Protein OverloadNCT03765710
Role of Dietary Protein Intake in Elderly Adults
A study testing Recommended protein intake and Elevated protein intake in people with Protein Overload, run by University of Arkansas.
Trial summary
The investigators examined the effects of dietary protein intake in a mixed meal at two levels of protein amount on whole body protein metabolisms in older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Protein Overload
- What is being tested?
- Recommended protein intake and Elevated protein intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 2016
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, ages > 60 years
Who cannot join
- History of diabetes
- History of malignancy in the 6 months prior to enrollment
- History of gastrointestinal bypass surgery (Lapband, etc)
- History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
- Pregnant females
- Subjects who do not or will not eat animal proteins
Show all 14Show fewer
- Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
- Subjects who report regular resistance exercise (more than once per week)
- Hemoglobin less than 9.5 mg/dL at the screening visit
- Platelets less than 150,000 at the screening visit
- Subjects who are not willing or able to suspend aspirin for several days prior to their muscle biopsies
- Subjects who have been prescribed a blood-thinning medication (Coumadin, lovenox, heparin, Plavix, etc.)
- 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
About this study
Official title: Role of Dietary Protein Intake on Whole Body Protein Balance in Elderly Adults
The investigators examined the effects of dietary protein intake in a mixed meal at two levels of protein amount on whole body protein metabolisms in older adults.
Read the detailed description
The investigators determined the total anabolic response to an amount of protein intake commonly eaten with dinner (70g) as compared with the amount required to maximally stimulate muscle protein synthesis (35g). Men and women, ages > 60 years will be studied under two levels of protein intake in mixed meals in random order (35g or 70g protein in isocaloric mixed meals). For two days prior to each stable isotope tracer study, subjects' dietary intake of calories and protein will be stabilized by providing subjects their entire diets. On the third day, a 8-hr metabolic study will be conducted in the UAMS Reynolds Institute on Aging (IOA) to determine the total anabolic response to the particular amount of beef intake, which will be repeated with the other amount of protein in mixed meal after a minimum 7-day washout interval. The investigators measured whole body protein kinetics, muscle fractional synthetic rate, and plasma amino acid profile.
- Conditions
- Protein Overload
- Being tested
- Recommended protein intake, Elevated protein intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommended protein intakeOther
Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.
Elevated protein intakeOther
Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.
| Study group | Role | What they receive |
|---|---|---|
| Recommended protein intake | Experimental | Subjects consumed a mixed meal with a macronutrient distribution of 13% protein, 54% carbohydrate, and 33% fat. Receives: Other: Recommended protein intake |
| Elevated protein intake | Experimental | Subjects consumed a mixed meal with a macronutrient distribution of 26% protein, 44% carbohydrate, and 30% fat. Receives: Other: Elevated protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in whole body anabolism
Whole body net protein balance in gram protein
Measured: Change before and after a mixed meal intake for approximately 8 hours
Changes in skeletal muscle synthetic rate
Skeletal muscle fractional synthetic rate in % synthesis
Measured: Change before and after a mixed meal intake for approximately 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein OverloadStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765710
- Sponsor's protocol ID
- 204291
- Status last verified
- Dec 2018
- First submitted
- 26 Nov 2018
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dietary Protein Intake on Whole Body Protein Balance in Elderly Adults
- ClinicalTrials.gov ID
- NCT03765710
- Acronym / sponsor ID
- 204291
- Conditions
- Protein Overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Dec 2018 (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 investigators examined the effects of dietary protein intake in a mixed meal at two levels of protein amount on whole body protein metabolisms in older adults.
Detailed description
The investigators determined the total anabolic response to an amount of protein intake commonly eaten with dinner (70g) as compared with the amount required to maximally stimulate muscle protein synthesis (35g). Men and women, ages > 60 years will be studied under two levels of protein intake in mixed meals in random order (35g or 70g protein in isocaloric mixed meals). For two days prior to each stable isotope tracer study, subjects' dietary intake of calories and protein will be stabilized by providing subjects their entire diets. On the third day, a 8-hr metabolic study will be conducted in the UAMS Reynolds Institute on Aging (IOA) to determine the total anabolic response to the particular amount of beef intake, which will be repeated with the other amount of protein in mixed meal after a minimum 7-day washout interval. The investigators measured whole body protein kinetics, muscle fractional synthetic rate, and plasma amino acid profile.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recommended protein intake | Experimental | Other: Recommended protein intakeSubjects consumed a mixed meal with a macronutrient distribution of 13% protein, 54% carbohydrate, and 33% fat. |
| Elevated protein intake | Experimental | Other: Elevated protein intakeSubjects consumed a mixed meal with a macronutrient distribution of 26% protein, 44% carbohydrate, and 30% fat. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women, ages > 60 years
Key exclusion criteria (14 listed)
- History of diabetes
- History of malignancy in the 6 months prior to enrollment
- History of gastrointestinal bypass surgery (Lapband, etc)
- History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
- Pregnant females
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 |
|---|---|---|
| Recommended protein intakeRecommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat. | Other | Recommended protein intake |
| Elevated protein intakeIncreased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat. | Other | Elevated protein intake |
Primary outcome
Changes in whole body anabolism
Time frame: Change before and after a mixed meal intake for approximately 8 hours
Whole body net protein balance in gram protein
Changes in skeletal muscle synthetic rate
Time frame: Change before and after a mixed meal intake for approximately 8 hours
Skeletal muscle fractional synthetic rate in % synthesis
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 26 Apr 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Recommended protein intake and Elevated protein intake in people with Protein Overload, run by University of Arkansas.
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 14 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 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in whole body anabolism (time frame: Change before and after a mixed meal intake for approximately 8 hours). The study lists 2 primary outcomes in all. 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 26 Apr 2023.