Intervention With a GABA Supplement in Prediabetics

Wageningen University

Status: Completed

Conditions: Hypertension; Prediabetes

Treatments: Other: Placebo; Dietary Supplement: GABA

Study type: Interventional

Funder types: Other

Identifiers

NCT04303468

NL73194.081.20

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

GABA

Experimental group

Description:

GABA is a nutrient commonly present in our diet in for example tomatoes and potatoes. It is also commercially sold as dietary supplement. A dose of 500 mg, 3 times daily is used

Treatment:

Dietary Supplement: GABA

Placebo

Placebo Comparator group

Description:

The placebo consists of capsules containing powdered cellulose.

Treatment:

Other: Placebo