IBERICA Clinical Research Center
Eatontown, New Jersey, 07724, United States
NCT Number: NCT01761045
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.
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Notify Me30 year–45 year
Female
Interventional
Not applicable
Eatontown, New Jersey, 07724, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consommé soup with Monosodium L-Glutamate (MSG)
Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP)
Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP)
Time frame: 4-hr postprandial study
Time frame: 3 weeks
Ajinomoto Co., Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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