Dose-dependent Identification of Unique Biomarkers

Sponsor
San Diego State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05600348
Collaborator
(none)
22
3
24

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Pork Consumption
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
3 conditions, order randomly allocated3 conditions, order randomly allocated
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Personalized Pork: Dose-dependent Identification of Unique Biomarkers
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Metabolic biomarker discovery [4 weeks]

    Biomolecules detected through metabolomic profiling that will result in discovery of a metabolic signature for pork intake

Secondary Outcome Measures

  1. Fasted Glucose [4 weeks]

  2. Insulin [4 weeks]

  3. HDL Cholesterol [4 weeks]

  4. Total Cholesterol [4 weeks]

  5. LDL-Cholesterol [4 weeks]

  6. Triglycerides [4 weeks]

  7. Interleukin-6 [4 weeks]

  8. C-Reactive Protein [4 weeks]

  9. Blood Pressure [4 weeks]

    Systolic and Diastolic

  10. Body Composition [4 weeks]

    Weight measured via scalre, body fat% muscle mass as measured via DEXA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • San Diego State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shirin Hooshmand, Professor, San Diego State University
ClinicalTrials.gov Identifier:
NCT05600348
Other Study ID Numbers:
  • 5A949A
First Posted:
Oct 31, 2022
Last Update Posted:
Oct 31, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shirin Hooshmand, Professor, San Diego State University

Study Results

No Results Posted as of Oct 31, 2022