SarcopeniaNCT06157385
The Effect of 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 sarcopenia and frailty. This deterioration of muscle and physical capabilities impacts an individual's functional independence and quality of life. Dietary protein stimulates muscle protein synthesis. 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
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2023to 22 Jul 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age and older
- Physically active
- Willing to eat beef
- Able to cook
- Able to use a computer or mobile device
- Willing to undergo two blood draws
Who cannot join
- <65 years of age
- Screening for sarcopenia SARC-F score of 4 or greater
- Regular consumption of nicotine, excessive alcohol (4+ drinks/day for women or 5+ drinks/day for men), and/or illicit drugs such as amphetamines, cocaine, marijuana, or opiates
- Have cancer, transplant, amputation, or renal disorder
- Limited mobility
- Self-reported cognitive dysfunction
- Have heart pacemaker
- Have Type 1 diabetes or Type 2 diabetes with insulin therapy
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 sarcopenia and frailty. This deterioration of muscle and physical capabilities impacts an individual's functional independence and quality of life. Dietary protein stimulates muscle protein synthesis. Therefore, nutritional interventions that recommend higher protein intakes may enhance muscle protein synthesis. Food intake, including protein-rich foods such as red meat, has been shown to decline with age. Barriers to consuming protein-rich foods include reductions in taste and smell, dentition and dexterity, and changes in living situations. Therefore, nutritional interventions that can effectively improve eating behaviors and diet quality while stimulating muscle protein synthesis in older adults are necessary to help prevent, manage, and promote recovery of sarcopenia. To reduce potential barriers of red meat consumption in community-dwelling older adults, an additional beneficial strategy may be the use of cooking demonstrations, or culinary medicine, by imparting knowledge about healthy cooking to improve the dietary habits of individuals who are at risk of sarcopenia. In this approach, people will be educated about age-appropriate, healthy eating behaviors and equipped with basic cooking skills to incorporate nutritious food into their daily diet. A systematic review concluded that culinary interventions such as cooking classes effectively improved attitudes, self-efficacy, and healthy eating in children and adults. A recent study using cooking videos to encourage the consumption of calcium-rich foods showed that the subjects gained knowledge and were motivated to consume calcium-rich foods, and video demonstrations were accepted as an effective communication channel to impart cooking skills. Additionally, it is suggested that cooking at home improves adherence to healthy nutrition, thereby reducing chronic illness risks. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Thus, cooking demonstrations can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. Culinary medicine is an evidence-based field that combines skills of preparing, cooking, and presenting food with the science of medicine to accomplish potential improvements in eating behaviors and health outcomes. The goal of culinary medicine is to help people improve their diet quality which assists them in their medical regimen to produce an effective treatment.
- Conditions
- Sarcopenia
- Being tested
- Culinary Medicine, Control
- Keywords
- Culinary medicine, Protein intake, Muscle quality, Older adults
- 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
Also called CM
The CM group will receive virtually-delivered cooking demonstration videos every week and nutrition education videos every other week. The cooking demonstrations will provide them with visual instructions on how to incorporate lean beef into their diet. The nutrition education videos will be developed using the Nutrition Care Manual from the Academy of Nutrition and Dietetics and will cover the importance of maintaining adequate protein intake and ways to enhance it in the diet.
ControlBehavioural
Also called CN
The CN group will receive virtually-delivered recipes every week centered on lean beef intake.
| Study group | Role | What they receive |
|---|---|---|
| Culinary Medicine | Experimental | The participants in this group will receive culinary medicine in the form of videos that will include cooking demonstrations and nutrition education based on lean beef to enhance protein intake. Receives: Behavioral: Culinary Medicine |
| Control | Other | This group will only receive recipes based on lean beef to enhance protein intake. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Frequency Questionnaire (FFQ)
The Diet History Questionnaire III (DHQ III) is a comprehensive FFQ that will be used to measure the subjects' protein intake and healthy eating index (HEI) for diet quality. The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
Measured: This will be assessed at baseline and after the 4-month intervention.
Weekly Cooking Effectiveness and Protein Intake Questionnaire
This is a brief weekly questionnaire designed by the research team to assess the subjects' protein intake as well as their experience with the beef and culinary medicine or recipes that received for that week. There is no scale associated with this measurement. The researchers will evaluate the answers individually.
Measured: This will be assessed every week throughout the 4-month intervention starting at the end of the first week.
Secondary outcomes (13)
Cooking Effectiveness Questionnaire
This detailed questionnaire designed by the research team will assess the subjects' confidence, attitudes, and any possible barriers around cooking for themselves. There is no scale associated with this measurement. The researchers will evaluate the answers individually.
