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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05591612
Other study ID # 2022-396
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date May 1, 2023

Study information

Verified date October 2022
Source Texas Tech University
Contact Shannon Galyean, PhD
Phone (806)834-2286
Email shannon.galyean@ttu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Food Intake Study: This will be a 4-week randomized controlled intervention study with a vegetable intake questionnaire, daily food intake, and seasoning usage measurement to test the acceptability of different seasoning ingredients and vegetable intake in healthy adults. Participants will be randomly assigned to one of three groups (a) vegetables prepared with MSG to replace some of the NaCl content (MSG group); (b) vegetables prepared with only NaCl (NaCl group); (c) vegetables prepared with potassium chloride to replace some of the NaCl content (KCl group). Sensory Evaluation Study: A sensory evaluation utilizing all seasoning methods from the intervention will be conducted at a Texas Tech University culinary education lab. In a Texas Tech University culinary education lab, 2-4 vegetables will be cooked and seasoned with either MSG, NaCl, or KCI for taste testing. Then, using a standardized form, participants will rate their acceptability and preference of each vegetable, including sensory characteristics such as appearance, color, odor, texture, and flavor.


Description:

Food Intake Study: This will be a 4-week randomized controlled intervention study with a vegetable intake questionnaire, daily food intake, and seasoning usage measurement to test the acceptability of different seasoning ingredients and vegetable intake in healthy adults. Participants will be randomly assigned to one of three groups (a) vegetables prepared with MSG to replace some of the NaCl content (MSG group); (b) vegetables prepared with only NaCl (NaCl group); (c) vegetables prepared with potassium chloride to replace some of the NaCl content (KCl group). Before the intervention, each group will be asked to keep a daily food intake record for one week to determine baseline vegetable intake. Each group will receive a culinary medicine program electronically, including recipe demonstrations, cooking skills, and nutrition education videos to provide instruction for vegetable consumption according to the Dietary Guidelines for Americans. According to each treatment group, a bottle of seasoning ingredients will be provided to use on vegetables. Prior to the intervention, participants will be 1) instructed on how to track daily food intake data using the MyFitnessPal® app, 2) track food intake for seven days, and 3) complete a questionnaire regarding vegetable intake pre-intervention. According to the group assignment, each treatment group will also receive a bottle of a seasoning blend that includes either MSG, NaCl, or KCl to use on vegetables prepared at home. According to the Dietary Guidelines for Americans, culinary medicine education (recipe demonstrations, cooking skills, and education videos for vegetable consumption) will be delivered electronically at baseline and once per week for four weeks to each participant. For four weeks, participants will track all meals daily, including vegetables prepared with designated seasoning at home. Remote follow-ups and dietary intake will be conducted weekly. After the intervention, the participants will 1) complete the same vegetable intake questionnaire for the four weeks of the intervention and 2) return the bottle of seasoning blend provided. Usage of seasoning for four weeks will be recorded. Data analyses will evaluate the changes in outcomes within and between groups. Participants will also be informed of the sensory evaluation study to be included among other participants of that study. MSG_Diet Food Questionaries (Updated).docx MyFitness Pal instructions.docx Sensory Evaluation Study: A sensory evaluation utilizing all seasoning methods from the intervention will be conducted at a Texas Tech University culinary education lab. In a Texas Tech University culinary education lab, 2-4 vegetables will be cooked and seasoned with either MSG, NaCl, or KCI for taste testing. Then, using a standardized form, participants will rate their acceptability and preference of each vegetable, including sensory characteristics such as appearance, color, odor, texture, and flavor.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 51
Est. completion date May 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years old and above Exclusion Criteria: - Allergy or aversion to MSG (monosodium glutamate) or potassium chloride - Those that do not have a smart phone with the ability to download an app. - Those who do not have a full kitchen and the willingness and ability to prepare vegetables according to a recipes. - Those with an allergy, aversion, or dislike to vegetables that would make them not consume any vegetables during the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MSG
MSG to be added to vegetables in diet
NaCl (sodium chloride/table salt)
NaCl (sodium chloride/table salt)
KCl (potassium chloride/salt substitute)
KCl (potassium chloride/salt substitute)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Texas Tech University American Society for Nutrition

Outcome

Type Measure Description Time frame Safety issue
Primary Vegetable Intake How many vegetables were consumed by the participant measured by data from self-recorded diet as entered in smart phone application (My Fitness Pal©). up to 7 days before intervention
Primary Vegetable Intake How many vegetables were consumed by the participant measured by data from self-recorded diet as entered in smart phone application (My Fitness Pal©). for study duration of 4 weeks
Secondary Vegetable Palatability Rating of how enjoyable each vegetable was with each salt in the study. up to 7 days before intervention and 4 weeks