NCT05593978

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

February 7, 2022

Last Update Submit

August 2, 2023

Conditions

Keywords

Culinary medicinemuscle synthesismuscle strengthprotein intake

Outcome Measures

Primary Outcomes (1)

  • Dual Energy X-ray Absorptiometry (DXA)

    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 Outcomes (8)

  • Protein questionnaire

    Baseline and through study completion, an average of 4 months

  • Cooking Effectiveness Questionnaire

    Baseline and through study completion, an average of 4 months

  • Body mass index in kg/m^2

    Baseline and change from baseline BMI at 4 months

  • Weight in lbs

    Baseline and change from baseline weight at 4 months

  • Height in inches

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Culinary Medicine

EXPERIMENTAL

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.

Behavioral: Culinary Medicine

Control

OTHER

This group will only receive recipes containing lean ground beef to help increase protein intake.

Behavioral: Control

Interventions

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.

Culinary Medicine
ControlBEHAVIORAL

The CN-group will receive weekly recipes via electronic links without the culinary medicine intervention.

Control

Eligibility Criteria

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

You may qualify if:

  • years and older
  • physically active
  • able to cook for oneself
  • willing to complete two blood draws

You may not qualify if:

  • \<65 years old
  • sedentary lifestyle
  • bleeding disorder
  • heart pacemaker
  • type 1 diabetics and type 2 diabetics taking insulin
  • current smokers
  • amputees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

Related Publications (1)

  • Salas-Groves E, Alcorn M, Childress A, Galyean S. The Effect of Web-Based Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults: Randomized Controlled Trial. JMIR Form Res. 2024 Feb 13;8:e49322. doi: 10.2196/49322.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

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

February 7, 2022

First Posted

October 26, 2022

Study Start

June 1, 2022

Primary Completion

December 4, 2022

Study Completion

January 31, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations