Type 2 Diabetes Mellitus (T2DM)NCT07124585
Short-Term Effects of Sucralose and Saccharin on Blood Sugar and Gut Microbiota in Type 2 Diabetes
A study testing Sucralose and Saccharin in people with Type 2 Diabetes Mellitus (T2DM), run by National University of Malaysia at 1 site in Malaysia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 50 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Sucralose and Saccharin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Jan 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- Men only
- No healthy volunteers
- Adult
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.
- Male citizens of Malaysia.
- Aged between 30 and 59 years.
- BMI between 23-29.9 kg/m² (Overweight).
- Diagnosed with diabetes for a duration between 1-10 years.
- Currently on oral antidiabetic medications and not on insulin.
- Initial HbA1c less than 10%.
- 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.
- 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.
- Willing to refrain from alcohol throughout the study period.
- Must be literate in English or Bahasa Malaysia.
Exclusion 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.
- Current smoking, alcohol use, or drug abuse.
- Experienced more than a 5% change in body weight within the past 3 months.
- Acute illness or significant cardiovascular, psychological, neurological, renal, or endocrine diseases, apart from diabetes.
- Intolerance or allergy to test products.
- Special dietary practices (e.g., intermittent fasting, vegetarian, ketogenic diet) that deviate from typical Malaysian dietary patterns.
- Treatment with glucocorticoids, antibiotics or other medications and food supplements (e.g. probiotics) that can significantly alter intestinal function and gut microbiome.
- Involvement in clinical trials within the last 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Huey Shin Tan contact
Malaysia1 site
Klinik Kesihatan Setapak
Kuala Lumpur, 53300
Medical Doctor, 603 4142 4052, suhailinaim@gmail.com
About this study
Official title: Short-Term Effect of Non-Nutritive Sweeteners (Sucralose and Saccharin) Consumption on Glycaemic Control and Gut Microbiota in Type 2 Diabetes Patients
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.
The 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.
Read more
Throughout 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.
The 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.
Read the detailed description
Although these sweeteners are generally recognized as safe, emerging studies have raised concerns regarding their potential metabolic effects. In particular, findings on their influence on glycaemic control in humans remain inconsistent. One proposed mechanism underlying these effects involves modulation of the gut microbiota, which is increasingly recognised as a critical regulator of host metabolic homeostasis. However, current evidence in human studies is limited and inconclusive.
Individuals with T2DM commonly exhibit pre-existing gut dysbiosis, raising important questions about whether the use of NNS may further impair microbial composition or function. To date, no clinical trial has comprehensively examined the short-term effects of sucralose and saccharin on both glycaemic responses and the gut microbiota in specific T2DM population. Moreover, data from Asian populations whose dietary patterns, gut microbial composition, and metabolic phenotypes differ significantly from Western cohorts are scarce. Given the widespread consumption of NNS in daily diets, especially among individuals seeking glycaemic control, this represents a critical evidence gap with potential implications for dietary recommendations and metabolic health.
This study aims to address these gaps through a clinical trial in adults with T2DM. The crossover design enables within-subject comparisons, thereby reducing inter-individual variability and enhancing statistical power to detect subtle biological effects. Reference to previous studies has shown inconsistencies arising from factors such as inconsistent dosing, varying administration routes (e.g., sachet vs. capsule; pure compound vs. commercial product), differences in intervention duration, and a lack of control for confounding variables such as habitual diet, medication use, and physical activity. To address these issues, we have incorporated several methodological improvements. Our study will implement a body weight-based individual dosing protocol, oral administration in a standardised pure compound capsule form, and detailed characterisation of participants' dietary intake and lifestyle behaviours.
Additionally, for our study phenotype, we have strictly controlled for patients' diabetes progression, including diagnosis duration (1-5 years), treatment type (oral antidiabetic medication only, no insulin), age group (30-50 years), demographic (male only), ethnicity (single ethnic group), and BMI range (specified). Through these measures, our study aims to minimise variability, particularly in gut microbiota outcomes and generate more robust results.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Sucralose, Saccharin, Placebo (Calcium Carbonate)
- Keywords
- Non-nutritive sweetener, artificial sweetener, gut microbiota, saccharin, sucralose, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucraloseDietary supplement
Participants will consume one capsule containing sucralose 5mg/kg 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.
SaccharinDietary supplement
Participants will consume one capsule containing saccharin 2mg/kg 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.