Measured: This will be assessed at baseline and after the 4-month intervention.
Nutrition Knowledge Questionnaire
This questionnaire designed by the research team will assess the subjects' understanding of the nutritional qualities of red meat and other protein sources. This information will be used to gauge the effectiveness of the nutrition education provided. There is no scale associated with this measurement. The researchers will evaluate the answers individually.
Measured: This will be assessed at baseline and after the 4-month intervention.
Physical Activity Questionnaire
The Physical Activity Scale for the Elderly (PASE) is a validated questionnaire for older adults that will be used to assess the physical activity rates of the subjects. There is no scale associated with this measurement. The researchers will evaluate the answers individually.
Measured: This will be assessed at baseline and after the 4-month intervention.
Handgrip Strength
A handgrip dynamometer will be used to assess the muscle strength of the subjects. Their grip strengths will be measured three times with each hand, so an average of those three measurements can be calculated.
Measured: This will be assessed at baseline and after the 4-month intervention.
Short Physical Performance Battery (SPPB) Exam
This is a validated test proctored by a member of the research team that consists of a series of exercises to assess the muscle function of the subjects. The scale is a minimum of 0 and maximum of 12 points overall.
Measured: This will be assessed at baseline and after the 4-month intervention.
Serum Value of Vitamin B12 in pg/mL
A blood draw will be completed by a professional phlebotomist, and the sample collected will be analyzed to measure serum levels of vitamin B12. This nutrient is used in the process of muscle protein synthesis in the body and will be indicator of this process in the subjects.
Measured: This will be assessed at baseline and after the 4-month intervention.
Serum Value of Folate in ng/mL
A blood draw will be completed by a professional phlebotomist, and the sample collected will be analyzed to measure serum levels of folate. This nutrient is used in the process of muscle protein synthesis in the body and will be indicator of this process in the subjects.
Measured: This will be assessed at baseline and after the 4-month intervention.
Serum Value of Creatinine in mg/dL
A blood draw will be completed by a professional phlebotomist, and the sample collected will be analyzed to measure serum levels of creatinine. This nutrient is used in the process of muscle protein synthesis in the body and will be indicator of this process in the subjects.
Measured: This will be assessed at baseline and after the 4-month intervention.
Daily Steps
The subjects will be given a physical activity watch, the Garmin Vivofit 4, and instructed to wear it throughout each day for the duration of the study. This watch will collect the daily steps throughout the study and will be used to further assess physical activity rates of the subjects.
Measured: This will be collected throughout the study and assessed after the intervention.
BMI in (lb/in^2)*703
This will be calculated with the Tanita MC-780U BIA Scale.
Measured: This will be assessed at baseline and after the 4-month intervention.
Weight in Pounds
This will be measured using the Tanita MC-780U BIA Scale.
Measured: This will be assessed at baseline and after the 4-month intervention.
Height in Inches
This will be measured using a stadiometer.
Measured: This will be assessed at baseline and after the 4-month intervention.
Muscle Composition with Bioelectric Impedance Analysis (BIA) Tanita MC-780U Scale
This will assess the muscle mass which will give an indication of muscle composition.
Measured: This will be assessed at baseline and after the 4-month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start6 May 2023
- Primary completion25 Apr 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Sponsor
- Investigators
- Shannon Galyean, Principal investigator, Texas Tech Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157385
- Sponsor's protocol ID
- IRB2023-505
- Status last verified
- Jul 2024
- First submitted
- 26 Oct 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Porter Starr KN, Orenduff M, McDonald SR, Mulder H, Sloane R, Pieper CF, Bales CW. Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Jan-Mar;38(1):33-49. doi: 10.1080/21551197.2018.1564200. Epub 2019 Feb 27.
PubMed 30810500Hengeveld LM, Boer JMA, Gaudreau P, Heymans MW, Jagger C, Mendonca N, Ocke MC, Presse N, Sette S, Simonsick EM, Tapanainen H, Turrini A, Virtanen SM, Wijnhoven HAH, Visser M. Prevalence of protein intake below recommended in community-dwelling older adults: a meta-analysis across cohorts from the PROMISS consortium. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1212-1222. doi: 10.1002/jcsm.12580. Epub 2020 Jun 16.
PubMed 32548960Viitasalo JT, Era P, Leskinen AL, Heikkinen E. Muscular strength profiles and anthropometry in random samples of men aged 31-35, 51-55 and 71-75 years. Ergonomics. 1985;28(11):1563-74.
