Nutrition Intervention Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Study of Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP) to Evaluate the Effects on Satiety and Food Intakes at the Next Meal in Healthy Adults
The objective of this study is to confirm that Monosodium L-Glutamate (MSG) supplementation, both alone or in combination with Nucleic Acid (IMP), enhances satiety and decreases food intakes at the next meal in healthy female adults.
The study is a randomized, double-blind, placebo-controlled, cross-over clinical trial. A
total of 80 women aged 30 to 45 y will be randomized to a sequence of test product
administration.
Subjects will be required to meet several inclusion and exclusion criteria, which will be
assessed at the screening visit, including a general screening questionnaire,
medical/medication history, eating disorder questionnaire, eating inventory questionnaire,
dietary inventory questionnaire, and anthropometric and vital sign measurements. At the
screening visit, a urine sample will be collected for drug and alcohol screening, cotinine
level, and pregnancy. Alcohol breath test will be performed as well.
After assessment of the eligibility criteria, qualified subjects will be invited to
participate in the study. This study will take approximately 3 weeks to complete.
Subjects will return to the study site within 28 days after the screening visit for testing
period 1, followed by 2 additional visits (testing period 2 and 3).
Subjects will consume 1 of 3 treatments, based on randomization sequence at each test period
visit: Consommé soup with Monosodium L-Glutamate (MSG), Consommé soup with MSG and Nucleic
Acid (IMP), and Placebo soup with no MSG or IMP.
When subjects arrive at the research center at approximately 11:30am, admission procedures
will be conducted: an alcohol breath test, food and activity diary review, and vital signs
and weight will be measured. If vital sign measurements are elevated, subjects will be
rescheduled within 2-3 days. Right before serving the standard lunch meal, subjects will be
asked to complete a satiety motivational questionnaire. Subjects will consume the entire
standard lunch meal and water within 30 min. Immediately after eating the standard lunch
meal, subjects will complete the satiety motivational questionnaire.
Two hours after the standard lunch meal, subjects will be given one of the test soups (based
on their randomization) to consume in its entirety, followed by completion of the satiety
motivational questionnaire and the soup rating questionnaire. Fifteen minutes from test soup
administration, snacks and water (ad lib) will be provided and subjects will be instructed
to eat as much as or as little as they desire, followed by completing the satiety
motivational questionnaire. At 3 h 15 min and at 4 h, subjects will complete the satiety
motivational questionnaire.
Test periods 2 and 3 will be scheduled between 3-14 days after completing test period visit
1: all procedures are identical on each test period visit with the exception of the test
treatment soup consumed by subjects.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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