NCT05600348

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 8, 2025

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

October 22, 2022

Last Update Submit

January 6, 2025

Conditions

Healthy

Keywords

MetabolomePorkMetabolite

Outcome Measures

Primary Outcomes (1)

  • Metabolic biomarker discovery

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

    4 weeks

Secondary Outcomes (10)

  • Fasted Glucose

    4 weeks

  • Insulin

    4 weeks

  • HDL Cholesterol

    4 weeks

  • Total Cholesterol

    4 weeks

  • LDL-Cholesterol

    4 weeks

  • +5 more secondary outcomes

Study Arms (3)

0 oz Pork

EXPERIMENTAL

Participants receive 0 oz pork and 6 oz 50:50 blend of chicken and beef per day

Dietary Supplement: Pork Consumption

3 oz Pork

EXPERIMENTAL

Participants receive 3 oz pork and 3 oz 50:50 blend of chicken and beef per day

Dietary Supplement: Pork Consumption

6 oz Pork

EXPERIMENTAL

Participants receive 6 oz pork and 0 oz 50:50 blend of chicken and beef per day

Dietary Supplement: Pork Consumption

Interventions

Pork ConsumptionDIETARY_SUPPLEMENT

Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.

0 oz Pork3 oz Pork6 oz Pork

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • special dietary needs (e.g., vegetarianism, gluten-free, etc.)
  • use of medication known to influence metabolism
  • smoking
  • substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Exercise and Nutritional Sciences

San Diego, California, 92182, United States

Location

Study Officials

  • Shirin Hooshmand, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: 3 conditions, order randomly allocated
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2022

First Posted

October 31, 2022

Study Start

January 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 8, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)