Avlund K, Schroll M, Davidsen M, Løvborg B, Rantanen T. Maximal isometric muscle strength and functional ability in daily activities among 75-year-old men and women. Scandinavian Journal of Medicine & Science in Sports. 1994;4(1):32-40.
Genaro Pde S, Martini LA. Effect of protein intake on bone and muscle mass in the elderly. Nutr Rev. 2010 Oct;68(10):616-23. doi: 10.1111/j.1753-4887.2010.00321.x.
PubMed 20883419Franzke B, Neubauer O, Cameron-Smith D, Wagner KH. Dietary Protein, Muscle and Physical Function in the Very Old. Nutrients. 2018 Jul 20;10(7):935. doi: 10.3390/nu10070935.
PubMed 30037048Ni Lochlainn M, Bowyer RCE, Steves CJ. Dietary Protein and Muscle in Aging People: The Potential Role of the Gut Microbiome. Nutrients. 2018 Jul 20;10(7):929. doi: 10.3390/nu10070929.
PubMed 30036990Cholewa JM, Dardevet D, Lima-Soares F, de Araujo Pessoa K, Oliveira PH, Dos Santos Pinho JR, Nicastro H, Xia Z, Cabido CE, Zanchi NE. Dietary proteins and amino acids in the control of the muscle mass during immobilization and aging: role of the MPS response. Amino Acids. 2017 May;49(5):811-820. doi: 10.1007/s00726-017-2390-9. Epub 2017 Feb 7.
PubMed 28175999Jyvakorpi SK, Pitkala KH, Puranen TM, Bjorkman MP, Kautiainen H, Strandberg TE, Soini H, Suominen MH. Low protein and micronutrient intakes in heterogeneous older population samples. Arch Gerontol Geriatr. 2015 Nov-Dec;61(3):464-71. doi: 10.1016/j.archger.2015.06.022. Epub 2015 Jul 15.
PubMed 26298429Berner LA, Becker G, Wise M, Doi J. Characterization of dietary protein among older adults in the United States: amount, animal sources, and meal patterns. J Acad Nutr Diet. 2013 Jun;113(6):809-15. doi: 10.1016/j.jand.2013.01.014. Epub 2013 Mar 13.
PubMed 23491327Fulgoni VL 3rd. Current protein intake in America: analysis of the National Health and Nutrition Examination Survey, 2003-2004. Am J Clin Nutr. 2008 May;87(5):1554S-1557S. doi: 10.1093/ajcn/87.5.1554S.
PubMed 18469286Appleton KM. Barriers to and Facilitators of the Consumption of Animal-Based Protein-Rich Foods in Older Adults. Nutrients. 2016 Mar 29;8(4):187. doi: 10.3390/nu8040187.
PubMed 27043615LeBlanc-Morales N. Culinary Medicine: Patient Education for Therapeutic Lifestyle Changes. Crit Care Nurs Clin North Am. 2019 Mar;31(1):109-123. doi: 10.1016/j.cnc.2018.11.009. Epub 2018 Dec 24.
PubMed 30736931La Puma J. What Is Culinary Medicine and What Does It Do? Popul Health Manag. 2016 Feb;19(1):1-3. doi: 10.1089/pop.2015.0003. Epub 2015 Jun 2. No abstract available.
PubMed 26035069Hasan B, Thompson WG, Almasri J, Wang Z, Lakis S, Prokop LJ, Hensrud DD, Frie KS, Wirtz MJ, Murad AL, Ewoldt JS, Murad MH. The effect of culinary interventions (cooking classes) on dietary intake and behavioral change: a systematic review and evidence map. BMC Nutr. 2019 May 10;5:29. doi: 10.1186/s40795-019-0293-8. eCollection 2019.
