Relative Oral Bioavailability of GABA From Tomatoes

Study Overview
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Brief Summary
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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.

Official Title
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Plasmakinetics of GABA From Tomatoes as Compared to GABA From a Supplement, After a Single Oral Administration in Healthy Young Men

Conditions
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GABA Plasmakinetics

Intervention / Treatment
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* Dietary Supplement: Tomato
* Dietary Supplement: GABA supplement
* Dietary Supplement: Glutamate supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 18.5 and 25 kg/m2 Age is between 18 and 28 years Good general health Male Veins suitable for blood sampling Able to speak Dutch Exclusion Criteria: 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 Smoking 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: For the study, research subjects will visit the university on four test days separated by a wash out period of one week.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tomato<br>Single oral administration | Dietary Supplement: Tomato<br>* A maximum of 1 kilo pureed tomatoes, containing 1 gram of GABA.<br>|
| Experimental: GABA supplement<br>Single oral administration | Dietary Supplement: GABA supplement<br>* 1 gram of GABA dissolved in water.<br>* Other names: Gamma-aminobutyric acid;|
| Experimental: Glutamate supplement<br>Single oral administration | Dietary Supplement: Glutamate supplement<br>* A maximum of 8 grams glutamate, adjusted to amount of glutamate given in the tomato arm. Dissolved in water.<br>|
| No Intervention: Placebo<br>Single oral administration, same volume of water that is distributed in the other arms | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA | After intake of a GABA supplement and tomatoes. | 6 months | 
| Peak Plasma Concentration (Cmax) of plasma-time curves of GABA | After intake of a GABA supplement and tomatoes. | 6 months | 
| Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA | After intake of a GABA supplement and tomatoes. | 6 months | 
| Half-life (T1/2) of plasma-time curves of GABA | After intake of a GABA supplement and tomatoes. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate | After intake of a glutamate supplement and tomatoes | 6 months | 
| Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate | After intake of a glutamate supplement and tomatoes | 6 months | 
| Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate | After intake of a glutamate supplement and tomatoes | 6 months | 
| Half-life (T1/2) of plasma-time curves of glutamate | After intake of a glutamate supplement and tomatoes | 6 months | 
| Area under the plasma concentration versus time curve (AUC) AUC of plasma-time curves of GABA in response to a glutamate supplement. | This will be compared to the plasma time-curves of GABA after tomato intake. | 6 months | 
| Peak Plasma Concentration (Cmax) of plasma-time curves of GABA in response to a glutamate supplement. | This will be compared to the plasma time-curves of GABA after tomato intake. | 6 months | 
| Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA in response to a glutamate supplement. | This will be compared to the plasma time-curves of GABA after tomato intake. | 6 months | 
| Half-life (T1/2) of plasma-time curves of GABA in response to a glutamate supplement. | This will be compared to the plasma time-curves of GABA after tomato intake. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GABA, Glutamate, Tomato, Plasmakinetics, Bioavailability