- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03202680
Lean Beef Consumption and Insulin Sensitivity in Men and Women With Risk Factors for Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Boca Raton, Florida, United States, 33487
- MB Clinical Research, LLC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: USDA Style Diet
Healthy, low saturated fat, United States Department of Agriculture (USDA) style diet.
|
USDA style healthy diet, low in saturated fats.
|
EXPERIMENTAL: Lean Beef Diet
Healthy, low saturated fat, high in lean beef diet.
|
A lean beef containing healthy diet, low in saturated fats.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 50 minutes - measured at baseline, and end of each treatment period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Percent change (or change) from baseline to the end of each test condition.
|
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.
|
Percent change (or change) from baseline to the end of each test condition.
|
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.
|
Percent change (or change) from baseline to the end of each test condition.
|
Up to 28 days for each treatment period.
|
Insulin sensitivity (HOMA%S)
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) from baseline to the end of each test condition.
|
Up to 28 days for each treatment period.
|
Total Cholesterol (TC)
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in TC from baseline to the end of each test condition
|
Up to 28 days for each treatment period.
|
Low-density Lipoprotein Cholesterol (LDL-C)
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in LDL-C from baseline to the end of each test condition
|
Up to 28 days for each treatment period.
|
High-density Lipoprotein Cholesterol (HDL-C)
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in HDL-C from baseline to the end of each test condition
|
Up to 28 days for each treatment period.
|
Non-HDL-C
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in Non-HDL-C from baseline to the end of each test condition
|
Up to 28 days for each treatment period.
|
Triglycerides (TG)
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in TG from baseline to the end of each test condition
|
Up to 28 days for each treatment period.
|
TC/HDL-C ratio
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in TC/HDL-C ratio from baseline to the end of each test condition
|
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.
|
Percent change (or change) from baseline to the end of each test condition in levels of hs-CRP
|
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.
|
Percent change (or change) from baseline to the end of each test condition.
|
Up to 28 days for each treatment period.
|
Lipoprotein subfraction and particle concentrations.
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in lipoprotein subfraction and particle concentrations from baseline to the end of each test condition.
|
Up to 28 days for each treatment period.
|
Apo B measurements.
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in Apo B levels from baseline to the end of each test condition.
|
Up to 28 days for each treatment period.
|
Apo A1 measurements.
Time Frame: Up to 28 days for each treatment period.
|
Percent change (or change) in Apo A1 levels from baseline to the end of each test condition.
|
Up to 28 days for each treatment period.
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MB-1606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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