NCT05236374

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress85%
Oct 2022Dec 2026

First Submitted

Initial submission to the registry

February 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

February 2, 2022

Last Update Submit

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

EXPERIMENTAL

A beef stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);

Other: Beef protein

Animal Protein

ACTIVE COMPARATOR

A control plant protein stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);

Other: Beef protein

Interventions

Animal protein source

Animal ProteinBeef Protein

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

InflammationMetabolic DiseasesVascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutritional and Metabolic DiseasesCardiovascular Diseases

Study Officials

  • Carl L Keen, PhD

    Distinguished Professor Emeritus of Nutrition

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta R Holt, PhD

CONTACT

Andrew Hall, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
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

Locations