Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-22 @ 8:48 AM
Study NCT ID:
NCT02446106
Status:
COMPLETED
Last Update Posted:
2015-05-18
First Post:
2015-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monosodium L-glutamate (MSG) on Satiety
Sponsor:
Ajinomoto Co., Inc.
Organization:
Study Overview
Official Title:
The Effect of Monosodium L-glutamate (MSG) on Satiety and Energy Intake in Overweight and Obese Women
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to compare energy intake following consumption 0.5% MSG versus a control with no added MSG and matched for sodium in healthy non-smoking premenopausal female adults.
Detailed Description:
The study is a randomized, 2-arm, double-blind, placebo-controlled, Latin square cross-over clinical trial to assess the impact of 0.5% MSG on total and meal/snack-specific energy intake and on subjective ratings of appetite compared to sodium. Subjects will partake in an adaptation visit to avoid first order effects and will not be included in the randomization.
A total of 75 healthy premenopausal women aged 19 to 60 y (inclusive) will be randomized to a sequence of test product administration. Participants will consume 1 of 2 test products, based on randomization sequence at each test period visit. Carrot and coriander soup (0.5% MSG + 0.48% salt) or negative control match for sodium (no MSG + 0.635% salt).
Participants will be required to meet several inclusion and exclusion criteria, which will be assessed at the screening visit, including a health questionnaire, medical/medication history, eating behavior questionnaires, depression questionnaire and anthropometric measurements. After assessment of the eligibility criteria (see Eligibility section) at the screening visit, qualified participants will be invited to participate in the study and will be familiarized with the completion of VAS for subjective ratings of hunger, fullness, satiety and desire to eat.
Over a 3-week period, participants will come to the test facility on three occasions to complete the study with a one week wash-out period between each visit. Participants will fast overnight before each visit and consume the same evening meal before each test day.
Participants arrive at the research center at approximately 8:15am. Right before serving the breakfast meal, participants will be asked to complete a satiety rating questionnaire (using visual analogue scale (VAS)). At 8:30am, participants will consume breakfast (cereal and milk). Immediately after eating breakfast participants will complete another VAS questionnaire as well as a taste/liking meal evaluation. Thereafter, VAS will be completed at 30 minute intervals.
Four hours after the breakfast meal (at 12:30pm), participants will be given one of the test products (carrot and coriander soup with or without MSG) based on their randomization schedule. Subjects will have 10 min to consume the soup in its entirety. Following test product/soup intake, subjects will complete a taste/liking meal evaluation and VAS questionnaire. Immediately after completion of the questionnaire (12:40pm), an ad lib lunch buffet will be provided and participants will be instructed to eat as much as or as little as they desire (within 30 min) until comfortably full, followed by completing a taste/liking meal evaluation and VAS questionnaire. Thereafter, VAS will be completed at 30 minute intervals.
At 3:30pm, participants will be provided with their second portion of the test product to consume within 10 min, followed by completing a taste/liking meal evaluation and VAS questionnaire. Immediately after test soup administration and completing questionnaires, an ad lib snack buffet will be provided and participants will be instructed to eat as much as or as little as they desire within 20 min, followed by completing a taste/liking meal evaluation and VAS questionnaire. VAS assessment will continue at 30 min intervals thereafter until 5:00pm ending the study day. Participants' next visit will be scheduled after 1 week wash-out period: all procedures are identical with the exception of the test treatment soup consumed by participants.
A total of 75 healthy premenopausal women aged 19 to 60 y (inclusive) will be randomized to a sequence of test product administration. Participants will consume 1 of 2 test products, based on randomization sequence at each test period visit. Carrot and coriander soup (0.5% MSG + 0.48% salt) or negative control match for sodium (no MSG + 0.635% salt).
Participants will be required to meet several inclusion and exclusion criteria, which will be assessed at the screening visit, including a health questionnaire, medical/medication history, eating behavior questionnaires, depression questionnaire and anthropometric measurements. After assessment of the eligibility criteria (see Eligibility section) at the screening visit, qualified participants will be invited to participate in the study and will be familiarized with the completion of VAS for subjective ratings of hunger, fullness, satiety and desire to eat.
Over a 3-week period, participants will come to the test facility on three occasions to complete the study with a one week wash-out period between each visit. Participants will fast overnight before each visit and consume the same evening meal before each test day.
Participants arrive at the research center at approximately 8:15am. Right before serving the breakfast meal, participants will be asked to complete a satiety rating questionnaire (using visual analogue scale (VAS)). At 8:30am, participants will consume breakfast (cereal and milk). Immediately after eating breakfast participants will complete another VAS questionnaire as well as a taste/liking meal evaluation. Thereafter, VAS will be completed at 30 minute intervals.
Four hours after the breakfast meal (at 12:30pm), participants will be given one of the test products (carrot and coriander soup with or without MSG) based on their randomization schedule. Subjects will have 10 min to consume the soup in its entirety. Following test product/soup intake, subjects will complete a taste/liking meal evaluation and VAS questionnaire. Immediately after completion of the questionnaire (12:40pm), an ad lib lunch buffet will be provided and participants will be instructed to eat as much as or as little as they desire (within 30 min) until comfortably full, followed by completing a taste/liking meal evaluation and VAS questionnaire. Thereafter, VAS will be completed at 30 minute intervals.
At 3:30pm, participants will be provided with their second portion of the test product to consume within 10 min, followed by completing a taste/liking meal evaluation and VAS questionnaire. Immediately after test soup administration and completing questionnaires, an ad lib snack buffet will be provided and participants will be instructed to eat as much as or as little as they desire within 20 min, followed by completing a taste/liking meal evaluation and VAS questionnaire. VAS assessment will continue at 30 min intervals thereafter until 5:00pm ending the study day. Participants' next visit will be scheduled after 1 week wash-out period: all procedures are identical with the exception of the test treatment soup consumed by participants.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: