Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc

Study Overview
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Brief Summary
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The objective of the current study is to test the overarching hypothesis that the beef nutritive matrix is uniquely suited to direct dietary zinc to cellular compartments for improved metabolic function, leading to a greater effect on health outcomes. Specifically, whether beef, as a component of a healthy meal, will promote the absorption of zinc into cells, where the zinc will have greater effects on zinc-dependent metabolic processes supporting cardiovascular health. To maximize the observability of these beef-related effects, individuals who are 55- to 70-year-old who generally have a higher risk of zinc deficiency and cardiovascular disease will be enrolled.

Detailed Description
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This study will examine whether daily beef intake will promote the absorption of dietary zinc into cells, leading to improved cellular zinc status and microvascular function. The study design will be a crossover comparison of a mixed diet including green leafy vegetables, fruits, whole grains, seeds, and nuts; with beef versus non-meat sources of additional protein and zinc, over two 4-week metabolic study periods. Outcomes will include cellular zinc status determined by erythrocyte zinc tracer exchange (primary), and microvascular function expressed as reactive hyperemia index (RHI). Previous studies have demonstrated that zinc tracer exchange with red blood cells (RBC) is highly sensitive to changes in zinc nutriture. Thus, cellular zinc status will be determined using a novel and cost-effective adaptation of this approach, modeling zinc tracer exchange with freshly-sampled RBC. As intracellular zinc can regulate vascular tone, microvascular function will be measured, using digital peripheral tonometry, will be used as a functional index of both cellular zinc status and vascular health.

Official Title
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Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet, on Cellular Zinc Status and Vascular Function in Older Adults

Conditions
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Zinc Deficiency, Inflammation, Metabolic Diseases, Vascular Diseases

Intervention / Treatment
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* Other: Beef protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or postmenopausal female 55-70 years of age Women: lack of menses for at least two years. Subject is willing and able to comply with the study protocols. Subject is willing to participate in all study procedures Self-reported stable dose of prescribed medications for a minimum of 6 months BMI 18.5 - 29.9 kg/m2 Exclusion Criteria: Self-reported use of daily anticoagulation agents including aspirin, NSAIDs Prescribed metaformin, statins or medications known to interfere with zinc, protein, or lipid metabolism Vegan, Vegetarians, food faddists or those consuming a non-traditional diet (e.g. Adkins, Keto, Paleo, etc.) Fruit consumption ≥ 3 cups/day Regular consumption of strawberries (2-3 servings/week) Vegetable consumption ≥ 4 cups/day Coffee/tea ≥ 3 cups/day Dark chocolate ≥ 3 oz/day Alcohol intake greater than 2 drinks in a day for men, or 1 drink in a day for women. Self-reported restriction of physical activity due to a chronic health condition Self-reported chronic/routine high intensity exercise Self-reported diabetes Blood pressure ≥ 140/90 mm Hg Self-reported renal or liver disease Self-reported heart disease, which includes cardiovascular events and stroke Peripheral artery disease Raynaud's syndrome or disease Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT Self-reported cancer within past 5 years Self-reported malabsorption Unwillingness to stop any supplement use six weeks prior to study initiation, including multivitamin/mineral, powders, herbal, plant or botanical, pro- and prebiotics, and oil supplements. Smoking, vaping, cannabis use Current enrollee in a clinical research study.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover comparison of a mixed diet including green leafy vegetables, fruits, whole grains, seeds, and nuts; with beef versus non-meat sources of additional protein and zinc, over two 4-week metabolic study periods.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beef Protein<br>A beef stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy); | Other: Beef protein<br>* Animal protein source<br>|
| Active Comparator: Animal Protein<br>A control plant protein stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy); | Other: Beef protein<br>* Animal protein source<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microvascular function | microvascular function as measured by digital tonometry (EndoPAT2000) | 4 weeks | 
| intracellular zinc status | intracellular zinc status determined by erythrocyte zinc tracer exchange | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma lipids | Circulating level of total cholesterol, triglycerides, HDL cholesterol, non-HDL cholesterol, with LDL cholesterol (calculated) | 4 weeks | 
| plasma fatty acids | Circulating levels of non-esterified fatty acids | 4 weeks | 
| plasma oxylipins | enzyme and non-enzyme derived non-esterified fatty acid metabolites | 4 weeks |