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Relative Oral Bioavailability of GABA From Tomatoes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04086108
Enrollment
12
Registered
2019-09-11
Start date
2019-11-04
Completion date
2019-12-05
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GABA Plasmakinetics

Keywords

GABA, Glutamate, Tomato, Plasmakinetics, Bioavailability

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTTomato

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

DIETARY_SUPPLEMENTGABA supplement

1 gram of GABA dissolved in water.

DIETARY_SUPPLEMENTGlutamate supplement

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

Sponsors

Nunhems
CollaboratorUNKNOWN
Agrico Research
CollaboratorUNKNOWN
Avebe
CollaboratorUNKNOWN
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
18 Years to 28 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA6 monthsAfter intake of a GABA supplement and tomatoes.
Peak Plasma Concentration (Cmax) of plasma-time curves of GABA6 monthsAfter intake of a GABA supplement and tomatoes.
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA6 monthsAfter intake of a GABA supplement and tomatoes.
Half-life (T1/2) of plasma-time curves of GABA6 monthsAfter intake of a GABA supplement and tomatoes.

Secondary

MeasureTime frameDescription
Half-life (T1/2) of plasma-time curves of glutamate6 monthsAfter intake of a glutamate supplement and tomatoes
Area under the plasma concentration versus time curve (AUC) AUC of plasma-time curves of GABA in response to a glutamate supplement.6 monthsThis will be compared to the plasma time-curves of GABA after tomato intake.
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA in response to a glutamate supplement.6 monthsThis will be compared to the plasma time-curves of GABA after tomato intake.
Half-life (T1/2) of plasma-time curves of GABA in response to a glutamate supplement.6 monthsThis will be compared to the plasma time-curves of GABA after tomato intake.
Peak Plasma Concentration (Cmax) of plasma-time curves of GABA in response to a glutamate supplement.6 monthsThis will be compared to the plasma time-curves of GABA after tomato intake.
Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate6 monthsAfter intake of a glutamate supplement and tomatoes
Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate6 monthsAfter intake of a glutamate supplement and tomatoes
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate6 monthsAfter intake of a glutamate supplement and tomatoes

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026