The Effect of Monosodium L-glutamate (MSG) on Satiety and Energy Intake in Overweight and Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The difference in total energy intake (lunch and snack) compared with a control, as determined by food amount that subject consumed using a food scale (weigh foods before and after).
研究概览
简要总结
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.
详细描述
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.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Premenopausal Female, 19 to 60 yrs old
- •Non-smoker
- •Non-heavy Drinker
- •BMI between 25 and 39.9 inclusive at the screening visit (with average BMI 30)
- •no reported current or previous metabolic diseases or chronic gastrointestinal disorders
- •no medically prescribed diet, no slimming diet, used to eating 3 meals a day and snacking
- •No blood donation during the study
- •Reported intense sporting activities ≤ 10h/w
- •Reported alcohol consumption ≤14 units/w
- •Informed consent signed
- •Recruitment form filled out
排除标准
- •Vegetarian
- •Disliking the meals provided on the test day, have allergy or intolerance to test products or study meals
- •Use of medication which interferes with study measurements (as judged by the study physician).
- •Possible eating disorder (measured by SCOFF questionnaire score >1)
- •Current depression measured by BDI <10
- •Pregnant during the study period or in the six months prior to pre-study investigation
- •Reported lactating 6 weeks before pre-study investigation and during the study
- •Reported weight loss or gain ≥ 10 % of bodyweight during a period of six months before pre-study examination.
- •Eating disorder (measured by SCOFF questionnaire, ≥2 "yes" responses)
- •Reported participation in another biomedical trial 1 month before the start of the study
结局指标
主要结局
The difference in total energy intake (lunch and snack) compared with a control, as determined by food amount that subject consumed using a food scale (weigh foods before and after).
时间窗: 8 hours 30 min Postprandial Study
food will be measured before and after using a food scale (weight out and in)
次要结局
- The difference in energy intake only at lunch compared with a control, as determined by food amount that subject consumed using a food scale (weigh foods before and after).(8 hours 30 min Postprandial Study)
- The difference in energy intake of snack only compared with a control(8 hours 30 min Postprandial Study)