Nutrition Intervention Clinical Trial
Official title:
The Effect of Monosodium L-glutamate (MSG) on Satiety and Energy Intake in Overweight and Obese Women
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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