This randomized study will be conducted to compare the effect of a healthy beef-centric diet to a healthy U.S.-style dietary pattern on inflammation and other metabolic health outcomes in a metabolic syndrome and/or pre-diabetic population.
This study follows a randomized, open-label, parallel design to compare the effects of a healthy beef-centric diet to a healthy U.S.-style dietary pattern on inflammation and other metabolic health outcomes in a metabolic syndrome and/or pre-diabetic population. The comparator diet in this study is a U.S. Department of Agriculture (USDA) Healthy U.S.-Style Dietary Pattern, as outlined in the 2020 Dietary Guidelines for Americans, which emphasizes the consumption of nutrient-dense foods across all food groups in recommended amounts. This includes a variety of vegetables, fruits, whole grains, low-fat dairy, lean protein sources, and healthy oils, while limiting added sugars, saturated fats, and sodium. The test diet in this study involves a healthy beef-centric diet, where beef is the main source of protein. Participants will consume 70% of their daily energy intake from beef. The rest of their calories will come from other protein and fat sources (20%), along with a small amount (10%) from low-carbohydrate fruits (such as berries) and vegetables (like dark leafy greens). This diet excludes all grains. While the carbohydrate intake is low, it is slightly higher than that of a typical ketogenic diet. The healthy beef-centric diet is being investigated for its effects on metabolic health after a 5 week intervention period. This study will investigate whether a beef-centric diet will support management of glycemic control, inflammation, and lipid-related risk factors, while also enhancing quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
56
The TD is a whole-food dietary pattern that emphasizes beef as the primary source of protein. This diet is designed to reflect a low-carbohydrate, minimally processed eating pattern.
The CD is based on the USDA's MyPlate dietary guidelines and includes a balanced intake of fruits, vegetables, whole grains, lean proteins, and low-fat dairy. The CD reflects a conventional, guideline-based approach to healthy eating.
Apex Trials
Guelph, Ontario - on, Canada
RECRUITINGTo evaluate the effect of a healthy beef-centric diet on inflammation in a metabolic syndrome (MetS) and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in inflammatory marker composite (combination of hs-CRP, IL-6, IL-10, IL-1β, and TNF-α)
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on systolic blood pressure (SBP) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in SBP
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on diastolic blood pressure (DBP) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in DBP
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on body weight in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in body weight
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on body mass index (BMI) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in BMI
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on glucose control (fasting insulin serum) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the fasting insulin serum
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on glucose control (fasting glucose serum) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the fasting glucose serum
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on glycemic patterns in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in mean 72-hour interstitial glucose levels, as assessed by continuous glucose monitoring (CGM) over 3-day periods
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on quality of life in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in quality of life, as assessed by the Food Benefits Assessment (FBA) Questionnaire on a 5-point Likert Scale: items are scored from 1 (Never / Certainly not) to 5 (Always / Certainly). The scores are transformed on a scale from 0 to 100 with higher scores indicating higher positive impact and/or satisfaction from daily diet.
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on blood lipids (total cholesterol) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the total cholesterol parameter of an advanced lipid profile
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on blood lipids (high-density lipoprotein (HDL) cholesterol) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the HDL cholesterol parameter of an advanced lipid profile
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on blood lipids (low-density lipoprotein (LDL) cholesterol) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the LDL cholesterol parameter of an advanced lipid profile
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on blood lipids (HDL:LDL ratio) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the HDL:LDL ratio parameter of an advanced lipid profile
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on blood lipids (triglycerides) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the triglycerides parameter of an advanced lipid profile
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on blood lipids (apolipoprotein B (ApoB)) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the ApoB parameter of an advanced lipid profile
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on blood lipids (lipid fraction) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in the lipid fraction parameter of an advanced lipid profile
Time frame: Baseline to Week 5
To evaluate the effect of a healthy beef-centric diet on short-term average glucose control in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in average blood glucose, as assessed by fructosamine levels
Time frame: Baseline to Week 5
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