PubMed 32153942
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
- ClinicalTrials.gov ID
- NCT06157385
- Acronym / sponsor ID
- IRB2023-505
- Conditions
- Sarcopenia
- Keywords
- Culinary medicine, Protein intake, Muscle quality, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- 6 May 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 5 Dec 2023 (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 sarcopenia and frailty. This deterioration of muscle and physical capabilities impacts an individual's functional independence and quality of life. Dietary protein stimulates muscle protein synthesis. Therefore, nutritional interventions that recommend higher protein intakes may enhance muscle protein synthesis. Food intake, including protein-rich foods such as red meat, has been shown to decline with age. Barriers to consuming protein-rich foods include reductions in taste and smell, dentition and dexterity, and changes in living situations. Therefore, nutritional interventions that can effectively improve eating behaviors and diet quality while stimulating muscle protein synthesis in older adults are necessary to help prevent, manage, and promote recovery of sarcopenia. To reduce potential barriers of red meat consumption in community-dwelling older adults, an additional beneficial strategy may be the use of cooking demonstrations, or culinary medicine, by imparting knowledge about healthy cooking to improve the dietary habits of individuals who are at risk of sarcopenia. In this approach, people will be educated about age-appropriate, healthy eating behaviors and equipped with basic cooking skills to incorporate nutritious food into their daily diet. A systematic review concluded that culinary interventions such as cooking classes effectively improved attitudes, self-efficacy, and healthy eating in children and adults. A recent study using cooking videos to encourage the consumption of calcium-rich foods showed that the subjects gained knowledge and were motivated to consume calcium-rich foods, and video demonstrations were accepted as an effective communication channel to impart cooking skills. Additionally, it is suggested that cooking at home improves adherence to healthy nutrition, thereby reducing chronic illness risks. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Thus, cooking demonstrations can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. Culinary medicine is an evidence-based field that combines skills of preparing, cooking, and presenting food with the science of medicine to accomplish potential improvements in eating behaviors and health outcomes. The goal of culinary medicine is to help people improve their diet quality which assists them in their medical regimen to produce an effective treatment.
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 MedicineThe participants in this group will receive culinary medicine in the form of videos that will include cooking demonstrations and nutrition education based on lean beef to enhance protein intake. |
| Control | Other | Behavioral: ControlThis group will only receive recipes based on lean beef to enhance protein intake. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 65 years of age and older
- Physically active
- Willing to eat beef
- Able to cook
- Able to use a computer or mobile device
Key exclusion criteria (8 listed)
- <65 years of age
- Screening for sarcopenia SARC-F score of 4 or greater
- Regular consumption of nicotine, excessive alcohol (4+ drinks/day for women or 5+ drinks/day for men), and/or illicit drugs such as amphetamines, cocaine, marijuana, or opiates
- Have cancer, transplant, amputation, or renal disorder
- Limited mobility
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 MedicineAlso: CMThe CM group will receive virtually-delivered cooking demonstration videos every week and nutrition education videos every other week. The cooking demonstrations will provide them with visual instructions on how to incorporate lean beef into their diet. The nutrition education videos will be developed using the Nutrition Care Manual from the Academy of Nutrition and Dietetics and will cover the importance of maintaining adequate protein intake and ways to enhance it in the diet. | Behavioural | Culinary Medicine |
| ControlAlso: CNThe CN group will receive virtually-delivered recipes every week centered on lean beef intake. | Behavioural | Control |
Primary outcome
Food Frequency Questionnaire (FFQ)
Time frame: This will be assessed at baseline and after the 4-month intervention.
The Diet History Questionnaire III (DHQ III) is a comprehensive FFQ that will be used to measure the subjects' protein intake and healthy eating index (HEI) for diet quality. The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
Weekly Cooking Effectiveness and Protein Intake Questionnaire
Time frame: This will be assessed every week throughout the 4-month intervention starting at the end of the first week.
This is a brief weekly questionnaire designed by the research team to assess the subjects' protein intake as well as their experience with the beef and culinary medicine or recipes that received for that week. There is no scale associated with this measurement. The researchers will evaluate the answers individually.
13 secondary outcomes
Cooking Effectiveness Questionnaire
Time frame: This will be assessed at baseline and after the 4-month intervention.
Nutrition Knowledge Questionnaire
Time frame: This will be assessed at baseline and after the 4-month intervention.
Physical Activity Questionnaire
Time frame: This will be assessed at baseline and after the 4-month intervention.
Handgrip Strength
Time frame: This will be assessed at baseline and after the 4-month intervention.
Short Physical Performance Battery (SPPB) Exam
Time frame: This will be assessed at baseline and after the 4-month intervention.
Serum Value of Vitamin B12 in pg/mL
Time frame: This will be assessed at baseline and after the 4-month intervention.
Serum Value of Folate in ng/mL
Time frame: This will be assessed at baseline and after the 4-month intervention.
Serum Value of Creatinine in mg/dL
Time frame: This will be assessed at baseline and after the 4-month intervention.
Daily Steps
Time frame: This will be collected throughout the study and assessed after the intervention.
BMI in (lb/in^2)*703
Time frame: This will be assessed at baseline and after the 4-month intervention.
Weight in Pounds
Time frame: This will be assessed at baseline and after the 4-month intervention.