Placebo (Calcium Carbonate)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Sucralose |
| Crossover Arm 2 (Saccharin) | 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. Receives: Dietary Supplement: Saccharin |
| Crossover Arm 3 (Placebo) | Placebo 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. Receives: Other: Placebo (Calcium Carbonate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic control
The primary outcome of this study is to assess the change in glycaemic control, measured by insulin sensitivity using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), which will be calculated from fasting glucose and insulin levels following NNS consumption
Measured: 6 months
Secondary outcomes (1)
Gut microbiota composition and diversity
The secondary outcome is to evaluate changes in gut microbiota composition and diversity following NNS consumption. Microbiota outcomes will be assessed via 16S rRNA gene sequencing. Alpha diversity and beta diversity metrics will be used to evaluate within- and between-group microbiota differences. Differential abundance analysis will be conducted to identify specific taxanomy associated with each intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start30 Jan 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University Malaysia
- Responsible party
- Principal investigator, Harvinder Kaur A/P Gilcharan Singh, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124585
- Sponsor's protocol ID
- FRGS/1/2024/SKK06/UKM/03/4
- Status last verified
- Dec 2025
- First submitted
- 8 Aug 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual-level data including glycaemic parameters and gut microbiota profiles.
Publications
Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.
PubMed 25231862Serrano J, Smith KR, Crouch AL, Sharma V, Yi F, Vargova V, LaMoia TE, Dupont LM, Serna V, Tang F, Gomes-Dias L, Blakeslee JJ, Hatzakis E, Peterson SN, Anderson M, Pratley RE, Kyriazis GA. High-dose saccharin supplementation does not induce gut microbiota changes or glucose intolerance in healthy humans and mice. Microbiome. 2021 Jan 12;9(1):11. doi: 10.1186/s40168-020-00976-w.
PubMed 33431052Suez J, Cohen Y, Valdes-Mas R, Mor U, Dori-Bachash M, Federici S, Zmora N, Leshem A, Heinemann M, Linevsky R, Zur M, Ben-Zeev Brik R, Bukimer A, Eliyahu-Miller S, Metz A, Fischbein R, Sharov O, Malitsky S, Itkin M, Stettner N, Harmelin A, Shapiro H, Stein-Thoeringer CK, Segal E, Elinav E. Personalized microbiome-driven effects of non-nutritive sweeteners on human glucose tolerance. Cell. 2022 Sep 1;185(18):3307-3328.e19. doi: 10.1016/j.cell.2022.07.016. Epub 2022 Aug 19.
PubMed 35987213Ahmad SY, Friel J, Mackay D. The Effects of Non-Nutritive Artificial Sweeteners, Aspartame and Sucralose, on the Gut Microbiome in Healthy Adults: Secondary Outcomes of a Randomized Double-Blinded Crossover Clinical Trial. Nutrients. 2020 Nov 6;12(11):3408. doi: 10.3390/nu12113408.
PubMed 33171964Wu J, Wang K, Wang X, Pang Y, Jiang C. The role of the gut microbiome and its metabolites in metabolic diseases. Protein Cell. 2021 May;12(5):360-373. doi: 10.1007/s13238-020-00814-7. Epub 2020 Dec 21.
PubMed 33346905Brown RJ, de Banate MA, Rother KI. Artificial sweeteners: a systematic review of metabolic effects in youth. Int J Pediatr Obes. 2010 Aug;5(4):305-12. doi: 10.3109/17477160903497027.
PubMed 20078374Mendez-Garcia LA, Bueno-Hernandez N, Cid-Soto MA, De Leon KL, Mendoza-Martinez VM, Espinosa-Flores AJ, Carrero-Aguirre M, Esquivel-Velazquez M, Leon-Hernandez M, Viurcos-Sanabria R, Ruiz-Barranco A, Cota-Arce JM, Alvarez-Lee A, De Leon-Nava MA, Melendez G, Escobedo G. Ten-Week Sucralose Consumption Induces Gut Dysbiosis and Altered Glucose and Insulin Levels in Healthy Young Adults. Microorganisms. 2022 Feb 14;10(2):434. doi: 10.3390/microorganisms10020434.
PubMed 35208888Thomson P, Santibanez R, Aguirre C, Galgani JE, Garrido D. Short-term impact of sucralose consumption on the metabolic response and gut microbiome of healthy adults. Br J Nutr. 2019 Oct 28;122(8):856-862. doi: 10.1017/S0007114519001570. Epub 2019 Sep 13.
PubMed 31258108Zhou Z, Sun B, Yu D, Zhu C. Gut Microbiota: An Important Player in Type 2 Diabetes Mellitus. Front Cell Infect Microbiol. 2022 Feb 15;12:834485. doi: 10.3389/fcimb.2022.834485. eCollection 2022.
