NCT04660877

Brief Summary

The goal of this project is to use a cross over design in young healthy male and female adults:

  1. 1.To determine the amino acid blood response to the acute ingestion of cheddar cheese in comparison to that of milk.
  2. 2.To determine the muscle mTORC1 response to the acute ingestion of cheddar cheese in comparison to that of milk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

December 1, 2020

Last Update Submit

June 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Response to cheese or milk ingestion

    blood amino acids area under the curve in response to acute stimulation of cheese or milk consumption

    Area under the curve 0-300min after ingestion

Secondary Outcomes (1)

  • Response to cheese or milk ingestion

    Change between 60min after ingestion and fasted response

Study Arms (2)

Cheddar chese

EXPERIMENTAL

Once enrolled, participants will either ingest 20 grams of protein from 1) cheese or 2) milk for the first Metabolic Study and then the other product when they return after the washout period (\~1 month) for Metabolic Study #2.

Dietary Supplement: Cheddar Cheese

Milk

ACTIVE COMPARATOR

Once enrolled, participants will ingest 20 grams of protein from 1) cheese or 2) milk for the first Metabolic Study and then the other product when they return after the washout period (\~1 month) for Metabolic Study #2.

Dietary Supplement: Milk

Interventions

Cheddar CheeseDIETARY_SUPPLEMENT

20g of protein from cheddar cheese

Cheddar chese
MilkDIETARY_SUPPLEMENT

20g of protein from milk

Milk

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-35y

You may not qualify if:

  • History of cardiovascular disease
  • History of endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
  • History of kidney disease or failure
  • History of liver disease
  • History of respiratory disease (acute upper respiratory infection, chronic lung disease)
  • History of stroke with motor disability
  • Use of anticoagulant therapy (e.g., Coumadin, heparin) including aspirin and fish oils within 7d of the first biopsy experiment
  • Elevated systolic blood pressure \>150 or a diastolic blood pressure \> 100
  • Smoking
  • Recent anabolic or corticosteroids use (within 12 weeks)
  • Pregnancy as determined by a pregnancy test
  • self report of lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Micah Drummond

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants take part in an experiment in which they consume cheese then at another time consume milk
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 9, 2020

Study Start

June 28, 2018

Primary Completion

August 20, 2019

Study Completion

August 20, 2019

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations