NCT06489886

Brief Summary

The study aims to evaluate if there is a difference between eating conventionally raised or organic chicken. The investigators will measure and compare the nutrient and hormone levels in the participant's blood and the muscle protein synthesis rate (the rate at which your body builds muscle) after eating chicken from different farming practices. This will help the investigators to understand if these farming practices impact muscle protein synthesis and overall health. Specific aim 1: Describe the post-prandial nutrient and hormonal profile in serum in the 3 hours following consumption of 100 grams (\~32g of protein) of boneless-skinless conventional vs. regenerative chicken breast meat. Specific aim 2: Compare the ability of boneless-skinless chicken breasts grown with these two farming practices to activate mTORC1-specific and whole muscle protein synthesis in an in vitro model of muscle.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress96%
Oct 2024Jun 2026

First Submitted

Initial submission to the registry

June 28, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 11, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

June 28, 2024

Last Update Submit

December 10, 2025

Conditions

Keywords

Muscle protein Synthesispost-prandial nutrient and hormonal profilefarming practices

Outcome Measures

Primary Outcomes (4)

  • post-prandial amino acid profile

    Serum samples are extracted with 1mL of modified Folch extraction, followed by vacuum centrifugation for drying. Dried samples will be reconstituted with 100 μl of 75% ACN/water. The supernatant is then injected into Aligent UPLC-QqQ for analysis of targeted free amino acids, short peptides, and other metabolites.

    Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal

  • post-prandial short peptide profile

    Serum samples are extracted with 1mL of modified Folch extraction, followed by vacuum centrifugation for drying. Dried samples will be reconstituted with 100 μl of 75% ACN/water. The supernatant is then injected into Aligent UPLC-QqQ for analysis of targeted free amino acids, short peptides, and other metabolites.

    Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal

  • Muscle protein synthesis

    To measure muscle protein synthesis, stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) will be used. C2C12Luc cells will be plated in 24-well plates and differentiated over 4 days. Differentiated C2C12 cells will be fasted by washing with PBS and then treating them with Test Media (20% DMEM) for 15 minutes. Fasted muscle cells will then be treated with Test Media containing 10% baseline or fed serum (from blood samples at 30, 60, 90,120 and 180 minutes after meal) for 3 hours. Cells will be collected in passive lysis buffer and firefly luciferase activity will be determined.

    Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal

  • mTORC1 specific protein synthesis

    To measure the ability of meal of chicken (conventional or regenerative) to activate mTORC1, stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5'TOP. 5'TOP mRNA, which specifically regulated by mTORC1 activity, will be used. Differentiated C2C12TOPLuc muscle cells in 24-well plates will be stimulated using the baseline or fed serum (from blood samples at 30, 60, 90,120 and 180 minutes after meal). The degree of mTORC1 activation will be determined as the difference in slopes between the baseline and fed sera.

    Baseline (0 hour) to 30, 60, 90, 120 and 180 minutes after consumed meal

Study Arms (2)

Conventional Chicken

EXPERIMENTAL

This arm will be given a meal of 100 grams (\~32g of protein) boneless-skinless conventional chicken breast meat together with 250mL of water

Other: Conventional Chicken

Regenerative Chicken

EXPERIMENTAL

This arm will be given a meal of 100 grams (\~32g of protein) boneless-skinless regenerative chicken breast meat together with 250mL of water

Other: Regenerative Chicken

Interventions

This arm will be given a meal of 100 grams (\~32g of protein) boneless-skinless convential chicken breast meat together with 250mL of water

Conventional Chicken

This arm will be given a meal of 100 grams (\~32g of protein) boneless-skinless regenerative chicken breast meat together with 250mL of water

Regenerative Chicken

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy active males and females (To be considered active, volunteers must meet the following American College of Sports Medicine's guideline for physical activity for healthy adults: performing at least 150 minutes per week of moderate-to-vigorous intensity physical activity.
  • Age18-30 years
  • Normal weight (BMI between 18 and 25 kg/m2

You may not qualify if:

  • Health or dietary restrictions that would prevent consumption of the test foods
  • Known food allergy to chicken
  • Anemia (low red blood cell count)
  • Overweight or obesity (BMI \> 25 kg/m2)
  • Receiving any medication that may interfere with the study
  • Metabolic or endocrine disorder that would affect the digestion, absorption, and/or physiological response to any of the nutrients ingested.
  • Currently not meeting the ACSM physical activity recommendations (IPAQ score \< 150 min/week of moderate-to-vigorous physical activity.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis CTSC Clinical Research Center

Sacramento, California, 95817, United States

Location

Related Publications (9)

  • Ruiz JR, Sui X, Lobelo F, Morrow JR Jr, Jackson AW, Sjostrom M, Blair SN. Association between muscular strength and mortality in men: prospective cohort study. BMJ. 2008 Jul 1;337(7661):a439. doi: 10.1136/bmj.a439.

