Clinical trial NCT04660877: Blood and Muscle Response to Cheddar Cheese in Healthy Adults
Official title: Anabolic Effects of Cheddar Cheese Consumption in Human Skeletal Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants take part in an experiment in which they consume cheese then at another time consume milk
Primary purpose: BASIC_SCIENCE

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

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

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).

Eligibility criteria: Inclusion Criteria:

* Age between 18-35y

Exclusion Criteria:

1. History of cardiovascular disease
2. History of endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
3. History of kidney disease or failure
4. History of liver disease
5. History of respiratory disease (acute upper respiratory infection, chronic lung disease)
6. History of stroke with motor disability
7. Use of anticoagulant therapy (e.g., Coumadin, heparin) including aspirin and fish oils within 7d of the first biopsy experiment
8. Elevated systolic blood pressure \>150 or a diastolic blood pressure \> 100
9. Smoking
10. Recent anabolic or corticosteroids use (within 12 weeks)
11. Pregnancy as determined by a pregnancy test
12. self report of lactose intolerance
13. Any other medical condition or event considered exclusionary by the PI and faculty physician

Primary outcomes:
measure: Response to cheese or milk ingestion
timeFrame: Area under the curve 0-300min after ingestion
Secondary outcomes:
measure: Response to cheese or milk ingestion
timeFrame: Change between 60min after ingestion and fasted response
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Micah Drummond
role: PRINCIPAL_INVESTIGATOR
References: