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Intervention With a GABA Supplement in Prediabetics

Primary Purpose

Prediabetes, Hypertension

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

GABA

Placebo

About this trial

This is an interventional prevention trial for Prediabetes

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Wageningen University, Division of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GABA

Placebo

Arm 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

The placebo consists of capsules containing powdered cellulose.

Outcomes

Primary Outcome Measures

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

A 2 hour oral glucose tolerance test with 75gr glucose

Secondary Outcome Measures

Postprandial insulin and glucagon response during a 2 hour OGTT,

A 2 hour oral glucose tolerance test with 75gr glucose

Plasma free fatty acids

HbA1c

Glucose variability

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

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

Heart rate

Concentrion of markers of inflammation in blood

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

Concentration of triglycerides in blood

Concentration of LDL and HDL cholesterol in blood

Concentration of ALAT and ASAT in blood

Acute effects of GABA on postprandial glucose

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

Acute effects of GABA on blood pressure

Assessed with an ambulatory blood pressure monitor

Sleep quality

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

Feelings of depression

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

Feelings of anxiety

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

Plasma GABA concentration

Plasma glutamate concentration

Full Information

NCT ID

NCT04303468

First Posted

March 4, 2020

Last Updated

November 15, 2021

Sponsor

Wageningen University

Collaborators

Nunhems, Agrico Research, Avebe

1. Study Identification

Unique Protocol Identification Number

NCT04303468

Brief Title

Intervention With a GABA Supplement in Prediabetics

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

September 29, 2020 (Actual)

Primary Completion Date

September 8, 2021 (Actual)

Study Completion Date

September 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wageningen University

Collaborators

Nunhems, Agrico Research, Avebe

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 will be assessed in prediabetics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes, Hypertension

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized placebo controlled double blind parallel study design

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GABA

Arm Type

Experimental

Arm 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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The placebo consists of capsules containing powdered cellulose.

Intervention Type

Dietary Supplement

Intervention Name(s)

GABA

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Gelatin capsule containing powdered cellulose

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Postprandial insulin and glucagon response during a 2 hour OGTT,

Description

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

Title

Plasma free fatty acids

Time Frame

before and after the 12 weeks intervention

Title

HbA1c

Time Frame

before and after the 12 weeks intervention

Title

Glucose variability

Description

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

Title

Blood pressure

Description

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

Title

Heart rate

Time Frame

before and after the 12 weeks intervention

Title

Concentrion of markers of inflammation in blood

Description

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

Time Frame

before and after the 12 weeks intervention

Title

Concentration of triglycerides in blood

Time Frame

before and after the 12 weeks intervention

Title

Concentration of LDL and HDL cholesterol in blood

Time Frame

before and after the 12 weeks intervention

Title

Concentration of ALAT and ASAT in blood

Time Frame

before and after the 12 weeks intervention

Title

Acute effects of GABA on postprandial glucose

Description

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

Time Frame

2 hours, after a single administration of 500 mg GABA

Title

Acute effects of GABA on blood pressure

Description

Assessed with an ambulatory blood pressure monitor

Time Frame

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

Title

Sleep quality

Description

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

Time Frame

before and after the 12 weeks intervention

Title

Feelings of depression

Description

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

Time Frame

before and after the 12 weeks intervention

Title

Feelings of anxiety

Description

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

Time Frame

before and after the 12 weeks intervention

Title

Plasma GABA concentration

Time Frame

before and after the 12 weeks intervention

Title

Plasma glutamate concentration

Time Frame

before and after the 12 weeks intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renger Witkamp, PhD

Organizational Affiliation

Wageningen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wageningen University, Division of Human Nutrition

City

Wageningen

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35852458

Citation

de Bie TH, Balvers MGJ, de Vos RCH, Witkamp RF, Jongsma MA. The influence of a tomato food matrix on the bioavailability and plasma kinetics of oral gamma-aminobutyric acid (GABA) and its precursor glutamate in healthy men. Food Funct. 2022 Aug 15;13(16):8399-8410. doi: 10.1039/d2fo01358d.

Results Reference

derived

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Intervention With a GABA Supplement in Prediabetics

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