Intervention With a GABA Supplement in Prediabetics

Wageningen University52 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Prediabetes Hypertension

Interventions

GABADIETARY_SUPPLEMENT

The dietary supplement GABA will be taken orally 3 times daily, before each main meal

PlaceboOTHER

Gelatin capsule containing powdered cellulose

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wageningen University, Division of Human Nutrition

Wageningen, Netherlands

Outcomes

Primary Outcomes

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

A 2 hour oral glucose tolerance test with 75gr glucose

Time frame: blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention

Secondary Outcomes

Postprandial insulin and glucagon response during a 2 hour OGTT,

A 2 hour oral glucose tolerance test with 75gr glucose

Time frame: blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention

Plasma free fatty acids

Time frame: before and after the 12 weeks intervention

HbA1c

Time frame: before and after the 12 weeks intervention

Glucose variability

The participants wear a flash glucose monitoring sensor with which their interstitial glucose is measured every 15 minutes.

Time frame: 5 days during which they eat their habitual diet, before and after the 12 weeks intervention

Blood pressure

Single measurement and a dynamic measurement: * Mean day systolic and diastolic blood pressure * Mean night systolic and diastolic blood pressure * Time below or above 120/80 mmHg

Time frame: Dynamic measurement: 24 hours, before and after the 12 weeks intervention

Heart rate

Time frame: before and after the 12 weeks intervention

Concentrion of markers of inflammation in blood

C-reactive protein and cytokines like IL-6 and TNF-alpha

Data from ClinicalTrials.gov

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