To determine whether 12 weeks of GABA supplementation versus placebo supplementation can improve oral glucose tolerance in people at risk of developing type 2 diabetes and explore the effects of GABA on overall metabolic health.
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Health condition
Hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter of this study is the postprandial glycaemic response
during a 2 hour oral glucose tolerance test (OGTT) before and after the
intervention period.
Secondary outcome
Postprandial insulin and glucagon response, plasma free fatty acids, HbA1c,
glucose variability with flash glucose monitoring, blood pressure, markers of
inflammation, TG and LDL and HDL cholesterol, sleep habits, depression,
anxiety, GABA and glutamate plasma levels and the acute effects of GABA on
postprandial glucose response and blood pressure.
Background summary
Worldwide more and more individuals can be categorized as prediabetic; the
prevalence of prediabetes is expected to be higher than 470 million in 2030.
About 70% of these prediabetics will eventually develop type 2 diabetes.
Diabetes is for a large part preventable and in the stage of prediabetes the
progression to diabetes can still be halted by lifestyle interventions. As a
consequence, there is a clear need for specific foods and food components that
provide additional beneficial effects. Recently identified as potential
bioactive food component is *-aminobutyric acid (GABA). GABA is widely
available as a dietary supplement and it is naturally present in food products
like potato, tomato and melon. Research suggests that oral GABA could function
as a modulator of glucose homeostasis. GABA is able to improve insulin
sensitivity and glucose tolerance in high fat diet induced diabetic rodents and
to reverse chemically induced diabetes in in vivo. However, studies are needed
that can determine what role GABA could play in improving glucose homeostasis
in humans.
Study objective
To determine whether 12 weeks of GABA supplementation versus placebo
supplementation can improve oral glucose tolerance in people at risk of
developing type 2 diabetes and explore the effects of GABA on overall metabolic
health.
Study design
Randomized placebo controlled double-blind parallel intervention study.
Intervention
One group receives three times daily a 500 mg GABA supplement and the other
group receives three times daily a placebo.
Study burden and risks
During this study a total of 116 mL blood is drawn from the research subjects
by a venous catheter. Placement of the catheter could cause bruising. An
additional burden is the 4 times overnight fast. The wearing of the glucose
sensor and the blood pressure monitor might also be perceived as a burden.
During the measurement periods they also fill in a short food record for 5 days
and 3 times a 24 hour webbased recall. They also fill in three short
questionnaires about their sleeping habits, depression and anxiety. GABA is a
food supplement that is present in a similar dose in our diet and is generally
recognized as safe by the FDA. The GABA supplement could have minor temporary
adverse events like dizziness and nausea. Taking these risks and burdens
together this study will be of substantial discomfort to the research subjects.
The research subjects do not directly benefit from the intervention but receive
a financial compensation of ยค390,-.
Stippeneng 4
Wageningen 6708PB
NL
Stippeneng 4
Wageningen 6708PB
NL
Listed location countries
Age
Inclusion criteria
- Age between 50 and 70
- BMI higher or equal to 25 kg/m2
- Impaired fasting glucose (fasting glucose * 5.6 and * 6.9 mmol/L) or/and
- Impaired glucose tolerance (glucose levels * 7.8 and * 11.1 mmol/L, 2-hours
after an OGTT or/and glucose levels *8.6 mmol/L, 1-hour after an OGTT)
Exclusion criteria
- Has been diagnosed with diabetes
- Having other conditions, like liver, pancreatic, cardiovascular,
gastro-intestinal or endocrine diseases, that could influence the study results
- Use of medications or supplements that could influence the study results
- Sensitive to medical skin adhesives
- More than 5kg weight change in the past 12 weeks
- Excessive alcohol consumption (>21 glasses/week for men and >14 glasses/week
for women on average)
- Being an employee of Wageningen University, division Human Nutrition and
Health
- Currently a research subject in other research
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 |
|---|---|
| ClinicalTrials.gov | NCT04303468 |
| CCMO | NL73194.081.20 |