Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 9, 2026
February 1, 2026
4.3 years
February 2, 2022
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
plasma lipids
4 weeks
plasma fatty acids
4 weeks
plasma oxylipins
4 weeks
Study Arms (2)
Beef Protein
EXPERIMENTALA beef stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);
Animal Protein
ACTIVE COMPARATORA control plant protein stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis; Department of Nutrition
Davis, California, 95616, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl L Keen, PhD
Distinguished Professor Emeritus of Nutrition
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2022
First Posted
February 11, 2022
Study Start
October 1, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share