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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Differences in food intake and subjective satiety motivational responses to treatments
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Female, 30 to 45 yrs old
- •Non-smoker
- •Non-heavy Drinker
- •BMI between 18.5 and 25.0 inclusive at the screening visit
排除标准
- •History or presence of any serious and/or chronic medical or clinical disease, including renal disease, hepatic (biliary) disease, uncontrolled hypertension or uncontrolled thyroid disease, surgical conditions, cardiovascular disease other than mild hypertension or dyslipidemias, myocardial infarction, or other conditions that in the opinion of the investigator may increase the risk of participation or compromise/confound the study results
- •History or diagnosis of type 1 or 2 diabetes mellitus or other uncontrolled endocrine disease
- •Dysgeusia
- •Any history of gastrointestinal disease or currently on treatment for a digestive disease
- •Eating disorder or abnormal eating habits
- •Undergone a recent significant weight change (gain or loss)
- •Participating on a weight-loss program within the past 6 months prior to entry into the study
- •Taking any medications for the alimentary system
- •Allergy or sensitivity to foods or food additives
- •History of using habitual drugs and/or alcohol abuse within the past year
- •Psychosis and/or suffering from any other condition(s) which might render the individual unable to comply with the protocol or place subjects at increased risk at the discretion of the PI
- •Used any investigational drug or product within the 1 month prior to the screening visit
- •On special diet such as vegetarian
- •Dislike the preloading soup and/or the provided lunch and/or study snacks
- •Currently breast feeding and/or pregnant in the past 6 months
结局指标
主要结局
Differences in food intake and subjective satiety motivational responses to treatments
时间窗: 4-hr postprandial study
次要结局
- Correlation between genetic makeup of the subject and the primary efficacy endpoints.(3 weeks)