Relative Oral Bioavailability of GABA From Tomatoes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2019-12-05

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.

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Detailed Description

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Conditions

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GABA Plasmakinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

For the study, research subjects will visit the university on four test days separated by a wash out period of one week.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tomato

Single oral administration

Group Type EXPERIMENTAL

Tomato

Intervention Type DIETARY_SUPPLEMENT

A maximum of 1 kilo pureed tomatoes, containing 1 gram of GABA.

GABA supplement

Single oral administration

Group Type EXPERIMENTAL

GABA supplement

Intervention Type DIETARY_SUPPLEMENT

1 gram of GABA dissolved in water.

Glutamate supplement

Single oral administration

Group Type EXPERIMENTAL

Glutamate supplement

Intervention Type DIETARY_SUPPLEMENT

A maximum of 8 grams glutamate, adjusted to amount of glutamate given in the tomato arm. Dissolved in water.

Placebo

Single oral administration, same volume of water that is distributed in the other arms

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tomato

A maximum of 1 kilo pureed tomatoes, containing 1 gram of GABA.

Intervention Type DIETARY_SUPPLEMENT

GABA supplement

1 gram of GABA dissolved in water.

Intervention Type DIETARY_SUPPLEMENT

Glutamate supplement

A maximum of 8 grams glutamate, adjusted to amount of glutamate given in the tomato arm. Dissolved in water.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Gamma-aminobutyric acid

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes