PrediabetesNCT04303468
Intervention With a GABA Supplement in Prediabetics
A study testing GABA in people with Prediabetes and Hypertension, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Hypertension
- What is being tested?
- GABA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Sep 2020to 8 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen
About this study
Official title: The Effects of a GABA Supplement Versus a Placebo on Glucose Tolerance and Blood Pressure 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.
- Conditions
- Prediabetes, Hypertension
- Being tested
- GABA, Placebo
- Medical subject headings
- Prediabetic State, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GABADietary supplement
The dietary supplement GABA will be taken orally 3 times daily, before each main meal
PlaceboOther
Gelatin capsule containing powdered cellulose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: GABA |
| Placebo | Placebo comparator | The placebo consists of capsules containing powdered cellulose. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycaemic response during a 2 hour oral glucose tolerance test (OGTT)
A 2 hour oral glucose tolerance test with 75gr glucose
Measured: 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,
A 2 hour oral glucose tolerance test with 75gr glucose
Measured: blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention
Plasma free fatty acids
Measured: before and after the 12 weeks intervention
HbA1c
Measured: before and after the 12 weeks intervention
Glucose variability
The participants wear a flash glucose monitoring sensor with which their interstitial glucose is measured every 15 minutes.
Measured: 5 days during which they eat their habitual diet, before and after the 12 weeks intervention
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
Measured: Dynamic measurement: 24 hours, before and after the 12 weeks intervention
Heart rate
Measured: before and after the 12 weeks intervention
Concentrion of markers of inflammation in blood
C-reactive protein and cytokines like IL-6 and TNF-alpha
Measured: before and after the 12 weeks intervention
Concentration of triglycerides in blood
Measured: before and after the 12 weeks intervention
Concentration of LDL and HDL cholesterol in blood
Measured: before and after the 12 weeks intervention
Concentration of ALAT and ASAT in blood
Measured: before and after the 12 weeks intervention
Acute effects of GABA on postprandial glucose
Assessed with an OGTT during which interstitial glucose is measured with flash glucose monitoring
Measured: 2 hours, after a single administration of 500 mg GABA
Acute effects of GABA on blood pressure
Assessed with an ambulatory blood pressure monitor
Measured: for 24 hours during which GABA is taken 3 times, each time before the main meal
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.
Measured: before and after the 12 weeks intervention
Feelings of depression
Patient Health Questionnaire (PHQ-9), the higher the score the more depressed a person is.
Measured: before and after the 12 weeks intervention
Feelings of anxiety
General Anxiety Disorder (GAD-7) questionnaire, the higher the score, the more anxious a person is.
Measured: before and after the 12 weeks intervention
Plasma GABA concentration
Measured: before and after the 12 weeks intervention
Plasma glutamate concentration
Measured: before and after the 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start29 Sep 2020
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo controlled double blind parallel study design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Nunhems, Agrico Research, Avebe
- Responsible party
- Sponsor
- Investigators
- Renger Witkamp, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303468
- Sponsor's protocol ID
- NL73194.081.20
- Status last verified
- Nov 2021
- First submitted
- 4 Mar 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37495019de 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.
PubMed 35852458
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a GABA Supplement Versus a Placebo on Glucose Tolerance and Blood Pressure in Prediabetics
- ClinicalTrials.gov ID
- NCT04303468
- Acronym / sponsor ID
- NL73194.081.20
- Conditions
- Prediabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Nunhems, Agrico Research, Avebe
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo controlled double blind parallel study design
| Arm | Type | Receives |
|---|---|---|
| GABA | Experimental | Dietary Supplement: GABAGABA 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 |
| Placebo | Placebo comparator | Other: PlaceboThe placebo consists of capsules containing powdered cellulose. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GABAThe dietary supplement GABA will be taken orally 3 times daily, before each main meal | Dietary supplement | GABA |
| PlaceboGelatin capsule containing powdered cellulose | Other | Placebo |
Primary outcome
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
17 secondary outcomes
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
Plasma free fatty acids
Time frame: before and after the 12 weeks intervention
HbA1c
Time frame: before and after the 12 weeks intervention
Glucose variability
Time frame: 5 days during which they eat their habitual diet, before and after the 12 weeks intervention
Blood pressure
Time frame: Dynamic measurement: 24 hours, before and after the 12 weeks intervention
Heart rate
Time frame: before and after the 12 weeks intervention
Concentrion of markers of inflammation in blood
Time frame: before and after the 12 weeks intervention
Concentration of triglycerides in blood
Time frame: before and after the 12 weeks intervention
Concentration of LDL and HDL cholesterol in blood
Time frame: before and after the 12 weeks intervention
Concentration of ALAT and ASAT in blood
Time frame: before and after the 12 weeks intervention
Acute effects of GABA on postprandial glucose
Time frame: 2 hours, after a single administration of 500 mg GABA
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
Sleep quality
Time frame: before and after the 12 weeks intervention
Feelings of depression
Time frame: before and after the 12 weeks intervention
Feelings of anxiety
Time frame: before and after the 12 weeks intervention
Plasma GABA concentration
Time frame: before and after the 12 weeks intervention
Plasma glutamate concentration
Time frame: before and after the 12 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Derived from this study: PubMed 37495019de 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.
- Derived from this study: PubMed 35852458de 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.
- Individual participant dataSharing planned: Undecided
Related trials for Prediabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruitingEarly Phase 1
Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia
Hyperglycemias, Prediabetes
Recruiting
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Overweight , Obesity, Prediabetes
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renger Witkamp, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GABA in people with Prediabetes and Hypertension, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04303468, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.