MedPath

Relative Oral Bioavailability of GABA From Tomatoes

Not Applicable
Completed
Conditions
GABA Plasmakinetics
Interventions
Dietary Supplement: Tomato
Dietary Supplement: Glutamate supplement
Dietary Supplement: GABA supplement
Registration Number
NCT04086108
Lead Sponsor
Wageningen University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
12
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
TomatoTomatoSingle oral administration
Glutamate supplementGlutamate supplementSingle oral administration
GABA supplementGABA supplementSingle oral administration
Primary Outcome Measures
NameTimeMethod
Half-life (T1/2) of plasma-time curves of GABA6 months

After intake of a GABA supplement and tomatoes.

Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA6 months

After intake of a GABA supplement and tomatoes.

Peak Plasma Concentration (Cmax) of plasma-time curves of GABA6 months

After intake of a GABA supplement and tomatoes.

Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA6 months

After intake of a GABA supplement and tomatoes.

Secondary Outcome Measures
NameTimeMethod
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate6 months

After intake of a glutamate supplement and tomatoes

Half-life (T1/2) of plasma-time curves of GABA in response to a glutamate supplement.6 months

This will be compared to the plasma time-curves of GABA after tomato intake.

Area under the plasma concentration versus time curve (AUC) AUC of plasma-time curves of GABA in response to a glutamate supplement.6 months

This 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 months

This will be compared to the plasma time-curves of GABA after tomato intake.

Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate6 months

After intake of a glutamate supplement and tomatoes

Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate6 months

After intake of a glutamate supplement and tomatoes

Half-life (T1/2) of plasma-time curves of glutamate6 months

After intake of a glutamate supplement and tomatoes

Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA in response to a glutamate supplement.6 months

This will be compared to the plasma time-curves of GABA after tomato intake.

Trial Locations

Locations (1)

Wageningen University, Division of Human Nutrition

🇳🇱

Wageningen, Netherlands

© Copyright 2025. All Rights Reserved by MedPath