Dose-dependent Identification of Unique Biomarkers

Healthy Clinical Trial

Official title:

Personalized Pork: Dose-dependent Identification of Unique Biomarkers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05600348
• Other study ID #: 5A949A
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to assess the dose-dependent impacts of the consumption of fresh pork on blood-borne metabolites (markers) following the controlled feeding of pork

Description:

Eligible participants will follow 3 randomly ordered 4-week feeding periods varying only with the consumption of 0, 3 or 6 oz of pork or a 50:50 blend of chicken and beef (6, 3 and 0 oz for respective trials to ensure similar total poultry/meat intake among trials).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• generally healthy (i.e., an absence of diagnosed chronic illnesses and inborn metabolic disorders)

• Age 18-65

• all races

• both sexes

• willingness to comply with the research diet requirements

Exclusion Criteria:

• special dietary needs (e.g., vegetarianism, gluten-free, etc.)

• use of medication known to influence metabolism

• smoking

• substance use

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Pork Consumption
Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.

Locations

Country	Name	City	State
United States	School of Exercise and Nutritional Sciences	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic biomarker discovery	Biomolecules detected through metabolomic profiling that will result in discovery of a metabolic signature for pork intake	4 weeks
Secondary	Fasted Glucose	Fasted Glucose	4 weeks
Secondary	Insulin	Insulin	4 weeks
Secondary	HDL Cholesterol	HDL Cholesterol	4 weeks
Secondary	Total Cholesterol	Total Cholesterol	4 weeks
Secondary	LDL-Cholesterol	LDL-Cholesterol	4 weeks
Secondary	Triglycerides	Triglycerides	4 weeks
Secondary	Interleukin-6	Interleukin-6	4 weeks
Secondary	C-Reactive Protein	C-Reactive Protein	4 weeks
Secondary	Blood Pressure	Systolic and Diastolic	4 weeks
Secondary	Body Composition	Weight measured via scalre, body fat% muscle mass as measured via DEXA	4 weeks