NCT04303468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

March 4, 2020

Last Update Submit

November 15, 2021

Conditions

PrediabetesHypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Postprandial insulin and glucagon response during a 2 hour OGTT,

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

  • Plasma free fatty acids

    before and after the 12 weeks intervention

  • HbA1c

    before and after the 12 weeks intervention

  • Glucose variability

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

  • Blood pressure

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

  • +12 more secondary outcomes

Study Arms (2)

GABA

EXPERIMENTAL

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

Dietary Supplement: GABA

Placebo

PLACEBO COMPARATOR

The placebo consists of capsules containing powdered cellulose.

Other: Placebo

Interventions

GABADIETARY_SUPPLEMENT

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

GABA
PlaceboOTHER

Gelatin capsule containing powdered cellulose

Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Netherlands

Location

Related Publications (2)

  • de Bie TH, Witkamp RF, Balvers MG, Jongsma MA. Effects of gamma-aminobutyric acid supplementation on glucose control in adults with prediabetes: A double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2023 Sep;118(3):708-719. doi: 10.1016/j.ajcnut.2023.07.017. Epub 2023 Jul 24.

    PMID: 37495019DERIVED

  • 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.

    PMID: 35852458DERIVED

MeSH Terms

Conditions

Prediabetic StateHypertension

Interventions

gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Renger Witkamp, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized placebo controlled double blind parallel study design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 11, 2020

Study Start

September 29, 2020

Primary Completion

September 8, 2021

Study Completion

September 8, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations

NL(1)