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ID
Source
Brief title
Health condition
Prediabetes, hypertension
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postprandial glycaemic response during a 2 hour oral glucose tolerance test (OGTT)
Secondary outcome
Other parameters of type 2 diabetes risk:
o Postprandial insulin and glucagon response during a 2 hour OGTT, measured at baseline,
30, 60 and 120 minutes after intake of the glucose drink
o Plasma free fatty acids before and after the intervention
o HbA1c before and after the intervention period
o Interstitial glucose every 15 minutes during 14 days before and after the intervention period
with a FGM device
During 5 days of normal eating before and after the intervention period
o Blood pressure
Single measurement before and after the intervention
Dynamic measurement during an entire day, before and after the intervention and after
a single dose of GABA
• Mean day SBP and DBP
• Mean night SBP and DBP
• Time below or above 120/80 mmHg
o Heart rate
o Markers of inflammation in blood
o TG and LDL and HDL cholesterol
o Liver enzymes ALAT and ASAT
Acute effects of GABA
o Postprandial glucose after an OGTT, measured with the freestyle libre sensor
o Dynamic blood pressure for 24 hours
Other
o PSQI sleep questionnaire, PHQ-9 depression questionnaire and GAD-7 anxiety
questionnaire
o GABA and glutamate plasma levels before and after the intervention
Background summary
In this double-blind parallel placebo controlled intervention study the effects of 3 times daily 500 mg gamma-aminobutyric acid (GABA) supplementation on glucose tolerance and cardiovascular health will be assessed in prediabetics.
Study objective
We hypothesize that GABA could improve glucose tolerance and cardiovascular health after long-term supplementation
Study design
Parameters will be measured before and after the 12 week intervention period
Intervention
GABA supplement
Inclusion criteria
Age between 50 and 70
BMI higher or equal to 27 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
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8796 |
| Other | METC-WU : 20/07 |