Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culinary Medicine
Control
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring Culinary medicine, muscle synthesis, muscle strength, protein intake
Eligibility Criteria
Inclusion Criteria:
- 65 years and older
- physically active
- able to cook for oneself
- willing to complete two blood draws
Exclusion Criteria:
- <65 years old
- sedentary lifestyle
- bleeding disorder
- heart pacemaker
- type 1 diabetics and type 2 diabetics taking insulin
- current smokers
- amputees
Sites / Locations
- Texas Tech University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Culinary Medicine
Control
Arm Description
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.
This group will only receive recipes containing lean ground beef to help increase protein intake.
Outcomes
Primary Outcome Measures
Dual Energy X-ray Absorptiometry (DXA)
DXA will measure full body muscle mass and fat mass in grams.
Secondary Outcome Measures
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.
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"
Body mass index in kg/m^2
Weight in kg and height in meters will be used to calculate BMI
Weight in lbs
Weight will be measure to the nearest 0.1 lbs
Height in inches
Height will be measured to the nearest 0.1 in using a stadiometer.
Steps
Subjects will be provided a Garmin Vivofit 4 watch to monitor their steps throughout the study
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05593978
Brief Title
Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
Official Title
Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 4, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Culinary medicine, muscle synthesis, muscle strength, protein intake
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Culinary Medicine
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
This group will only receive recipes containing lean ground beef to help increase protein intake.
Intervention Type
Behavioral
Intervention Name(s)
Culinary Medicine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
The CN-group will receive weekly recipes via electronic links without the culinary medicine intervention.
Primary Outcome Measure Information:
Title
Dual Energy X-ray Absorptiometry (DXA)
Description
DXA will measure full body muscle mass and fat mass in grams.
Time Frame
Baseline and change from baseline muscle mass and fat mass at 4 months
Secondary Outcome Measure Information:
Title
Protein questionnaire
Description
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.
Time Frame
Baseline and through study completion, an average of 4 months
Title
Cooking Effectiveness Questionnaire
Description
Questionnaire to record effectiveness of culinary medicine cooking videos based on a scale of from "completely confident" to "not confident at all"
Time Frame
Baseline and through study completion, an average of 4 months
Title
Body mass index in kg/m^2
Description
Weight in kg and height in meters will be used to calculate BMI
Time Frame
Baseline and change from baseline BMI at 4 months
Title
Weight in lbs
Description
Weight will be measure to the nearest 0.1 lbs
Time Frame
Baseline and change from baseline weight at 4 months
Title
Height in inches
Description
Height will be measured to the nearest 0.1 in using a stadiometer.
Time Frame
Baseline
Title
Steps
Description
Subjects will be provided a Garmin Vivofit 4 watch to monitor their steps throughout the study
Time Frame
through study completion, an average of 4 months
Title
Grip strength
Description
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.
Time Frame
Baseline and change from baseline grip strength at 4 months
Title
Physical activity questionnaire
Description
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
Time Frame
Baseline and change from baseline CHAMPS at 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
65 years and older
physically active
able to cook for oneself
willing to complete two blood draws
Exclusion Criteria:
<65 years old
sedentary lifestyle
bleeding disorder
heart pacemaker
type 1 diabetics and type 2 diabetics taking insulin
current smokers
amputees
Facility Information:
Facility Name
Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
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