Nutrition Disorders in Old AgeNCT05610644
Impact of Time Restricted Feeding on Daily Protein Requirements
A study testing isocaloric, isonitrogenous meals in people with Nutrition Disorders in Old Age, run by University of Arkansas at 1 site in United States.
Trial summary
The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders in Old Age
- What is being tested?
- isocaloric, isonitrogenous meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 3 Oct 2024
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ages 50-75 years.
- BMI 20-30 kg/m2 inclusive.
- Capable of providing informed consent.
- COVID-19 negative and/or asymptomatic
Who cannot join
- Subject who does not/will not eat animal protein sources.
- Body mass index <20 or >30.
- Hemoglobin <10g/dL at screening.
- Platelets <150,000/uL at screening.
- History of diabetes.
- History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
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- History of gastrointestinal bypass/reduction surgery.
- History of a chronic inflammatory disease (e.g. what?)
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- Currently using prescription blood thinning medications.
- Currently using corticosteroid medications.
- Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
- Unwilling to avoid using protein or amino-acid supplements during participation.
- Subjects who are unwilling to fast overnight.
- Participating in >200 minutes/week of vigorous exercise and/or >4 days/week of resistance training.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults.
Read the detailed description
The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults. Individuals in the TRF pattern will only consume food during a 6-hour eating period and fast for the remaining 18 hours. Individuals in the TRAD pattern will consume isocaloric and isonitrogenous (RDA or 2RDA) diet but consume an all-beef-breakfast. Participants will consume oral stable isotopes to measure muscle protein synthesis (MPS), whole-body muscle protein breakdown (MPB), and whole-body protein balance (WBPB). Appropriate muscle, blood samples, and urine will be collected throughout a 24-hour metabolic trial following a 2-day controlled diet.
- Conditions
- Nutrition Disorders in Old Age
- Being tested
- isocaloric, isonitrogenous meals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isocaloric, isonitrogenous mealsOther
Participants will eat prepared study meals for 3 days that have either the RDA of protein per day or twice the RDA of protein per day.
| Study group | Role | What they receive |
|---|---|---|
| TRF of RDA | Active comparator | A time-restricted model of consumption of the RDA of protein/day. Receives: Other: isocaloric, isonitrogenous meals |
| TRAD of RDA | Active comparator | A typical American dietary ingestion pattern of the RDA of protein/day. Receives: Other: isocaloric, isonitrogenous meals |
| TRF of 2RDA | Experimental | A time-restricted model of consumption of twice the RDA of protein/day. Receives: Other: isocaloric, isonitrogenous meals |
| TRAD of 2RDA | Experimental | A typical American dietary ingestion pattern of twice the RDA of protein/day. Receives: Other: isocaloric, isonitrogenous meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body protein balance
Volume of net protein produced per unit of time
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start29 Mar 2023
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Disorders in Old AgeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Church, Principal investigator, UAMS (University of Arkansas for Medical Sciences)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610644
- Sponsor's protocol ID
- 275081
- Status last verified
- Dec 2024
- First submitted
- 2 Nov 2022
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Time Restricted Feeding on Daily Protein Requirements
- ClinicalTrials.gov ID
- NCT05610644
- Acronym / sponsor ID
- 275081
- Conditions
- Nutrition Disorders in Old Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 9 Nov 2022 (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 aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults.
Detailed description
The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults. Individuals in the TRF pattern will only consume food during a 6-hour eating period and fast for the remaining 18 hours. Individuals in the TRAD pattern will consume isocaloric and isonitrogenous (RDA or 2RDA) diet but consume an all-beef-breakfast. Participants will consume oral stable isotopes to measure muscle protein synthesis (MPS), whole-body muscle protein breakdown (MPB), and whole-body protein balance (WBPB). Appropriate muscle, blood samples, and urine will be collected throughout a 24-hour metabolic trial following a 2-day controlled diet.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TRF of RDA | Active comparator | Other: isocaloric, isonitrogenous mealsA time-restricted model of consumption of the RDA of protein/day. |
| TRAD of RDA | Active comparator | Other: isocaloric, isonitrogenous mealsA typical American dietary ingestion pattern of the RDA of protein/day. |
| TRF of 2RDA | Experimental | Other: isocaloric, isonitrogenous mealsA time-restricted model of consumption of twice the RDA of protein/day. |
| TRAD of 2RDA | Experimental | Other: isocaloric, isonitrogenous mealsA typical American dietary ingestion pattern of twice the RDA of protein/day. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women ages 50-75 years.
- BMI 20-30 kg/m2 inclusive.
- Capable of providing informed consent.
- COVID-19 negative and/or asymptomatic
Key exclusion criteria (15 listed)
- Subject who does not/will not eat animal protein sources.
- Body mass index <20 or >30.
- Hemoglobin <10g/dL at screening.
- Platelets <150,000/uL at screening.
- History of diabetes.
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 |
|---|---|---|
| isocaloric, isonitrogenous mealsParticipants will eat prepared study meals for 3 days that have either the RDA of protein per day or twice the RDA of protein per day. | Other | TRAD of 2RDA, TRAD of RDA, TRF of 2RDA, TRF of RDA |
Primary outcome
Whole-body protein balance
Time frame: 24 hours
Volume of net protein produced per unit of time
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 20 Dec 2024.
- 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.
David Church principal investigator
UAMS (University of Arkansas for Medical Sciences)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isocaloric, isonitrogenous meals in people with Nutrition Disorders in Old Age, run by University of Arkansas 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 4 inclusion and 15 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 20 Dec 2024. 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?
Whole-body protein balance (time frame: 24 hours). 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 20 Dec 2024.