Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-02 @ 2:40 AM
Study NCT ID:
NCT04303468
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2020-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention With a GABA Supplement in Prediabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}], 'ancestors': [{'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo controlled double blind parallel study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial glycaemic response during a 2 hour oral glucose tolerance test (OGTT)', 'timeFrame': 'blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention', 'description': 'A 2 hour oral glucose tolerance test with 75gr glucose'}], 'secondaryOutcomes': [{'measure': 'Postprandial insulin and glucagon response during a 2 hour OGTT,', 'timeFrame': 'blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention', 'description': 'A 2 hour oral glucose tolerance test with 75gr glucose'}, {'measure': 'Plasma free fatty acids', 'timeFrame': 'before and after the 12 weeks intervention'}, {'measure': 'HbA1c', 'timeFrame': 'before and after the 12 weeks intervention'}, {'measure': 'Glucose variability', 'timeFrame': '5 days during which they eat their habitual diet, before and after the 12 weeks intervention', 'description': 'The participants wear a flash glucose monitoring sensor with which their interstitial glucose is measured every 15 minutes.'}, {'measure': 'Blood pressure', 'timeFrame': 'Dynamic measurement: 24 hours, before and after the 12 weeks intervention', 'description': 'Single measurement and a dynamic measurement:\n\n* Mean day systolic and diastolic blood pressure\n* Mean night systolic and diastolic blood pressure\n* Time below or above 120/80 mmHg'}, {'measure': 'Heart rate', 'timeFrame': 'before and after the 12 weeks intervention'}, {'measure': 'Concentrion of markers of inflammation in blood', 'timeFrame': 'before and after the 12 weeks intervention', 'description': 'C-reactive protein and cytokines like IL-6 and TNF-alpha'}, {'measure': 'Concentration of triglycerides in blood', 'timeFrame': 'before and after the 12 weeks intervention'}, {'measure': 'Concentration of LDL and HDL cholesterol in blood', 'timeFrame': 'before and after the 12 weeks intervention'}, {'measure': 'Concentration of ALAT and ASAT in blood', 'timeFrame': 'before and after the 12 weeks intervention'}, {'measure': 'Acute effects of GABA on postprandial glucose', 'timeFrame': '2 hours, after a single administration of 500 mg GABA', 'description': 'Assessed with an OGTT during which interstitial glucose is measured with flash glucose monitoring'}, {'measure': 'Acute effects of GABA on blood pressure', 'timeFrame': 'for 24 hours during which GABA is taken 3 times, each time before the main meal', 'description': 'Assessed with an ambulatory blood pressure monitor'}, {'measure': 'Sleep quality', 'timeFrame': 'before and after the 12 weeks intervention', 'description': 'Pittsburgh Sleep Quality Index (PSQI) questionnaire, the outcome is a global PSQI score (range: 0-21), with higher scores indicating poorer sleep quality.'}, {'measure': 'Feelings of depression', 'timeFrame': 'before and after the 12 weeks intervention', 'description': 'Patient Health Questionnaire (PHQ-9), the higher the score the more depressed a person is.'}, {'measure': 'Feelings of anxiety', 'timeFrame': 'before and after the 12 weeks intervention', 'description': 'General Anxiety Disorder (GAD-7) questionnaire, the higher the score, the more anxious a person is.'}, {'measure': 'Plasma GABA concentration', 'timeFrame': 'before and after the 12 weeks intervention'}, {'measure': 'Plasma glutamate concentration', 'timeFrame': 'before and after the 12 weeks intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prediabetes', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '37495019', 'type': 'DERIVED', 'citation': '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': '35852458', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 50 and 70\n* BMI higher or equal to 27 kg/m2\n* Impaired fasting glucose (fasting glucose ≥ 6.1 and ≤ 6.9 mmol/L) or/and\n* 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)\n\nExclusion Criteria:\n\n* Has been diagnosed with diabetes\n* Having other conditions, like liver, pancreatic, cardiovascular, gastro-intestinal or endocrine diseases, that could influence the study results\n* Use of medications or supplements that could influence the study results\n* Sensitive to medical skin adhesives\n* More than 5kg weight change in the past 12 weeks\n* Excessive alcohol consumption (\\>21 glasses/week for men and \\>14 glasses/week for women on average)\n* Being an employee of Wageningen University, division Human Nutrition and Health\n* Currently a research subject in other research'}, 'identificationModule': {'nctId': 'NCT04303468', 'briefTitle': 'Intervention With a GABA Supplement in Prediabetics', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Effects of a GABA Supplement Versus a Placebo on Glucose Tolerance and Blood Pressure in Prediabetics', 'orgStudyIdInfo': {'id': 'NL73194.081.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GABA', 'description': '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', 'interventionNames': ['Dietary Supplement: GABA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo consists of capsules containing powdered cellulose.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'GABA', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The dietary supplement GABA will be taken orally 3 times daily, before each main meal', 'armGroupLabels': ['GABA']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Gelatin capsule containing powdered cellulose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wageningen', 'country': 'Netherlands', 'facility': 'Wageningen University, Division of Human Nutrition', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Renger Witkamp, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nunhems', 'class': 'UNKNOWN'}, {'name': 'Agrico Research', 'class': 'UNKNOWN'}, {'name': 'Avebe', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}