HealthyNCT05600348
Dose-dependent Identification of Unique Biomarkers
A study testing Pork Consumption in people with Healthy, run by San Diego State University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pork Consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- special dietary needs (e.g., vegetarianism, gluten-free, etc.)
- use of medication known to influence metabolism
- smoking
- substance use
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Exercise and Nutritional Sciences
San Diego, California, 92182
About this study
Official title: 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
Read the 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).
- Conditions
- Healthy
- Being tested
- Pork Consumption
- Keywords
- Metabolome, Pork, Metabolite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pork ConsumptionDietary supplement
Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.
| Study group | Role | What they receive |
|---|---|---|
| 0 oz Pork | Experimental | Participants receive 0 oz pork and 6 oz 50:50 blend of chicken and beef per day Receives: 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 Receives: 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 Receives: Dietary Supplement: Pork Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic biomarker discovery
Biomolecules detected through metabolomic profiling that will result in discovery of a metabolic signature for pork intake
Measured: 4 weeks
Secondary outcomes (10)
Fasted Glucose
Fasted Glucose
Measured: 4 weeks
Insulin
Insulin
Measured: 4 weeks
HDL Cholesterol
HDL Cholesterol
Measured: 4 weeks
Total Cholesterol
Total Cholesterol
Measured: 4 weeks
LDL-Cholesterol
LDL-Cholesterol
Measured: 4 weeks
Triglycerides
Triglycerides
Measured: 4 weeks
Interleukin-6
Interleukin-6
Measured: 4 weeks
C-Reactive Protein
C-Reactive Protein
Measured: 4 weeks
Blood Pressure
Systolic and Diastolic
Measured: 4 weeks
Body Composition
Weight measured via scalre, body fat% muscle mass as measured via DEXA
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jan 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3 conditions, order randomly allocated
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirin Hooshmand, San Diego State University
- Investigators
- Shirin Hooshmand, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600348
- Sponsor's protocol ID
- 5A949A
- Status last verified
- Dec 2023
- First submitted
- 22 Oct 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Pork: Dose-dependent Identification of Unique Biomarkers
- ClinicalTrials.gov ID
- NCT05600348
- Acronym / sponsor ID
- 5A949A
- Conditions
- Healthy
- Keywords
- Metabolome, Pork, Metabolite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 conditions, order randomly allocated
| Arm | Type | Receives |
|---|---|---|
| 0 oz Pork | Experimental | Dietary Supplement: Pork ConsumptionParticipants receive 0 oz pork and 6 oz 50:50 blend of chicken and beef per day |
| 3 oz Pork | Experimental | Dietary Supplement: Pork ConsumptionParticipants receive 3 oz pork and 3 oz 50:50 blend of chicken and beef per day |
| 6 oz Pork | Experimental | Dietary Supplement: Pork ConsumptionParticipants receive 6 oz pork and 0 oz 50:50 blend of chicken and beef per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- special dietary needs (e.g., vegetarianism, gluten-free, etc.)
- use of medication known to influence metabolism
- smoking
- substance use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pork ConsumptionFeeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order. | Dietary supplement | 0 oz Pork, 3 oz Pork, 6 oz Pork |
Primary outcome
Metabolic biomarker discovery
Time frame: 4 weeks
Biomolecules detected through metabolomic profiling that will result in discovery of a metabolic signature for pork intake
10 secondary outcomes
Fasted Glucose
Time frame: 4 weeks
Insulin
Time frame: 4 weeks
HDL Cholesterol
Time frame: 4 weeks
Total Cholesterol
Time frame: 4 weeks
LDL-Cholesterol
Time frame: 4 weeks
Triglycerides
Time frame: 4 weeks
Interleukin-6
Time frame: 4 weeks
C-Reactive Protein
Time frame: 4 weeks
Blood Pressure
Time frame: 4 weeks
Body Composition
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirin Hooshmand, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pork Consumption in people with Healthy, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic biomarker discovery (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.