NCT03179462

Brief Summary

The investigators will examine the effects of a given amount of a protein food source such as pork, mixed nuts, and tofu on anabolic response at the whole body and muscle levels in young, healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

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

June 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 30, 2021

Completed
Last Updated

December 6, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

June 5, 2017

Results QC Date

September 1, 2021

Last Update Submit

October 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Net Protein Synthesis Rate

    Net protein synthesis rate is determined in the 4.5-hours basal fasted period and 4-hours post-meal period over the 8.5-hour experimental period.

    Change from 4.5 to 8.5 hours.

Study Arms (3)

Pork intake

EXPERIMENTAL

Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.

Dietary Supplement: Pork intake

Mixed nuts intake

EXPERIMENTAL

Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.

Dietary Supplement: Mixed nuts intake

Tofu intake

EXPERIMENTAL

Subjects will consume 2 ounces of tofu following diet normalization for 3 days.

Dietary Supplement: Tofu intake

Interventions

Pork intakeDIETARY_SUPPLEMENT

Each participant will consume 2 ounces of cooked lean pork.

Pork intake
Mixed nuts intakeDIETARY_SUPPLEMENT

Each participant will consume 1 ounce of mixed nuts.

Mixed nuts intake
Tofu intakeDIETARY_SUPPLEMENT

Each participant will consume 2 ounces of tofu.

Tofu intake

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women, ages 18-40 years
  • BMI from 20 to 29.9 kg/m2

You may not qualify if:

  • Current diagnosis of diabetes
  • History of malignancy in the 6 months prior to enrollment
  • History of a chronic inflammatory condition or other chronic diseases (Lupus, HIV/AIDS, etc)
  • History of weight reduction surgery (Lapband, gastric sleeve, etc.)
  • Pregnant females
  • Subjects who do not or will not eat animal proteins
  • Subjects allergic to pork, tree or peanuts, or soybeans
  • Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
  • Subjects who report regular resistance training exercise \> one per week
  • Hemoglobin \< 9.5 g/dL at the screening visit
  • Platelets \< 250,000 at the screening visit
  • Concomitant use of corticosteroids (ingestion, injection or transdermal)
  • Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

Location

Results Point of Contact

Title
David D.Church, Ph.D.
Organization
University of Arkansas for Medical Sciences

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2017

First Posted

June 7, 2017

Study Start

December 1, 2017

Primary Completion

June 6, 2018

Study Completion

July 1, 2019

Last Updated

December 6, 2021

Results First Posted

September 30, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations