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

Primary Purpose

Zinc Deficiency, Inflammation, Metabolic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beef protein
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Zinc Deficiency

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, Davis; Department of NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Beef Protein

Animal Protein

Arm Description

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

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

Outcomes

Primary Outcome Measures

microvascular function
microvascular function as measured by digital tonometry (EndoPAT2000)
intracellular zinc status
intracellular zinc status determined by erythrocyte zinc tracer exchange

Secondary Outcome Measures

plasma lipids
Circulating level of total cholesterol, triglycerides, HDL cholesterol, non-HDL cholesterol, with LDL cholesterol (calculated)
plasma fatty acids
Circulating levels of non-esterified fatty acids
plasma oxylipins
enzyme and non-enzyme derived non-esterified fatty acid metabolites

Full Information

First Posted
February 2, 2022
Last Updated
May 9, 2023
Sponsor
University of California, Davis
Collaborators
National Cattlemen's Beef Association
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1. Study Identification

Unique Protocol Identification Number
NCT05236374
Brief Title
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
Official Title
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet, on Cellular Zinc Status and Vascular Function in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Cattlemen's Beef Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zinc Deficiency, Inflammation, Metabolic Diseases, Vascular Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beef Protein
Arm Type
Experimental
Arm Description
A beef stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);
Arm Title
Animal Protein
Arm Type
Active Comparator
Arm Description
A control plant protein stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);
Intervention Type
Other
Intervention Name(s)
Beef protein
Intervention Description
Animal protein source
Primary Outcome Measure Information:
Title
microvascular function
Description
microvascular function as measured by digital tonometry (EndoPAT2000)
Time Frame
4 weeks
Title
intracellular zinc status
Description
intracellular zinc status determined by erythrocyte zinc tracer exchange
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
plasma lipids
Description
Circulating level of total cholesterol, triglycerides, HDL cholesterol, non-HDL cholesterol, with LDL cholesterol (calculated)
Time Frame
4 weeks
Title
plasma fatty acids
Description
Circulating levels of non-esterified fatty acids
Time Frame
4 weeks
Title
plasma oxylipins
Description
enzyme and non-enzyme derived non-esterified fatty acid metabolites
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta R Holt, PhD
Phone
15304005952
Email
rrholt@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Hall, PhD
Email
aghall@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl L Keen, PhD
Organizational Affiliation
Distinguished Professor Emeritus of Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis; Department of Nutrition
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Holt, PhD
Phone
530-752-4950
Email
rrholt@ucdavis.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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