Intervention With a GABA Supplement in Prediabetics

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303468
• Other study ID #: NL73194.081.20
• Status: Completed
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: September 8, 2021

Study information

• Verified date: November 2021
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Prediabetes
• Prediabetic State

Intervention

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

Other:
• Placebo
Gelatin capsule containing powdered cellulose

Locations

Country	Name	City	State
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen

Sponsors (4)

Lead Sponsor	Collaborator
Wageningen University	Agrico Research, Avebe, Nunhems

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycaemic response during a 2 hour oral glucose tolerance test (OGTT)	A 2 hour oral glucose tolerance test with 75gr glucose	blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention
Secondary	Postprandial insulin and glucagon response during a 2 hour OGTT,	A 2 hour oral glucose tolerance test with 75gr glucose	blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention
Secondary	Plasma free fatty acids		before and after the 12 weeks intervention
Secondary	HbA1c		before and after the 12 weeks intervention
Secondary	Glucose variability	The participants wear a flash glucose monitoring sensor with which their interstitial glucose is measured every 15 minutes.	5 days during which they eat their habitual diet, before and after the 12 weeks intervention
Secondary	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	Dynamic measurement: 24 hours, before and after the 12 weeks intervention
Secondary	Heart rate		before and after the 12 weeks intervention
Secondary	Concentrion of markers of inflammation in blood	C-reactive protein and cytokines like IL-6 and TNF-alpha	before and after the 12 weeks intervention
Secondary	Concentration of triglycerides in blood		before and after the 12 weeks intervention
Secondary	Concentration of LDL and HDL cholesterol in blood		before and after the 12 weeks intervention
Secondary	Concentration of ALAT and ASAT in blood		before and after the 12 weeks intervention
Secondary	Acute effects of GABA on postprandial glucose	Assessed with an OGTT during which interstitial glucose is measured with flash glucose monitoring	2 hours, after a single administration of 500 mg GABA
Secondary	Acute effects of GABA on blood pressure	Assessed with an ambulatory blood pressure monitor	for 24 hours during which GABA is taken 3 times, each time before the main meal
Secondary	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.	before and after the 12 weeks intervention
Secondary	Feelings of depression	Patient Health Questionnaire (PHQ-9), the higher the score the more depressed a person is.	before and after the 12 weeks intervention
Secondary	Feelings of anxiety	General Anxiety Disorder (GAD-7) questionnaire, the higher the score, the more anxious a person is.	before and after the 12 weeks intervention
Secondary	Plasma GABA concentration		before and after the 12 weeks intervention
Secondary	Plasma glutamate concentration		before and after the 12 weeks intervention