A Randomized Study 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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- To 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
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant must be 18 - 64 years of age (inclusive) at the time of signing the informed consent.
- •Have a BMI range of 25.0 - 39.9 kg/m2 (inclusive).
- •In otherwise generally good health as determined by the investigator.
- •Have blood hs-CRP levels equal to or greater than 2.0 mg/L at screening.
- •Have the following conditions at screening:
- •Pre-diabetes (defined as an HbA1c of 5.7-6.4% \[inclusive\]), and/or
- •MetS, i.e., have 3 of the 5 following metabolic criteria:
- •A waist circumference of more than 40 inches (102 cm) in men and 35 inches (88 cm) in women
- •Serum triglycerides level of 150 mg/dL (1.7 mmol/L) or greater
- •Reduced HDL cholesterol, less than 40 mg/dL (1.0 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women
Exclusion Criteria
- •Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test at Visit
- •Have a known sensitivity, intolerability, or allergy to any of the components of the study dietary interventions and/or CGM sensor.
- •Have followed a ketogenic, Mediterranean, low-carbohydrate, vegetarian, vegan or any other special diet in the 6 months prior to screening.
- •Have been diagnosed with Type I or II diabetes or thyroid disease.
- •Have blood pressure of ≥ 160 systolic or ≥ 100 diastolic mmHg.
- •Have a history or current diagnosis of eating disorders such as anorexia or bulimia.
- •Have current symptoms, or symptoms within the past 7 days, of an acute infection (e.g., fever, respiratory symptoms such as persistent cough or difficulty breathing), that may influence study outcomes as assessed by the investigator.
- •Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of protein, fat, or micronutrients (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
- •Have a history of gallbladder disease (e.g., cholelithiasis, cholecystitis), cholecystectomy, gout, or kidney stones.
- •Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
Arms & Interventions
Healthy U.S.-Style Dietary Pattern
This diet is based on USDA's MyPlate dietary guidelines and includes a balanced intake of fruits, vegetables, whole grains, lean proteins, and low-fat dairy. This diet reflects a conventional, guideline-based approach to healthy eating.
Intervention: Healthy U.S.-Style Dietary Pattern (Other)
Healthy Beef-Centric Diet
This 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.
Intervention: Healthy Beef-Centric Diet (Other)
Outcomes
Primary Outcomes
To 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
Time Frame: Baseline to Week 5
Change from baseline to Week 5 in inflammatory marker composite (combination of hs-CRP, IL-6, IL-10, IL-1β, and TNF-α)
Secondary Outcomes
- 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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(Baseline to Week 5)