Relative Oral Bioavailability of GABA From Tomatoes

GABA Plasmakinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086108
• Other study ID #: 19/13
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: December 5, 2019

Study information

• Verified date: January 2020
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 28 Years

Eligibility

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.

Related Conditions & MeSH terms

• GABA Plasmakinetics

Intervention

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

Locations

Country	Name	City	State
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen

Sponsors (4)

Lead Sponsor	Collaborator
Wageningen University	Agrico Research, Avebe, Nunhems

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Peak Plasma Concentration (Cmax) of plasma-time curves of GABA	After intake of a GABA supplement and tomatoes.	6 months
Primary	Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA	After intake of a GABA supplement and tomatoes.	6 months
Primary	Half-life (T1/2) of plasma-time curves of GABA	After intake of a GABA supplement and tomatoes.	6 months
Secondary	Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate	After intake of a glutamate supplement and tomatoes	6 months
Secondary	Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate	After intake of a glutamate supplement and tomatoes	6 months
Secondary	Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate	After intake of a glutamate supplement and tomatoes	6 months
Secondary	Half-life (T1/2) of plasma-time curves of glutamate	After intake of a glutamate supplement and tomatoes	6 months
Secondary	Area under the plasma concentration versus time curve (AUC) AUC of plasma-time curves of GABA in response to a glutamate supplement.	This will be compared to the plasma time-curves of GABA after tomato intake.	6 months
Secondary	Peak Plasma Concentration (Cmax) of plasma-time curves of GABA in response to a glutamate supplement.	This will be compared to the plasma time-curves of GABA after tomato intake.	6 months
Secondary	Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA in response to a glutamate supplement.	This will be compared to the plasma time-curves of GABA after tomato intake.	6 months
Secondary	Half-life (T1/2) of plasma-time curves of GABA in response to a glutamate supplement.	This will be compared to the plasma time-curves of GABA after tomato intake.	6 months