Sarcopenia Clinical Trial
Official title:
The Effect of Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
NCT number | NCT06157385 |
Other study ID # | IRB2023-505 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2023 |
Est. completion date | May 2024 |
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | May 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - <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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University | National Cattlemen's Beef Association |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Primary | Height in Inches | This will be measured using a stadiometer. | This will be assessed at baseline and after the 4-month intervention. | |
Primary | Weight in Pounds | This will be measured using the Tanita MC-780U BIA Scale. | This will be assessed at baseline and after the 4-month intervention. | |
Primary | BMI in (lb/in^2)*703 | This will be calculated with the Tanita MC-780U BIA Scale. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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. | |
Secondary | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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 | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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. | This will be assessed at baseline and after the 4-month intervention. | |
Secondary | 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. | This will be collected throughout the study and assessed after the intervention. |
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