- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05593978
Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
August 2, 2023 updated by: Texas Tech University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79409
- Texas Tech University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Culinary Medicine
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.
|
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.
|
|
Other: Control
This group will only receive recipes containing lean ground beef to help increase protein intake.
|
The CN-group will receive weekly recipes via electronic links without the culinary medicine intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and change from baseline muscle mass and fat mass at 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Protein questionnaire
Time Frame: Baseline and through study completion, an average of 4 months
|
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.
|
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
|
Questionnaire to record effectiveness of culinary medicine cooking videos based on a scale of from "completely confident" to "not confident at all"
|
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 kg and height in meters will be used to calculate BMI
|
Baseline and change from baseline BMI at 4 months
|
|
Weight in lbs
Time Frame: Baseline and change from baseline weight at 4 months
|
Weight will be measure to the nearest 0.1 lbs
|
Baseline and change from baseline weight at 4 months
|
|
Height in inches
Time Frame: Baseline
|
Height will be measured to the nearest 0.1 in using a stadiometer.
|
Baseline
|
|
Steps
Time Frame: through study completion, an average of 4 months
|
Subjects will be provided a Garmin Vivofit 4 watch to monitor their steps throughout the study
|
through study completion, an average of 4 months
|
|
Grip strength
Time Frame: Baseline and change from baseline grip strength at 4 months
|
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.
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Baseline and change from baseline grip strength at 4 months
|
|
Physical activity questionnaire
Time Frame: Baseline and change from baseline CHAMPS at 4 months
|
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
|
Baseline and change from baseline CHAMPS at 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
December 4, 2022
Study Completion (Actual)
January 31, 2023
Study Registration Dates
First Submitted
February 7, 2022
First Submitted That Met QC Criteria
October 21, 2022
First Posted (Actual)
October 26, 2022
Study Record Updates
Last Update Posted (Actual)
August 4, 2023
Last Update Submitted That Met QC Criteria
August 2, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Muscle Culinary Medicine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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