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Intervention With a GABA Supplement in Prediabetics

NCT ID: NCT04303468

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2021-09-08

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo controlled double blind parallel study design
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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GABA

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

Group Type EXPERIMENTAL

GABA

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

The placebo consists of capsules containing powdered cellulose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Gelatin capsule containing powdered cellulose

Interventions

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GABA

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Gelatin capsule containing powdered cellulose

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nunhems

UNKNOWN

Sponsor Role collaborator

Agrico Research

UNKNOWN

Sponsor Role collaborator

Avebe

UNKNOWN

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renger Witkamp, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Wageningen University, Division of Human Nutrition

Wageningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 37495019 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35852458 (View on PubMed)

Other Identifiers

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NL73194.081.20

Identifier Type: -

Identifier Source: org_study_id