style DietOther
USDA style healthy diet, low in saturated fats.
Lean Beef DietOther
A lean beef containing healthy diet, low in saturated fats.
| Study group | Role | What they receive |
|---|---|---|
| USDA Style Diet | Active comparator | Healthy, low saturated fat, United States Department of Agriculture (USDA) style diet. Receives: Other: USDA Style Diet |
| Lean Beef Diet | Experimental | Healthy, low saturated fat, high in lean beef diet. Receives: Other: Lean Beef Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity index (Si)
Differences in the change from baseline between test conditions (lean beef diet and USDA diet) in the insulin sensitivity index (Si) using the short IVGTT.
Measured: Up to 50 minutes - measured at baseline, and end of each treatment period.
Secondary outcomes (15)
Disposition index of pancreatic beta-cell function [Si x acute insulin response to intravenous glucose (AIRg)]
Percent change (or change) from baseline to the end of each test condition.
Measured: Up to 50 minutes - measured at baseline, and end of each treatment period.
Fractional glucose disappearance constant from t = 10-50 min (Kg)
Percent change (or change) from baseline to the end of each test condition.
Measured: Up to 50 minutes - measured at baseline, and end of each treatment period.
Homeostasis model assessment of beta cell function (HOMA%B) and insulin sensitivity (HOMA%S)
Percent change (or change) from baseline to the end of each test condition.
Measured: Up to 28 days for each treatment period.
Insulin sensitivity (HOMA%S)
Percent change (or change) from baseline to the end of each test condition.
Measured: Up to 28 days for each treatment period.
Total Cholesterol (TC)
Percent change (or change) in TC from baseline to the end of each test condition
Measured: Up to 28 days for each treatment period.
Low-density Lipoprotein Cholesterol (LDL-C)
Percent change (or change) in LDL-C from baseline to the end of each test condition
Measured: Up to 28 days for each treatment period.
High-density Lipoprotein Cholesterol (HDL-C)
Percent change (or change) in HDL-C from baseline to the end of each test condition
Measured: Up to 28 days for each treatment period.
Non-HDL-C
Percent change (or change) in Non-HDL-C from baseline to the end of each test condition
Measured: Up to 28 days for each treatment period.
Triglycerides (TG)
Percent change (or change) in TG from baseline to the end of each test condition
Measured: Up to 28 days for each treatment period.
TC/HDL-C ratio
Percent change (or change) in TC/HDL-C ratio from baseline to the end of each test condition
Measured: Up to 28 days for each treatment period.
High-sensitivity C-reactive protein (hs-CRP)
Percent change (or change) from baseline to the end of each test condition in levels of hs-CRP
Measured: Up to 28 days for each treatment period.
Resting, seated systolic and diastolic blood pressures
Percent change (or change) from baseline to the end of each test condition.
Measured: Up to 28 days for each treatment period.
Lipoprotein subfraction and particle concentrations.
Percent change (or change) in lipoprotein subfraction and particle concentrations from baseline to the end of each test condition.
Measured: Up to 28 days for each treatment period.
Apo B measurements.
Percent change (or change) in Apo B levels from baseline to the end of each test condition.
Measured: Up to 28 days for each treatment period.
Apo A1 measurements.
Percent change (or change) in Apo A1 levels from baseline to the end of each test condition.
Measured: Up to 28 days for each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start6 Jul 2017
- Primary completion16 Jul 2018
- Study completion16 Jul 2019
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 Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202680
- Sponsor's protocol ID
- MB-1606
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maki KC, Wilcox ML, Dicklin MR, Buggia M, Palacios OM, Maki CE, Kramer M. Substituting Lean Beef for Carbohydrate in a Healthy Dietary Pattern Does Not Adversely Affect the Cardiometabolic Risk Factor Profile in Men and Women at Risk for Type 2 Diabetes. J Nutr. 2020 Jul 1;150(7):1824-1833. doi: 10.1093/jn/nxaa116.
PubMed 32359153
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled-Feeding, Crossover Trial to Assess the Effects of Increasing Lean Beef Consumption Within a Healthy Dietary Pattern on Insulin Sensitivity in Men and Women With Risk Factors for Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT03202680
- Acronym / sponsor ID
- MB-1606
- Conditions
- Metabolic Syndrome, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- 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 objective of this trial is to compare the effects of a healthy, lean beef diet and an average American, United States Department of Agriculture (USDA) style diet, that is low in saturated fatty acids (SFA), on insulin sensitivity in men and women with risk factors for diabetes mellitus.
