Dose-dependent Identification of Unique Biomarkers

December 12, 2023 updated by: Shirin Hooshmand, San Diego State University

Personalized Pork: Dose-dependent Identification of Unique Biomarkers

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92182
        • School of Exercise and Nutritional Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0 oz Pork
Participants receive 0 oz pork and 6 oz 50:50 blend of chicken and beef per day
Dietary supplement: Pork Consumption
Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.
Experimental: 3 oz Pork
Participants receive 3 oz pork and 3 oz 50:50 blend of chicken and beef per day
Dietary supplement: Pork Consumption
Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.
Experimental: 6 oz Pork
Participants receive 6 oz pork and 0 oz 50:50 blend of chicken and beef per day
Dietary supplement: Pork Consumption
Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic biomarker discovery
Time Frame: 4 weeks
Biomolecules detected through metabolomic profiling that will result in discovery of a metabolic signature for pork intake
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 4 weeks
Systolic and Diastolic
4 weeks
Body Composition
Time Frame: 4 weeks
Weight measured via scalre, body fat% muscle mass as measured via DEXA
4 weeks
Fasted Glucose
Time Frame: 4 weeks
Fasted Glucose
4 weeks
Insulin
Time Frame: 4 weeks
Insulin
4 weeks
HDL Cholesterol
Time Frame: 4 weeks
HDL Cholesterol
4 weeks
Total Cholesterol
Time Frame: 4 weeks
Total Cholesterol
4 weeks
LDL-Cholesterol
Time Frame: 4 weeks
LDL-Cholesterol
4 weeks
Triglycerides
Time Frame: 4 weeks
Triglycerides
4 weeks
Interleukin-6
Time Frame: 4 weeks
Interleukin-6
4 weeks
C-Reactive Protein
Time Frame: 4 weeks
C-Reactive Protein
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Investigators

  • Principal Investigator: Shirin Hooshmand, PhD, San Diego State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 22, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5A949A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Healthy

Clinical Trials on Pork Consumption

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe