Relative Oral Bioavailability of GABA From Tomatoes

NCT04086108 | Completed

• 1 other identifier: 19/13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

GABA Plasmakinetics

Keywords

GABA; Glutamate; Tomato; Plasmakinetics; Bioavailability

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA

  After intake of a GABA supplement and tomatoes.

  6 months

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

  After intake of a GABA supplement and tomatoes.

  6 months

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

  After intake of a GABA supplement and tomatoes.

  6 months

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

  After intake of a GABA supplement and tomatoes.

  6 months

Secondary Outcomes (8)

• Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate

  6 months

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

  6 months

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

  6 months

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

  6 months

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

  6 months

Study Arms (4)

Tomato

EXPERIMENTAL

Single oral administration

Dietary Supplement: Tomato

GABA supplement

EXPERIMENTAL

Single oral administration

Dietary Supplement: GABA supplement

Glutamate supplement

EXPERIMENTAL

Single oral administration

Dietary Supplement: Glutamate supplement

Placebo

NO INTERVENTION

Single oral administration, same volume of water that is distributed in the other arms

Interventions

Tomato DIETARY_SUPPLEMENT

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

Tomato

GABA supplement DIETARY_SUPPLEMENT

1 gram of GABA dissolved in water.

Also known as: Gamma-aminobutyric acid

GABA supplement

Glutamate supplement DIETARY_SUPPLEMENT

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

Glutamate supplement

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Wageningen University: lead
• Nunhems: collaborator
• Agrico Research: collaborator
• Avebe: collaborator

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 35852458 DERIVED

MeSH Terms

Interventions

gamma-Aminobutyric Acid

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Renger Witkamp, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: September 11, 2019
• Study Start: November 4, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

NL (1)