Detailed description
This is a randomized, controlled, crossover study that includes two screening visits, one baseline visit, two 28-d test periods and an end-of-washout visit. A 2-week washout period will separate the two treatments. Subjects will be screened to identify metabolic syndrome and/or prediabetes at the screening visits. Eligible subjects will be randomly assigned to a test sequence (USDA/lean beef or lean beef/USDA diets) and the appropriate calorie menu within each test diet, which will be determined based on each subject's calculated energy needs for weight maintenance. Study foods will be dispensed, and subjects will be instructed to consume all of the foods in their entirety for the duration of each 28-d test period, and avoid consuming any additional food or drink items that has not been provided to them. Compliance will be assessed through a Food Deviation Log where subjects will record any non-study food/beverages consumed, and any portions of the study foods not consumed.
An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period, and fasting glucose and insulin will also be measured at screening and at the first test visit in each treatment period. Fasting blood samples will be collected for lipid profile and high-sensitivity C-reactive protein (hs-CRP) measurements at all treatment visits. Additionally, fasting blood will be drawn for measurement of apolipoprotein B and A1 and lipoprotein particles and subfractions at baseline and the end of each treatment period.
Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria, medication/supplement use, and adverse effects will be performed throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| USDA Style Diet | Active comparator | Other: USDA Style DietHealthy, low saturated fat, United States Department of Agriculture (USDA) style diet. |
| Lean Beef Diet | Experimental | Other: Lean Beef DietHealthy, low saturated fat, high in lean beef diet. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI of 25.0-39.9 kg/m2.
- Metabolic syndrome (exhibiting at least 3 out of 5 of the criteria) AND/OR prediabetes (either fingerstick glycated hemoglobin 5.7-6.4%, fasting fingerstick capillary glucose of 100-125 mg/dL, or 2-h post-prandial glucose of 140-199 mg/dL).
- Fasting LDL-C level <200 mg/dL and fasting TG level <400 mg/dL.
- Willingness to consume only study-related foods/beverages during each test period and consume all of the study foods provided for each day.
- Willingness to come to the clinic for study food pick-up as needed.
Key exclusion criteria (15 listed)
- Atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound], history of myocardial infarction, angina, or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type 1 or type 2 diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
- Known allergy, sensitivity, or intolerance to any ingredients in the study foods (e.g., dairy, nuts, etc.).
- Uncontrolled hypertension.
- Recent history of cancer except for non-melanoma skin cancer.
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 |
|---|---|---|
| USDA Style DietUSDA style healthy diet, low in saturated fats. | Other | USDA Style Diet |
| Lean Beef DietA lean beef containing healthy diet, low in saturated fats. | Other | Lean Beef Diet |
Primary outcome
Change in insulin sensitivity index (Si)
Time frame: Up to 50 minutes - measured at baseline, and end of each treatment period.
Differences in the change from baseline between test conditions (lean beef diet and USDA diet) in the insulin sensitivity index (Si) using the short IVGTT.
15 secondary outcomes
Disposition index of pancreatic beta-cell function [Si x acute insulin response to intravenous glucose (AIRg)]
Time frame: Up to 50 minutes - measured at baseline, and end of each treatment period.
Fractional glucose disappearance constant from t = 10-50 min (Kg)
Time frame: Up to 50 minutes - measured at baseline, and end of each treatment period.
Homeostasis model assessment of beta cell function (HOMA%B) and insulin sensitivity (HOMA%S)
Time frame: Up to 28 days for each treatment period.
Insulin sensitivity (HOMA%S)
Time frame: Up to 28 days for each treatment period.
Total Cholesterol (TC)
Time frame: Up to 28 days for each treatment period.
Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Up to 28 days for each treatment period.
High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Up to 28 days for each treatment period.
Non-HDL-C
Time frame: Up to 28 days for each treatment period.
Triglycerides (TG)
Time frame: Up to 28 days for each treatment period.
TC/HDL-C ratio
Time frame: Up to 28 days for each treatment period.
High-sensitivity C-reactive protein (hs-CRP)
Time frame: Up to 28 days for each treatment period.
Resting, seated systolic and diastolic blood pressures
Time frame: Up to 28 days for each treatment period.
Lipoprotein subfraction and particle concentrations.
Time frame: Up to 28 days for each treatment period.
Apo B measurements.
Time frame: Up to 28 days for each treatment period.
Apo A1 measurements.
Time frame: Up to 28 days for each treatment period.
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 Jul 2019.
- Derived from this study: PubMed 32359153Maki KC, Wilcox ML, Dicklin MR, Buggia M, Palacios OM, Maki CE, Kramer M. Substituting Lean Beef for Carbohydrate in a Healthy Dietary Pattern Does Not Adversely Affect the Cardiometabolic Risk Factor Profile in Men and Women at Risk for Type 2 Diabetes. J Nutr. 2020 Jul 1;150(7):1824-1833. doi: 10.1093/jn/nxaa116.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USDA Style Diet and Lean Beef Diet in people with Metabolic Syndrome and PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research 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 6 inclusion and 15 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 Jul 2019. 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?
Change in insulin sensitivity index (Si) (time frame: Up to 50 minutes - measured at baseline, and end of each treatment period.). 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 NCT03202680, 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 Jul 2019.