    PMID: 18595904BACKGROUND
  • Srikanthan P, Karlamangla AS. Muscle mass index as a predictor of longevity in older adults. Am J Med. 2014 Jun;127(6):547-53. doi: 10.1016/j.amjmed.2014.02.007. Epub 2014 Feb 18.

    PMID: 24561114BACKGROUND
  • Schiaffino S, Dyar KA, Ciciliot S, Blaauw B, Sandri M. Mechanisms regulating skeletal muscle growth and atrophy. FEBS J. 2013 Sep;280(17):4294-314. doi: 10.1111/febs.12253. Epub 2013 Apr 17.

    PMID: 23517348BACKGROUND
  • Burd NA, West DW, Staples AW, Atherton PJ, Baker JM, Moore DR, Holwerda AM, Parise G, Rennie MJ, Baker SK, Phillips SM. Low-load high volume resistance exercise stimulates muscle protein synthesis more than high-load low volume resistance exercise in young men. PLoS One. 2010 Aug 9;5(8):e12033. doi: 10.1371/journal.pone.0012033.

    PMID: 20711498BACKGROUND
  • Chen L, Nelson DR, Zhao Y, Cui Z, Johnston JA. Relationship between muscle mass and muscle strength, and the impact of comorbidities: a population-based, cross-sectional study of older adults in the United States. BMC Geriatr. 2013 Jul 16;13:74. doi: 10.1186/1471-2318-13-74.

    PMID: 23865675BACKGROUND
  • Terzis G, Georgiadis G, Stratakos G, Vogiatzis I, Kavouras S, Manta P, Mascher H, Blomstrand E. Resistance exercise-induced increase in muscle mass correlates with p70S6 kinase phosphorylation in human subjects. Eur J Appl Physiol. 2008 Jan;102(2):145-52. doi: 10.1007/s00421-007-0564-y. Epub 2007 Sep 14.

    PMID: 17874120BACKGROUND
  • Tipton KD, Ferrando AA, Phillips SM, Doyle D Jr, Wolfe RR. Postexercise net protein synthesis in human muscle from orally administered amino acids. Am J Physiol. 1999 Apr;276(4):E628-34. doi: 10.1152/ajpendo.1999.276.4.E628.

    PMID: 10198297BACKGROUND
  • Srednicka-Tober D, Baranski M, Seal C, Sanderson R, Benbrook C, Steinshamn H, Gromadzka-Ostrowska J, Rembialkowska E, Skwarlo-Sonta K, Eyre M, Cozzi G, Krogh Larsen M, Jordon T, Niggli U, Sakowski T, Calder PC, Burdge GC, Sotiraki S, Stefanakis A, Yolcu H, Stergiadis S, Chatzidimitriou E, Butler G, Stewart G, Leifert C. Composition differences between organic and conventional meat: a systematic literature review and meta-analysis. Br J Nutr. 2016 Mar 28;115(6):994-1011. doi: 10.1017/S0007114515005073. Epub 2016 Feb 16.

    PMID: 26878675BACKGROUND
  • Davis H, Magistrali A, Butler G, Stergiadis S. Nutritional Benefits from Fatty Acids in Organic and Grass-Fed Beef. Foods. 2022 Feb 23;11(5):646. doi: 10.3390/foods11050646.

    PMID: 35267281BACKGROUND

Study Officials

  • Keith Baar, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which food. The interventions will be coded using a blinded alphabetical letter code (A, B). A delegate researcher (independent party not further involved in the study) will randomize all interventions using a computer-generated randomization list. The delegate will hand in the code-breaker to the principal investigator in a sealed envelope. The envelope will be stored in a locked filing cabinet in the principal investigator's office, which will also be locked when unoccupied. The envelope will be opened by the principal investigator after completing the analysis of blood samples.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants will consume a meal of chicken, which type (conventional vs. regenerative ) consumed will be randomized where neither the participant nor investigator will know which meal is being consumed. Each participant will repeat the protocol two times.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 8, 2024

Study Start

October 11, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations