Relative Oral Bioavailability of GABA From Tomatoes

Overview

In this four-way crossover study, we will establish a plasmakinetic profile of GABA from tomatoes as compared to a gamma-aminobutyric acid (GABA) supplement in healthy young men. In addition, we will determine 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. This study will therefore provide information about the effect of a food matrix on GABA plasmakinetics.

Full Title of Study: “Plasmakinetics of GABA From Tomatoes as Compared to GABA From a Supplement, After a Single Oral Administration in Healthy Young Men”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2019

Interventions

  • Dietary Supplement: Tomato
    • A maximum of 1 kilo pureed tomatoes, containing 1 gram of GABA.
  • Dietary Supplement: GABA supplement
    • 1 gram of GABA dissolved in water.
  • Dietary Supplement: Glutamate supplement
    • A maximum of 8 grams glutamate, adjusted to amount of glutamate given in the tomato arm. Dissolved in water.

Arms, Groups and Cohorts

  • Experimental: Tomato
    • Single oral administration
  • Experimental: GABA supplement
    • Single oral administration
  • Experimental: Glutamate supplement
    • Single oral administration
  • No Intervention: Placebo
    • Single oral administration, same volume of water that is distributed in the other arms

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 28 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wageningen University
  • Collaborator
    • Nunhems
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Renger Witkamp, PhD, Principal Investigator, Wageningen University
  • Overall Contact(s)
    • Tessa H de Bie, MSc, +31317481100, tessa.debie@wur.nl

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