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| Name | Class |
|---|---|
| Nunhems | UNKNOWN |
| Agrico Research | UNKNOWN |
| Avebe | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | The placebo consists of capsules containing powdered cellulose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GABA | Dietary Supplement | The dietary supplement GABA will be taken orally 3 times daily, before each main meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma free fatty acids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renger Witkamp, PhD | Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University, Division of Human Nutrition | Wageningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37495019 | Derived | 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. | |
| 35852458 | Derived |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| ID | Term |
|---|---|
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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Randomized placebo controlled double blind parallel study design
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| Placebo | Other | Gelatin capsule containing powdered cellulose |
|
| before and after the 12 weeks intervention |
| HbA1c | 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. | 5 days during which they eat their habitual diet, before and after the 12 weeks intervention |
| Blood pressure | Single measurement and a dynamic measurement:
| Dynamic measurement: 24 hours, before and after the 12 weeks intervention |
| Heart rate | 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 | before and after the 12 weeks intervention |
| Concentration of triglycerides in blood | before and after the 12 weeks intervention |
| Concentration of LDL and HDL cholesterol in blood | before and after the 12 weeks intervention |
| Concentration of ALAT and ASAT in blood | 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 | 2 hours, after a single administration of 500 mg GABA |
| 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 |
| 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 |
| 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 |
| 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 |
| Plasma GABA concentration | before and after the 12 weeks intervention |
| Plasma glutamate concentration | before and after the 12 weeks intervention |
| 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. |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |