- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05591612
Increasing Vegetable Intake Using Monosodium Glutamate: A Reduced-Effort Intervention
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shannon Galyean, PhD
- Phone Number: (806)834-2286
- Email: shannon.galyean@ttu.edu
Study Contact Backup
- Name: Carson Maher, B.S
- Email: carmaher@ttu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MSG (Monosodium Glutamate)
Vegetables and foods prepared with MSG
|
MSG to be added to vegetables in diet
|
Other: NaCl (sodium chloride/table salt)
Active control/Standard practice Vegetables and foods prepared with table salt
|
NaCl (sodium chloride/table salt)
|
Experimental: KCl (potassium chloride/salt substitute)
Vegetables and foods prepared with KCl
|
KCl (potassium chloride/salt substitute)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vegetable Intake
Time Frame: up to 7 days before intervention
|
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
|
Vegetable Intake
Time Frame: for study duration of 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vegetable Palatability
Time Frame: up to 7 days before intervention and 4 weeks
|
Rating of how enjoyable each vegetable was with each salt in the study.
|
up to 7 days before intervention and 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-396
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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