This study aims to establish a plasmakinetic profile of GABA from tomatoes in healthy men and compare it to the kinetic profile of GABA from a supplement. In addition, the effects of glutamate (precursor of GABA) on the plasma-time curves of GABA…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Voedingsonderzoek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the plasma-time curve of GABA. This will be evaluated
using descriptive kinetics: maximum peak height (Cmax), time-to-peak (Tmax),
and area-under-the-curve (AUC).
Secondary outcome
- To evaluate the effects of an oral GABA dose and tomatoes on the plasma
concentrations of glutamate in healthy men.
- To evaluate the effects of a single oral glutamate dose on the plasma
concentrations of GABA and compare this to the plasma concentrations of GABA
after the intake of a tomatoes.
Background summary
Next to its role as a neurotransmitter, GABA has been identified as potential
bioactive food component, abundantly present in for example certain varieties
of potato and tomato. Animal studies show beneficial effects of orally
administered GABA in relation to diabetes development and hypertension. Since
tomatoes and potatoes are frequently consumed by the Dutch (and other
nationalities), these products could potentially be used to substantially
increase the GABA intake. However, this depends on the assumption that GABA is
effectively absorbed from the food matrix. We expect that the food matrix
changes the bio-accessibility and bio-availability of GABA; a food matrix can
entrap nutrients or protect them from degradation for example. From literature
it is known that GABA is rapidly absorbed from a supplement but the
bioavailability of GABA from a food matrix has not previously been
investigated.
Study objective
This study aims to establish a plasmakinetic profile of GABA from tomatoes in
healthy men and compare it to the kinetic profile of GABA from a supplement. In
addition, the effects of glutamate (precursor of GABA) on the plasma-time
curves of GABA will be studied.
Study design
This study has a placebo controlled randomized four-way crossover design, with
four test days with a minimum of 1 week washout in between.
Intervention
On a test day the research subjects will consume either tomatoes with 1 gram of
GABA, a dose of 1 gram GABA supplement dissolved in a maximum of 1 litre water,
a glutamate supplement with a maximum dose of 8 grams, dissolved in a maximum
of 1 litre water or a maximum of 1 litre water. The dosage of glutamate and the
amount of water are adjusted to the amount of glutamate in the pureed tomatoes
and the volume of the pureed tomatoes.
Study burden and risks
GABA and glutamate are naturally present in our diet and are generally
recognised as safe for use as a food ingredient by the FDA. In human
intervention studies, oral ingestion of GABA or glutamate does not lead to
severe adverse events. Some temporary minor adverse events, like nausea, did
occur. Therefore, the research subjects in this study might also experience
these temporary effects. In addition, the research subjects are required to
visit the university a total of 14 times and during the blood sampling they are
required to remain at the research facilities. On the test days the research
subjects arrive in a fasted state and remain fasted until 4 hours after intake
of the test product. The placement of venous catheters and blood sampling will
also lead to mild discomfort. Research subjects do not directly benefit from
the intervention but contribute to scientific research and receive a financial
compensation of ¤470,- when completing the whole study.
Stippeneng 4
Wageningen 6708PB
NL
Stippeneng 4
Wageningen 6708PB
NL
Listed location countries
Age
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 (- 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
- Following a specific diet (e.g. vegetarian, gluten free)
- 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.
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67923.081.19 |
| Other | NL7808 |