SarcopeniaNCT05593978
Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
A study testing Culinary Medicine in people with Sarcopenia, run by Texas Tech University at 1 site in United States.
Trial summary
Aging is associated with a decline in muscle mass, strength, and physical function, leading to muscle mass loss and weakness. These concerns can impact an individual's functional independence and quality of life (QOL). Dietary protein stimulates muscle protein growth. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Culinary Medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Jan 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years and older
- physically active
- able to cook for oneself
- willing to complete two blood draws
Who cannot join
- <65 years old
- sedentary lifestyle
- bleeding disorder
- heart pacemaker
- type 1 diabetics and type 2 diabetics taking insulin
- current smokers
- amputees
Trial locations and contacts
1 site in 1 country.
About this study
Aging is associated with a decline in muscle mass, strength, and physical function, leading to muscle mass loss and weakness. These concerns can impact an individual's functional independence and quality of life (QOL). Dietary protein stimulates muscle protein growth. Current studies suggest that optimal protein intake for older adults is greater than the Recommended Dietary Allowance. Barriers to consuming protein-rich foods in older adults include reductions in taste and smell, dentition, dexterity, and changes in living situation. Therefore, nutritional interventions are needed to effectively improve eating behaviors, diet quality, and stimulate muscle growth and strength. These interventions will help prevent, manage, and promote muscle mass loss recovery. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Cooking demonstrations, or culinary medicine (CM), can help teach healthy cooking to reduce potential red meat consumption barriers and improve community-dwelling older adults' dietary habits. Thus, CM can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. CM is an evidenced-base field that combines skills of preparing, cooking, and presenting food with the science of medicine. This field can help to accomplish potential eating behaviors and health outcome improvements. A tailored CM program can be an effective strategy that could reduce barriers in protein intake that will enable older adults to age well and productively.
- Conditions
- Sarcopenia
- Being tested
- Culinary Medicine, Control
- Keywords
- Culinary medicine, muscle synthesis, muscle strength, protein intake
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culinary MedicineBehavioural
The CM-group will receive weekly cooking demonstrations and education videos via electronic links for 16 weeks, and three nutrition education based on the content of the Nutrition Care Manual from the Academy of Nutrition and Dietetics to show age-appropriate recipes with correct preparation methods and different cooking methods for lean ground red meat to increase protein consumption.
ControlBehavioural
The CN-group will receive weekly recipes via electronic links without the culinary medicine intervention.
| Study group | Role | What they receive |
|---|---|---|
| Culinary Medicine | Experimental | Those in this group will receive culinary medicine, which includes cooking videos and educational videos to help educate on ways to increase protein intake through lean ground beef. Receives: Behavioral: Culinary Medicine |
| Control | Other | This group will only receive recipes containing lean ground beef to help increase protein intake. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Energy X-ray Absorptiometry (DXA)
DXA will measure full body muscle mass and fat mass in grams.
Measured: Baseline and change from baseline muscle mass and fat mass at 4 months
Secondary outcomes (8)
Protein questionnaire
The subject will fill out an online modified version of the rapid self-administered dietary protein food frequency questionnaire. This questionnaire contains 20-items evaluating the weekly intake of different types of meat, dairy, eggs, beans to provide the weekly protein intake in grams.
Measured: Baseline and through study completion, an average of 4 months
Cooking Effectiveness Questionnaire
Questionnaire to record effectiveness of culinary medicine cooking videos based on a scale of from "completely confident" to "not confident at all"
Measured: Baseline and through study completion, an average of 4 months
Body mass index in kg/m^2
Weight in kg and height in meters will be used to calculate BMI
Measured: Baseline and change from baseline BMI at 4 months
Weight in lbs
Weight will be measure to the nearest 0.1 lbs
Measured: Baseline and change from baseline weight at 4 months
Height in inches
Height will be measured to the nearest 0.1 in using a stadiometer.
Measured: Baseline
Steps
Subjects will be provided a Garmin Vivofit 4 watch to monitor their steps throughout the study
Measured: through study completion, an average of 4 months
Grip strength
Grip strength will be measured by a handheld dynamometer. The subject will be asked to used the handheld dynamometer three times for each to obtain the average of the three test results.