Height in Inches
Time frame: This will be assessed at baseline and after the 4-month intervention.
Muscle Composition with Bioelectric Impedance Analysis (BIA) Tanita MC-780U Scale
Time frame: This will be assessed at baseline and after the 4-month intervention.
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 25 Jul 2024.
- Background: PubMed 30810500Porter Starr KN, Orenduff M, McDonald SR, Mulder H, Sloane R, Pieper CF, Bales CW. Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Jan-Mar;38(1):33-49. doi: 10.1080/21551197.2018.1564200. Epub 2019 Feb 27.
- Background: PubMed 32548960Hengeveld LM, Boer JMA, Gaudreau P, Heymans MW, Jagger C, Mendonca N, Ocke MC, Presse N, Sette S, Simonsick EM, Tapanainen H, Turrini A, Virtanen SM, Wijnhoven HAH, Visser M. Prevalence of protein intake below recommended in community-dwelling older adults: a meta-analysis across cohorts from the PROMISS consortium. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1212-1222. doi: 10.1002/jcsm.12580. Epub 2020 Jun 16.
- BackgroundViitasalo JT, Era P, Leskinen AL, Heikkinen E. Muscular strength profiles and anthropometry in random samples of men aged 31-35, 51-55 and 71-75 years. Ergonomics. 1985;28(11):1563-74.
- BackgroundAvlund K, Schroll M, Davidsen M, Løvborg B, Rantanen T. Maximal isometric muscle strength and functional ability in daily activities among 75-year-old men and women. Scandinavian Journal of Medicine & Science in Sports. 1994;4(1):32-40.
- Background: PubMed 20883419Genaro Pde S, Martini LA. Effect of protein intake on bone and muscle mass in the elderly. Nutr Rev. 2010 Oct;68(10):616-23. doi: 10.1111/j.1753-4887.2010.00321.x.
- Background: PubMed 30037048Franzke B, Neubauer O, Cameron-Smith D, Wagner KH. Dietary Protein, Muscle and Physical Function in the Very Old. Nutrients. 2018 Jul 20;10(7):935. doi: 10.3390/nu10070935.
- Background: PubMed 30036990Ni Lochlainn M, Bowyer RCE, Steves CJ. Dietary Protein and Muscle in Aging People: The Potential Role of the Gut Microbiome. Nutrients. 2018 Jul 20;10(7):929. doi: 10.3390/nu10070929.
- Background: PubMed 28175999Cholewa JM, Dardevet D, Lima-Soares F, de Araujo Pessoa K, Oliveira PH, Dos Santos Pinho JR, Nicastro H, Xia Z, Cabido CE, Zanchi NE. Dietary proteins and amino acids in the control of the muscle mass during immobilization and aging: role of the MPS response. Amino Acids. 2017 May;49(5):811-820. doi: 10.1007/s00726-017-2390-9. Epub 2017 Feb 7.
- Background: PubMed 26298429Jyvakorpi SK, Pitkala KH, Puranen TM, Bjorkman MP, Kautiainen H, Strandberg TE, Soini H, Suominen MH. Low protein and micronutrient intakes in heterogeneous older population samples. Arch Gerontol Geriatr. 2015 Nov-Dec;61(3):464-71. doi: 10.1016/j.archger.2015.06.022. Epub 2015 Jul 15.
- Background: PubMed 23491327Berner LA, Becker G, Wise M, Doi J. Characterization of dietary protein among older adults in the United States: amount, animal sources, and meal patterns. J Acad Nutr Diet. 2013 Jun;113(6):809-15. doi: 10.1016/j.jand.2013.01.014. Epub 2013 Mar 13.
- Background: PubMed 18469286Fulgoni VL 3rd. Current protein intake in America: analysis of the National Health and Nutrition Examination Survey, 2003-2004. Am J Clin Nutr. 2008 May;87(5):1554S-1557S. doi: 10.1093/ajcn/87.5.1554S.
- Background: PubMed 27043615Appleton KM. Barriers to and Facilitators of the Consumption of Animal-Based Protein-Rich Foods in Older Adults. Nutrients. 2016 Mar 29;8(4):187. doi: 10.3390/nu8040187.
- 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.
Shannon Galyean principal investigator
Texas Tech Nutritional 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 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 6 inclusion and 8 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 25 Jul 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?
Food Frequency Questionnaire (FFQ) (time frame: This will be assessed at baseline and after the 4-month intervention.). 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?
On the ClinicalTrials.gov record for NCT06157385, which also lists 25 linked publications.
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 25 Jul 2024.