[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602520":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":38,"locations":47,"responsibleParty":65,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":29,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":29,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":98,"whyStopped":29,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"National University of Malaysia","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Crossover Arm 1 (Sucralose)","ACTIVE_COMPARATOR","Each participant will receive all three interventions, sucralose, saccharin, and placebo in a randomized sequence over three separate phases. Each intervention phase lasts for seven consecutive days and is separated by a washout period of 4 weeks to minimize carryover effects.",[13],"Dietary Supplement: Sucralose",{"label":15,"type":10,"description":11,"interventionNames":16},"Crossover Arm 2 (Saccharin)",[17],"Dietary Supplement: Saccharin",{"label":19,"type":20,"description":11,"interventionNames":21},"Crossover Arm 3 (Placebo)","PLACEBO_COMPARATOR",[22],"Other: Placebo (Calcium Carbonate)",[24,30,34],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DIETARY_SUPPLEMENT","Sucralose","Participants will consume one capsule containing sucralose 5mg\u002Fkg body weight, with the dosage individualized according to body weight. The capsule will be taken once daily in the morning, after breakfast, with plain water. This intervention will last for seven consecutive days.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Saccharin","Participants will consume one capsule containing saccharin 2mg\u002Fkg body weight, with the dosage individualized according to body weight. The capsule will be taken once daily in the morning, after breakfast, with plain water. This intervention will last for seven consecutive days.",[15],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Placebo (Calcium Carbonate)","Participants will consume one capsule per day, containing a fixed dose of 500 mg. The capsule will be taken once daily in the morning, after breakfast, with plain water. This intervention will last for seven consecutive days.",[19],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},"Harvinder Kaur, Phd","CONTACT","603 8921 5555","harvinder_kaur@ukm.edu.my",{"name":45,"role":41,"phone":29,"phoneExt":29,"email":46},"Huey Shin Tan","p153672@siswa.ukm.edu.my",[48],{"facility":49,"status":29,"city":50,"state":29,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Klinik Kesihatan Setapak","Kuala Lumpur","53300","Malaysia","MY",{"type":55,"coordinates":56},"Point",[57,58],101.68653,3.1412,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":63,"phoneExt":29,"email":64},"Medical Doctor","603 4142 4052","suhailinaim@gmail.com",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Harvinder Kaur A\u002FP Gilcharan Singh","Lecturer",[70],{"name":71,"class":6},"Monash University Malaysia","100602520","short-term-effects-of-sucralose-and-saccharin-on-blood-sugar-and-gut-microbiota-in-type-2-diabetes-100602520",false,"NCT07124585","Short-Term Effects of Sucralose and Saccharin on Blood Sugar and Gut Microbiota in Type 2 Diabetes","Short-Term Effect of Non-Nutritive Sweeteners (Sucralose and Saccharin) Consumption on Glycaemic Control and Gut Microbiota in Type 2 Diabetes Patients","Inclusion criteria This study aims to recruit a cohort of patients with early-phase diagnosed T2DM whose conditions are stable that can best represent the Malaysian DM phenotypes.\n\n1. Male citizens of Malaysia.\n2. Aged between 30 and 59 years.\n3. BMI between 23-29.9 kg\u002Fm² (Overweight).\n4. Diagnosed with diabetes for a duration between 1-10 years.\n5. Currently on oral antidiabetic medications and not on insulin.\n6. Initial HbA1c less than 10%.\n7. Patients with other stable, non-severe chronic conditions (e.g., hypertension, dyslipidemia) may be included if they have been on a stable prescribed oral treatment for at least 6 months.\n8. Patients who have undergone dietary counselling for diabetes and are willing to maintain their habitual diabetes-friendly diet and usual physical activity patterns throughout the study period.\n9. Willing to refrain from alcohol throughout the study period.\n10. Must be literate in English or Bahasa Malaysia.\n\nExclusion criteria The exclusion criteria will primarily focus on lifestyle behaviours or dietary practices that deviate from typical Malaysian lifestyles and while also considering behaviours that could significantly alter the gut microbiota.\n\n1. Current smoking, alcohol use, or drug abuse.\n2. Experienced more than a 5% change in body weight within the past 3 months.\n3. Acute illness or significant cardiovascular, psychological, neurological, renal, or endocrine diseases, apart from diabetes.\n4. Intolerance or allergy to test products.\n5. Special dietary practices (e.g., intermittent fasting, vegetarian, ketogenic diet) that deviate from typical Malaysian dietary patterns.\n6. Treatment with glucocorticoids, antibiotics or other medications and food supplements (e.g. probiotics) that can significantly alter intestinal function and gut microbiome.\n7. Involvement in clinical trials within the last 3 months.","MALE","30 Years","50 Years",{"count":83,"type":84},33,"ESTIMATED","INTERVENTIONAL",[87],"NA","This clinical trial investigates the short-term effects of two commonly used non-nutritive sweeteners (NNS), saccharin and sucralose, on blood glucose regulation and the gut microbiota in adults with Type 2 Diabetes Mellitus (T2DM). While NNS are widely promoted as sugar substitutes to aid glycaemic control, emerging evidence suggests that even small doses may influence metabolic health, potentially through interactions with the gut microbial community.\n\nThe study is designed as a double-blind, randomized, placebo-controlled, crossover trial involving 33 adults with T2DM. Each participant will receive all three interventions, saccharin, sucralose, and a placebo (calcium carbonate) in random order. Each intervention will be administered once daily in capsule form for 7 consecutive days, with a 4-week washout period between phases to minimize carryover effects.\n\nThroughout the trial, data will be collected on anthropometry, blood-based glycaemic biomarkers, dietary intake, physical activity, and stool samples. Gut microbiota composition will be assessed via 16S rRNA gene sequencing.\n\nThe primary aim is to generate evidence on whether short-term exposure to NNS can affect glycaemic outcomes and gut microbial profiles in individuals with T2DM. The findings are expected to support future dietary recommendations on NNS use and improve our understanding of diet-microbiota-host interactions, particularly within Asian populations.",[90],"Type 2 Diabetes Mellitus (T2DM)",[92,93,94,95,96,97],"Non-nutritive sweetener","artificial sweetener","gut microbiota","saccharin","sucralose","type 2 diabetes","NOT_YET_RECRUITING","2025-12-09",{"date":101,"type":102},"2025-12-10","ACTUAL",{"date":104,"type":84},"2026-01-30",{"date":106,"type":84},"2027-07-31",{"name":5,"class":6},1]