- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04660877
Blood and Muscle Response to Cheddar Cheese in Healthy Adults
June 17, 2022 updated by: Micah Drummond, University of Utah
Anabolic Effects of Cheddar Cheese Consumption in Human Skeletal Muscle
The goal of this project is to use a cross over design in young healthy male and female adults:
- To determine the amino acid blood response to the acute ingestion of cheddar cheese in comparison to that of milk.
- To determine the muscle mTORC1 response to the acute ingestion of cheddar cheese in comparison to that of milk.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Each subject will take part in two metabolic studies.
Each metabolic study was designed to test the acute blood and muscle response to an ingested amount of either cheddar cheese or milk.
Approximately, one month after the first experiment (Metabolic Study #1), the participant will complete the second experiment (Metabolic Study #2) which was exact in design and at the same time of day as the first study but the participant ingested the alternate food product.
The morning of the metabolic studies, the participant will arrive at the clinical research center after a 10h fast.
A catheter will be placed in the participants' arm for blood sampling.
Next, the participant will undergo a fasted thigh skeletal muscle biopsy.
Following the muscle biopsy, the participant will consume either cheddar cheese (65g) or milk (370 mL) each amounting to 20g of protein.
Subsequent muscle biopsies will occur at 60 and 180min after product ingestion.
Blood sampling will occur in the fasted state and periodically after ingestion of the products (up to 300min).
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- The University of Utah
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 33 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 18-35y
Exclusion Criteria:
- 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
- Any other medical condition or event considered exclusionary by the PI and faculty physician
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cheddar chese
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.
|
20g of protein from cheddar cheese
|
Active Comparator: Milk
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.
|
20g of protein from milk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to cheese or milk ingestion
Time Frame: Area under the curve 0-300min after 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to cheese or milk ingestion
Time Frame: Change between 60min after ingestion and fasted response
|
muscle mTORC1 change in response to acute stimulation of cheese or milk
|
Change between 60min after ingestion and fasted response
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2018
Primary Completion (Actual)
August 20, 2019
Study Completion (Actual)
August 20, 2019
Study Registration Dates
First Submitted
December 1, 2020
First Submitted That Met QC Criteria
December 8, 2020
First Posted (Actual)
December 9, 2020
Study Record Updates
Last Update Posted (Actual)
June 22, 2022
Last Update Submitted That Met QC Criteria
June 17, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 110963
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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