PubMed 35242721Toews I, Lohner S, Kullenberg de Gaudry D, Sommer H, Meerpohl JJ. Association between intake of non-sugar sweeteners and health outcomes: systematic review and meta-analyses of randomised and non-randomised controlled trials and observational studies. BMJ. 2019 Jan 2;364:k4718. doi: 10.1136/bmj.k4718.
PubMed 30602577Tan HS, Gilcharan Singh HK, Mariappan V, Jamil NA, Mustapa SN, Misra S. Short-Term Effects of Nonnutritive Sweetener (Sucralose and Saccharin) Consumption on Glycemic Control and Gut Microbiota in Patients With Type 2 Diabetes: Protocol for a Double-Blind, Randomized, Placebo-Controlled, Crossover Trial. JMIR Res Protoc. 2025 Dec 10;14:e82695. doi: 10.2196/82695.
PubMed 41370820
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effect of Non-Nutritive Sweeteners (Sucralose and Saccharin) Consumption on Glycaemic Control and Gut Microbiota in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT07124585
- Acronym / sponsor ID
- FRGS/1/2024/SKK06/UKM/03/4
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Non-nutritive sweetener, artificial sweetener, gut microbiota, saccharin, sucralose, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Monash University Malaysia
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 Aug 2025 (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.
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.
The 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.
Throughout 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.
The 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.
Detailed description
Although these sweeteners are generally recognized as safe, emerging studies have raised concerns regarding their potential metabolic effects. In particular, findings on their influence on glycaemic control in humans remain inconsistent. One proposed mechanism underlying these effects involves modulation of the gut microbiota, which is increasingly recognised as a critical regulator of host metabolic homeostasis. However, current evidence in human studies is limited and inconclusive.
Individuals with T2DM commonly exhibit pre-existing gut dysbiosis, raising important questions about whether the use of NNS may further impair microbial composition or function. To date, no clinical trial has comprehensively examined the short-term effects of sucralose and saccharin on both glycaemic responses and the gut microbiota in specific T2DM population. Moreover, data from Asian populations whose dietary patterns, gut microbial composition, and metabolic phenotypes differ significantly from Western cohorts are scarce. Given the widespread consumption of NNS in daily diets, especially among individuals seeking glycaemic control, this represents a critical evidence gap with potential implications for dietary recommendations and metabolic health.
This study aims to address these gaps through a clinical trial in adults with T2DM. The crossover design enables within-subject comparisons, thereby reducing inter-individual variability and enhancing statistical power to detect subtle biological effects. Reference to previous studies has shown inconsistencies arising from factors such as inconsistent dosing, varying administration routes (e.g., sachet vs. capsule; pure compound vs. commercial product), differences in intervention duration, and a lack of control for confounding variables such as habitual diet, medication use, and physical activity. To address these issues, we have incorporated several methodological improvements. Our study will implement a body weight-based individual dosing protocol, oral administration in a standardised pure compound capsule form, and detailed characterisation of participants' dietary intake and lifestyle behaviours.
Additionally, for our study phenotype, we have strictly controlled for patients' diabetes progression, including diagnosis duration (1-5 years), treatment type (oral antidiabetic medication only, no insulin), age group (30-50 years), demographic (male only), ethnicity (single ethnic group), and BMI range (specified). Through these measures, our study aims to minimise variability, particularly in gut microbiota outcomes and generate more robust results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crossover Arm 1 (Sucralose) | Active comparator | Dietary Supplement: SucraloseEach 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. |
| Crossover Arm 2 (Saccharin) | Active comparator | Dietary Supplement: SaccharinEach 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. |
| Crossover Arm 3 (Placebo) | Placebo comparator | Other: Placebo (Calcium Carbonate)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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| SucraloseParticipants will consume one capsule containing sucralose 5mg/kg 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. | Dietary supplement | Crossover Arm 1 (Sucralose) |
| SaccharinParticipants will consume one capsule containing saccharin 2mg/kg 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. | Dietary supplement | Crossover Arm 2 (Saccharin) |
| 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. | Other | Crossover Arm 3 (Placebo) |
Primary outcome
Glycaemic control
Time frame: 6 months
The primary outcome of this study is to assess the change in glycaemic control, measured by insulin sensitivity using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), which will be calculated from fasting glucose and insulin levels following NNS consumption
1 secondary outcome
Gut microbiota composition and diversity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 25231862Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.
- Results publication: PubMed 33431052Serrano J, Smith KR, Crouch AL, Sharma V, Yi F, Vargova V, LaMoia TE, Dupont LM, Serna V, Tang F, Gomes-Dias L, Blakeslee JJ, Hatzakis E, Peterson SN, Anderson M, Pratley RE, Kyriazis GA. High-dose saccharin supplementation does not induce gut microbiota changes or glucose intolerance in healthy humans and mice. Microbiome. 2021 Jan 12;9(1):11. doi: 10.1186/s40168-020-00976-w.
