HealthyNCT04660877
Blood and Muscle Response to Cheddar Cheese in Healthy Adults
A study testing Cheddar Cheese and Milk in people with Healthy, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cheddar Cheese and Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-35y
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Cheddar Cheese, Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheddar CheeseDietary supplement
20g of protein from cheddar cheese
MilkDietary supplement
20g of protein from milk
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to cheese or milk ingestion
blood amino acids area under the curve in response to acute stimulation of cheese or milk consumption
Measured: Area under the curve 0-300min after ingestion
Secondary outcomes (1)
Response to cheese or milk ingestion
muscle mTORC1 change in response to acute stimulation of cheese or milk
Measured: Change between 60min after ingestion and fasted response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start28 Jun 2018
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Participants take part in an experiment in which they consume cheese then at another time consume milk
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micah Drummond, University of Utah
- Investigators
- Micah Drummond, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660877
- Sponsor's protocol ID
- 110963
- Status last verified
- Jun 2022
- First submitted
- 1 Dec 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Effects of Cheddar Cheese Consumption in Human Skeletal Muscle
- ClinicalTrials.gov ID
- NCT04660877
- Acronym / sponsor ID
- 110963
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants take part in an experiment in which they consume cheese then at another time consume milk
| Arm | Type | Receives |
|---|---|---|
| Cheddar chese | Experimental | Dietary Supplement: Cheddar CheeseOnce 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. |
| Milk | Active comparator | Dietary Supplement: MilkOnce 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 18-35y
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cheddar Cheese20g of protein from cheddar cheese | Dietary supplement | Cheddar chese |
| Milk20g of protein from milk | Dietary supplement | Milk |
Primary outcome
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
1 secondary outcome
Response to cheese or milk ingestion
Time frame: Change between 60min after ingestion and fasted response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micah Drummond principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cheddar Cheese and Milk in people with Healthy, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to cheese or milk ingestion (time frame: Area under the curve 0-300min after ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.