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Intervention With a GABA Supplement in Prediabetics

The Effects of a GABA Supplement Versus a Placebo on Glucose Tolerance and Blood Pressure in Prediabetics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20448
Enrollment
52
Registered
2020-03-04
Start date
2020-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes, hypertension

Interventions

Sponsors

TKI funded project with industrial sponsors Nunhems, Agrico Research and Avebe
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Postprandial glycaemic response during a 2 hour oral glucose tolerance test (OGTT)

Secondary

MeasureTime frame
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

Contacts

Public ContactTessa de Bie

Wageningen University

tessa.debie@wur.nl0317481100

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)