Status:
COMPLETED
Intervention With a GABA Supplement in Prediabetics
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Nunhems
Agrico Research
Conditions:
Prediabetes
Hypertension
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief 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 wi...
Eligibility Criteria
Inclusion
- Age between 50 and 70
- BMI higher or equal to 27 kg/m2
- Impaired fasting glucose (fasting glucose ≥ 6.1 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
- 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
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04303468
Start Date
September 29 2020
End Date
September 8 2021
Last Update
November 16 2021
Active Locations (1)
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1
Wageningen University, Division of Human Nutrition
Wageningen, Netherlands