- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05236374
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet, on Cellular Zinc Status and Vascular Function in Older Adults
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roberta R Holt, PhD
- Phone Number: 15304005952
- Email: rrholt@ucdavis.edu
Study Contact Backup
- Name: Andrew Hall, PhD
- Email: aghall@ucdavis.edu
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Recruiting
- University of California, Davis; Department of Nutrition
-
Contact:
- Roberta Holt, PhD
- Phone Number: 530-752-4950
- Email: rrholt@ucdavis.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Beef Protein
A beef stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);
|
Animal protein source
|
|
Active Comparator: Animal Protein
A control plant protein stew, providing 8.8 mg zinc, 37.9 mg protein (approximately 500 kcal/d energy);
|
Animal protein source
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
microvascular function
Time Frame: 4 weeks
|
microvascular function as measured by digital tonometry (EndoPAT2000)
|
4 weeks
|
|
intracellular zinc status
Time Frame: 4 weeks
|
intracellular zinc status determined by erythrocyte zinc tracer exchange
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
plasma lipids
Time Frame: 4 weeks
|
Circulating level of total cholesterol, triglycerides, HDL cholesterol, non-HDL cholesterol, with LDL cholesterol (calculated)
|
4 weeks
|
|
plasma fatty acids
Time Frame: 4 weeks
|
Circulating levels of non-esterified fatty acids
|
4 weeks
|
|
plasma oxylipins
Time Frame: 4 weeks
|
enzyme and non-enzyme derived non-esterified fatty acid metabolites
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carl L Keen, PhD, Distinguished Professor Emeritus of Nutrition
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1806393
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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