Clinical trial NCT04086108: Relative Oral Bioavailability of GABA From Tomatoes
Official title: Plasmakinetics of GABA From Tomatoes as Compared to GABA From a Supplement, After a Single Oral Administration in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GABA Plasmakinetics
Keywords: GABA
Glutamate
Tomato
Plasmakinetics
Bioavailability
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Nunhems
name: Agrico Research
name: Avebe
First posted: 2019-09-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA
timeFrame: 6 months
measure: Peak Plasma Concentration (Cmax) of plasma-time curves of GABA
timeFrame: 6 months
measure: Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA
timeFrame: 6 months
measure: Half-life (T1/2) of plasma-time curves of GABA
timeFrame: 6 months
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate
timeFrame: 6 months
measure: Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate
timeFrame: 6 months
measure: Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate
timeFrame: 6 months
measure: Half-life (T1/2) of plasma-time curves of glutamate
timeFrame: 6 months
measure: Area under the plasma concentration versus time curve (AUC) AUC of plasma-time curves of GABA in response to a glutamate supplement.
timeFrame: 6 months
measure: Peak Plasma Concentration (Cmax) of plasma-time curves of GABA in response to a glutamate supplement.
timeFrame: 6 months
measure: Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA in response to a glutamate supplement.
timeFrame: 6 months
measure: Half-life (T1/2) of plasma-time curves of GABA in response to a glutamate supplement.
timeFrame: 6 months
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
Study officials:
affiliation: Wageningen University
name: Renger Witkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Bie TH, Balvers MGJ, de Vos RCH, Witkamp RF, Jongsma MA. The influence of a tomato food matrix on the bioavailability and plasma kinetics of oral gamma-aminobutyric acid (GABA) and its precursor glutamate in healthy men. Food Funct. 2022 Aug 15;13(16):8399-8410. doi: 10.1039/d2fo01358d.