Measured: Baseline and change from baseline grip strength at 4 months
Physical activity questionnaire
Community Healthy Activities Model Program for Seniors (CHAMPS) is 41-items that assess the weekly frequency and duration of various physical activities typically undertaken by older adults. Each question ask how many times a week the participant partake in the activity then ask how many total hours a week the participant did the activity. The frequency per week of all exercise-related activities were calculated by the sum frequency scores/week for each of the activities. The higher the score, the better the outcome
Measured: Baseline and change from baseline CHAMPS at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Jun 2022
- Primary completion4 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593978
- Sponsor's protocol ID
- Muscle Culinary Medicine
- Status last verified
- Aug 2023
- First submitted
- 7 Feb 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salas-Groves E, Alcorn M, Childress A, Galyean S. The Effect of Web-Based Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults: Randomized Controlled Trial. JMIR Form Res. 2024 Feb 13;8:e49322. doi: 10.2196/49322.
PubMed 38349721
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
- ClinicalTrials.gov ID
- NCT05593978
- Acronym / sponsor ID
- Muscle Culinary Medicine
- Conditions
- Sarcopenia
- Keywords
- Culinary medicine, muscle synthesis, muscle strength, protein intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 26 Oct 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.
Aging is associated with a decline in muscle mass, strength, and physical function, leading to muscle mass loss and weakness. These concerns can impact an individual's functional independence and quality of life (QOL). Dietary protein stimulates muscle protein growth. Current studies suggest that optimal protein intake for older adults is greater than the Recommended Dietary Allowance. Barriers to consuming protein-rich foods in older adults include reductions in taste and smell, dentition, dexterity, and changes in living situation. Therefore, nutritional interventions are needed to effectively improve eating behaviors, diet quality, and stimulate muscle growth and strength. These interventions will help prevent, manage, and promote muscle mass loss recovery. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Cooking demonstrations, or culinary medicine (CM), can help teach healthy cooking to reduce potential red meat consumption barriers and improve community-dwelling older adults' dietary habits. Thus, CM can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. CM is an evidenced-base field that combines skills of preparing, cooking, and presenting food with the science of medicine. This field can help to accomplish potential eating behaviors and health outcome improvements. A tailored CM program can be an effective strategy that could reduce barriers in protein intake that will enable older adults to age well and productively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culinary Medicine | Experimental | Behavioral: Culinary MedicineThose in this group will receive culinary medicine, which includes cooking videos and educational videos to help educate on ways to increase protein intake through lean ground beef. |
| Control | Other | Behavioral: ControlThis group will only receive recipes containing lean ground beef to help increase protein intake. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years and older
- physically active
- able to cook for oneself
- willing to complete two blood draws
Key exclusion criteria (7 listed)
- <65 years old
- sedentary lifestyle
- bleeding disorder
- heart pacemaker
- type 1 diabetics and type 2 diabetics taking insulin
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 |
|---|---|---|
| Culinary MedicineThe CM-group will receive weekly cooking demonstrations and education videos via electronic links for 16 weeks, and three nutrition education based on the content of the Nutrition Care Manual from the Academy of Nutrition and Dietetics to show age-appropriate recipes with correct preparation methods and different cooking methods for lean ground red meat to increase protein consumption. | Behavioural | Culinary Medicine |
| ControlThe CN-group will receive weekly recipes via electronic links without the culinary medicine intervention. | Behavioural | Control |
Primary outcome
Dual Energy X-ray Absorptiometry (DXA)
Time frame: Baseline and change from baseline muscle mass and fat mass at 4 months
DXA will measure full body muscle mass and fat mass in grams.
8 secondary outcomes
Protein questionnaire
Time frame: Baseline and through study completion, an average of 4 months
Cooking Effectiveness Questionnaire
Time frame: Baseline and through study completion, an average of 4 months
Body mass index in kg/m^2
Time frame: Baseline and change from baseline BMI at 4 months
Weight in lbs
Time frame: Baseline and change from baseline weight at 4 months
Height in inches
Time frame: Baseline
Steps
Time frame: through study completion, an average of 4 months
Grip strength
Time frame: Baseline and change from baseline grip strength at 4 months
Physical activity questionnaire
Time frame: Baseline and change from baseline CHAMPS at 4 months
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 4 Aug 2023.
- Derived from this study: PubMed 38349721Salas-Groves E, Alcorn M, Childress A, Galyean S. The Effect of Web-Based Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults: Randomized Controlled Trial. JMIR Form Res. 2024 Feb 13;8:e49322. doi: 10.2196/49322.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culinary Medicine in people with Sarcopenia, run by Texas Tech University 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 7 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 4 Aug 2023. 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?
Dual Energy X-ray Absorptiometry (DXA) (time frame: Baseline and change from baseline muscle mass and fat mass at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593978, which also lists 1 linked publication.
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 4 Aug 2023.