Skip to main content
OpenTrials
Completed

NCT Number: NCT04086108

Relative Oral Bioavailability of GABA From Tomatoes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–28 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tomato

Dietary Supplement

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

GABA supplement

Dietary Supplement

1 gram of GABA dissolved in water.

Other names: Gamma-aminobutyric acid

Glutamate supplement

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. Peak Plasma Concentration (Cmax) of plasma-time curves of GABA

    Time frame: 6 months

    After intake of a GABA supplement and tomatoes.

  3. Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA

    Time frame: 6 months

    After intake of a GABA supplement and tomatoes.

  4. Half-life (T1/2) of plasma-time curves of GABA

    Time frame: 6 months

    After intake of a GABA supplement and tomatoes.

Secondary outcomes

  1. 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

  2. Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate

    Time frame: 6 months

    After intake of a glutamate supplement and tomatoes

  3. Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate

    Time frame: 6 months

    After intake of a glutamate supplement and tomatoes

  4. Half-life (T1/2) of plasma-time curves of glutamate

    Time frame: 6 months

    After intake of a glutamate supplement and tomatoes

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Agrico Research
  • Avebe
  • Nunhems

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2019
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.