- Results publication: PubMed 35987213Suez J, Cohen Y, Valdes-Mas R, Mor U, Dori-Bachash M, Federici S, Zmora N, Leshem A, Heinemann M, Linevsky R, Zur M, Ben-Zeev Brik R, Bukimer A, Eliyahu-Miller S, Metz A, Fischbein R, Sharov O, Malitsky S, Itkin M, Stettner N, Harmelin A, Shapiro H, Stein-Thoeringer CK, Segal E, Elinav E. Personalized microbiome-driven effects of non-nutritive sweeteners on human glucose tolerance. Cell. 2022 Sep 1;185(18):3307-3328.e19. doi: 10.1016/j.cell.2022.07.016. Epub 2022 Aug 19.
- Results publication: PubMed 33171964Ahmad SY, Friel J, Mackay D. The Effects of Non-Nutritive Artificial Sweeteners, Aspartame and Sucralose, on the Gut Microbiome in Healthy Adults: Secondary Outcomes of a Randomized Double-Blinded Crossover Clinical Trial. Nutrients. 2020 Nov 6;12(11):3408. doi: 10.3390/nu12113408.
- Results publication: PubMed 33346905Wu J, Wang K, Wang X, Pang Y, Jiang C. The role of the gut microbiome and its metabolites in metabolic diseases. Protein Cell. 2021 May;12(5):360-373. doi: 10.1007/s13238-020-00814-7. Epub 2020 Dec 21.
- Results publication: PubMed 20078374Brown RJ, de Banate MA, Rother KI. Artificial sweeteners: a systematic review of metabolic effects in youth. Int J Pediatr Obes. 2010 Aug;5(4):305-12. doi: 10.3109/17477160903497027.
- Results publication: PubMed 35208888Mendez-Garcia LA, Bueno-Hernandez N, Cid-Soto MA, De Leon KL, Mendoza-Martinez VM, Espinosa-Flores AJ, Carrero-Aguirre M, Esquivel-Velazquez M, Leon-Hernandez M, Viurcos-Sanabria R, Ruiz-Barranco A, Cota-Arce JM, Alvarez-Lee A, De Leon-Nava MA, Melendez G, Escobedo G. Ten-Week Sucralose Consumption Induces Gut Dysbiosis and Altered Glucose and Insulin Levels in Healthy Young Adults. Microorganisms. 2022 Feb 14;10(2):434. doi: 10.3390/microorganisms10020434.
- Results publication: PubMed 31258108Thomson P, Santibanez R, Aguirre C, Galgani JE, Garrido D. Short-term impact of sucralose consumption on the metabolic response and gut microbiome of healthy adults. Br J Nutr. 2019 Oct 28;122(8):856-862. doi: 10.1017/S0007114519001570. Epub 2019 Sep 13.
- Results publication: PubMed 35242721Zhou Z, Sun B, Yu D, Zhu C. Gut Microbiota: An Important Player in Type 2 Diabetes Mellitus. Front Cell Infect Microbiol. 2022 Feb 15;12:834485. doi: 10.3389/fcimb.2022.834485. eCollection 2022.
- Results publication: PubMed 30602577Toews I, Lohner S, Kullenberg de Gaudry D, Sommer H, Meerpohl JJ. Association between intake of non-sugar sweeteners and health outcomes: systematic review and meta-analyses of randomised and non-randomised controlled trials and observational studies. BMJ. 2019 Jan 2;364:k4718. doi: 10.1136/bmj.k4718.
- Derived from this study: PubMed 41370820Tan HS, Gilcharan Singh HK, Mariappan V, Jamil NA, Mustapa SN, Misra S. Short-Term Effects of Nonnutritive Sweetener (Sucralose and Saccharin) Consumption on Glycemic Control and Gut Microbiota in Patients With Type 2 Diabetes: Protocol for a Double-Blind, Randomized, Placebo-Controlled, Crossover Trial. JMIR Res Protoc. 2025 Dec 10;14:e82695. doi: 10.2196/82695.
- Individual participant dataSharing planned: Yes. De-identified individual-level data including glycaemic parameters and gut microbiota profiles.
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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.
Huey Shin Tan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucralose and Saccharin in people with Type 2 Diabetes Mellitus (T2DM), run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 10 Dec 2025. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harvinder Kaur, Phd (603 8921 5555, harvinder_kaur@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic control (time frame: 6 months). 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 NCT07124585, which also lists 11 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 10 Dec 2025.