Plasmakinetics of GABA From Tomatoes as Compared to GABA From a Supplement, After a Single Oral Administration in Healthy Young Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Half-life (T1/2) of plasma-time curves of GABA
研究概览
简要总结
In this four-way crossover study, a plasmakinetic profile of GABA from tomatoes as compared to a gamma-aminobutyric acid (GABA) supplement in healthy young men will be established. In addition, a plasmakinetic profiles of glutamate from a supplement and from tomatoes as well as the effects of glutamate from tomatoes and a supplement on the GABA plasma levels will be determined. This study will therefore provide information about the effect of a food matrix on GABA plasmakinetics.
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
- None
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5 and 25 kg/m2
- •Age is between 18 and 28 years
- •Good general health
- •Veins suitable for blood sampling
- •Able to speak Dutch
排除标准
- •Is currently suffering from a disease including mental disorders
- •Has had any gastrointestinal condition/disease within the 3 months prior to the intervention
- •Haemoglobin (Hb) level < 8.5 mmol/L
- •Has used medication in the two months before and/or during the intervention. Occasional use of NSAIDs or paracetamol (<once a week on average) are is allowed.
- •Reported weight loss or weight gain of > 2 kg in the month prior to the intervention
- •Use of dietary supplements, 3 weeks before-, or during the intervention.
- •Allergic to products that are provided as part of the standardised diet
- •Unwilling to consume the products that are part of the standardised diet
- •Allergic to tomatoes
- •(History of) drug abuse, in this case meaning >1 x per month use of recreational drugs
- •Alcohol consumption of >10 standardised glasses per week.
- •Not able to refrain from alcohol consumption 2 days before each test day
- •Recent or planned blood donation (<3 month prior to first study day or during intervention)
- •Personnel of Wageningen University, department of Human Nutrition and Health,
- •Currently participating in other research or was participating in another study within 1 month of the intervention or within 3 months if invasive procedures were used.
结局指标
主要结局
Half-life (T1/2) of plasma-time curves of GABA
时间窗: 6 months
After intake of a GABA supplement and tomatoes.
Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA
时间窗: 6 months
After intake of a GABA supplement and tomatoes.
Peak Plasma Concentration (Cmax) of plasma-time curves of GABA
时间窗: 6 months
After intake of a GABA supplement and tomatoes.
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA
时间窗: 6 months
After intake of a GABA supplement and tomatoes.
次要结局
- Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate(6 months)
- Half-life (T1/2) of plasma-time curves of GABA in response to a glutamate supplement.(6 months)
- Area under the plasma concentration versus time curve (AUC) AUC of plasma-time curves of GABA in response to a glutamate supplement.(6 months)
- Peak Plasma Concentration (Cmax) of plasma-time curves of GABA in response to a glutamate supplement.(6 months)
- Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate(6 months)
- Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate(6 months)
- Half-life (T1/2) of plasma-time curves of glutamate(6 months)
- Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA in response to a glutamate supplement.(6 months)