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Completed

NCT Number: NCT04303468

Intervention With a GABA Supplement in Prediabetics

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.

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Key information

Conditions

PreDiabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State Vascular Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GABA

Dietary Supplement

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

Placebo

Other

Gelatin capsule containing powdered cellulose

Primary outcomes

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

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

    A 2 hour oral glucose tolerance test with 75gr glucose

Secondary outcomes

  1. Postprandial insulin and glucagon response during a 2 hour OGTT,

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

    A 2 hour oral glucose tolerance test with 75gr glucose

  2. Plasma free fatty acids

    Time frame: before and after the 12 weeks intervention

  3. HbA1c

    Time frame: before and after the 12 weeks intervention

  4. Glucose variability

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

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

  5. Blood pressure

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

    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

  6. Heart rate

    Time frame: before and after the 12 weeks intervention

  7. Concentrion of markers of inflammation in blood

    Time frame: before and after the 12 weeks intervention

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

  8. Concentration of triglycerides in blood

    Time frame: before and after the 12 weeks intervention

  9. Concentration of LDL and HDL cholesterol in blood

    Time frame: before and after the 12 weeks intervention

  10. Concentration of ALAT and ASAT in blood

    Time frame: before and after the 12 weeks intervention

  11. Acute effects of GABA on postprandial glucose

    Time frame: 2 hours, after a single administration of 500 mg GABA

    Assessed with an OGTT during which interstitial glucose is measured with flash glucose monitoring

  12. Acute effects of GABA on blood pressure

    Time frame: for 24 hours during which GABA is taken 3 times, each time before the main meal

    Assessed with an ambulatory blood pressure monitor

  13. Sleep quality

    Time frame: before and after the 12 weeks intervention

    Pittsburgh Sleep Quality Index (PSQI) questionnaire, the outcome is a global PSQI score (range: 0-21), with higher scores indicating poorer sleep quality.

  14. Feelings of depression

    Time frame: before and after the 12 weeks intervention

    Patient Health Questionnaire (PHQ-9), the higher the score the more depressed a person is.

  15. Feelings of anxiety

    Time frame: before and after the 12 weeks intervention

    General Anxiety Disorder (GAD-7) questionnaire, the higher the score, the more anxious a person is.

  16. Plasma GABA concentration

    Time frame: before and after the 12 weeks intervention

  17. Plasma glutamate concentration

    Time frame: before and after the 12 weeks intervention

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Agrico Research
  • Avebe
  • Nunhems

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2020
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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