NCT06157385

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

October 26, 2023

Last Update Submit

July 24, 2024

Conditions

Keywords

Culinary medicineProtein intakeMuscle qualityOlder adults

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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 will be assessed at baseline and after the 4-month intervention.

  • Nutrition Knowledge Questionnaire

    This will be assessed at baseline and after the 4-month intervention.

  • Physical Activity Questionnaire

    This will be assessed at baseline and after the 4-month intervention.

  • Handgrip Strength

    This will be assessed at baseline and after the 4-month intervention.

  • Short Physical Performance Battery (SPPB) Exam

    This will be assessed at baseline and after the 4-month intervention.

  • +8 more secondary outcomes

Study Arms (2)

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.

Behavioral: Culinary Medicine

Control

OTHER

This group will only receive recipes based on lean beef to enhance protein intake.

Behavioral: Control

Interventions

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.

Also known as: CM
Culinary Medicine
ControlBEHAVIORAL

The CN group will receive virtually-delivered recipes every week centered on lean beef intake.

Also known as: CN
Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

Related Publications (25)

  • 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.

    PMID: 30810500BACKGROUND
  • Hengeveld 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.

    PMID: 32548960BACKGROUND
  • Viitasalo 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20883419BACKGROUND
  • Franzke 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.

    PMID: 30037048BACKGROUND
  • Ni 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.

    PMID: 30036990BACKGROUND
  • Cholewa 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.

    PMID: 28175999BACKGROUND
  • Jyvakorpi 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.

    PMID: 26298429BACKGROUND
  • Berner 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.

    PMID: 23491327BACKGROUND
  • Fulgoni 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.

    PMID: 18469286BACKGROUND
  • Appleton 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.

    PMID: 27043615BACKGROUND
  • LeBlanc-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.

    PMID: 30736931BACKGROUND
  • La 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.

    PMID: 26035069BACKGROUND
  • Hasan 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.

    PMID: 32153942BACKGROUND
  • Bramston V, Rouf A, Allman-Farinelli M. The Development of Cooking Videos to Encourage Calcium Intake in Young Adults. Nutrients. 2020 Apr 27;12(5):1236. doi: 10.3390/nu12051236.

    PMID: 32349354BACKGROUND
  • Polak R, Tirosh A, Livingston B, Pober D, Eubanks JE Jr, Silver JK, Minezaki K, Loten R, Phillips EM. Preventing Type 2 Diabetes with Home Cooking: Current Evidence and Future Potential. Curr Diab Rep. 2018 Sep 14;18(10):99. doi: 10.1007/s11892-018-1061-x.

    PMID: 30218282BACKGROUND
  • Wolfson JA, Leung CW, Richardson CR. More frequent cooking at home is associated with higher Healthy Eating Index-2015 score. Public Health Nutr. 2020 Sep;23(13):2384-2394. doi: 10.1017/S1368980019003549. Epub 2020 Jan 10.

    PMID: 31918785BACKGROUND
  • Irl B H, Evert A, Fleming A, Gaudiani LM, Guggenmos KJ, Kaufer DI, McGill JB, Verderese CA, Martinez J. Culinary Medicine: Advancing a Framework for Healthier Eating to Improve Chronic Disease Management and Prevention. Clin Ther. 2019 Oct;41(10):2184-2198. doi: 10.1016/j.clinthera.2019.08.009. Epub 2019 Sep 20.

    PMID: 31543284BACKGROUND
  • Zivkovic AM, German JB. Metabolomics for assessment of nutritional status. Curr Opin Clin Nutr Metab Care. 2009 Sep;12(5):501-7. doi: 10.1097/MCO.0b013e32832f1916.

    PMID: 19584717BACKGROUND
  • Santarpia L, Contaldo F, Pasanisi F. Dietary protein content for an optimal diet: a clinical view. J Cachexia Sarcopenia Muscle. 2017 Jun;8(3):345-348. doi: 10.1002/jcsm.12176. Epub 2017 Apr 25.

    PMID: 28444858BACKGROUND
  • Micha R, Michas G, Mozaffarian D. Unprocessed red and processed meats and risk of coronary artery disease and type 2 diabetes--an updated review of the evidence. Curr Atheroscler Rep. 2012 Dec;14(6):515-24. doi: 10.1007/s11883-012-0282-8.

    PMID: 23001745BACKGROUND
  • Micha R, Wallace SK, Mozaffarian D. Red and processed meat consumption and risk of incident coronary heart disease, stroke, and diabetes mellitus: a systematic review and meta-analysis. Circulation. 2010 Jun 1;121(21):2271-83. doi: 10.1161/CIRCULATIONAHA.109.924977. Epub 2010 May 17.

    PMID: 20479151BACKGROUND
  • O'Connor LE, Paddon-Jones D, Wright AJ, Campbell WW. A Mediterranean-style eating pattern with lean, unprocessed red meat has cardiometabolic benefits for adults who are overweight or obese in a randomized, crossover, controlled feeding trial. Am J Clin Nutr. 2018 Jul 1;108(1):33-40. doi: 10.1093/ajcn/nqy075.

    PMID: 29901710BACKGROUND
  • Gilmore LA, Walzem RL, Crouse SF, Smith DR, Adams TH, Vaidyanathan V, Cao X, Smith SB. Consumption of high-oleic acid ground beef increases HDL-cholesterol concentration but both high- and low-oleic acid ground beef decrease HDL particle diameter in normocholesterolemic men. J Nutr. 2011 Jun;141(6):1188-94. doi: 10.3945/jn.110.136085. Epub 2011 Apr 27.

    PMID: 21525253BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Shannon Galyean

    Texas Tech Nutritional Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

December 5, 2023

Study Start

May 6, 2023

Primary Completion

April 25, 2024

Study Completion

July 22, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations