Glucose IntoleranceNARELONCT07194772
Sucralose and Glucose Metabolism in Young Healthy Adults
A study testing Low-calorie sweeteners (LCS), Refined sugars (SSB) and Natural sugars (FJ) in people with Glucose Intolerance and Glucose and Insulin Response, run by University of Ottawa at 1 site in Canada.
Trial summary
This study aimed to investigate the effects of a three-week consumption of sucralose-sweetened beverages (low-calorie sweetener) on postprandial glycemic responses in healthy adults, compared with sugar-sweetened beverages under real-world conditions. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Glucose and Insulin Response, Glucose Homeostasis
- What is being tested?
- Low-calorie sweeteners (LCS), Refined sugars (SSB) and Natural sugars (FJ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2022to 12 Jun 2024
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-35 y
- Body mass index (BMI) between 18.0 and 34.9 kg/m2
- Waist circumference < 102cm (men) and < 88cm (women)
- Self-reported stable weight during the prior 6 months (+ or - 2kg) of beginning the study.
- Additional Considerations related to the menstrual cycle and the use of hormonal contraceptives : All women who participated in this study were premenopausal. Recognizing the crucial importance of including women in our study while ensuring the highest quality data, additional considerations were applied to meet inclusion criteria:
- Women using no form of hormonal contraception or using copper intrauterine device (IUD) required to report having a regular menstrual cycle to be included
Show all 9Show fewer
- Women using anovulants (birth control pills) were advised to take their daily anovulant continuously for a period of 28 days to ensure stable hormone levels throughout the study (informed consent was obtained). Oral contraceptives release a low and stable daily amount of progestins, which were reported to have minor or no effects on glycemic responses of pre-menopausal women in a recent meta-analysis (Silva-Bermudez 2020).
- Women using hormonal contraception such as hormonal IUD and subdermal contraceptive implant were included regardless of their menstrual cycle. Like anovulants, hormonal IUD release a low and stable amount of a progestin (levonorgestrel) into the uterus, therefore preventing periodic fluctuations in hormonal levels during the menstrual cycle. Since Levonorgestrel was included as one of the progestins in the aforementioned meta-analysis, it was therefore assumed that HIUD would also not have a significant impact on glycemic responses, especially as its effect is local rather than systemic; Women using medroxyprogesterone acetate injections (Depo-Provera shot) were excluded given the pro-inflammatory effects associated with high doses of progestin
- Women experiencing pregnancy or lactation were excluded.
Who cannot join
- Prediabetes (fasting glucose ≥ 6.1 mmol/L)
- diabetes (fasting glucose ≥ 7.0 mmol/L)
- hypertension (> 140/90 mmHg)
- Reported medical history for dyslipidemias (including hypercholesterolemia and hypertriglyceridemia)
- Surgery for weight loss
- Individuals who smoke tobacco (including vaping), habitually ingest >2 alcoholic beverages/day and/or use cannabis or cannabis-derived products >1 time/month
Show all 9Show fewer
- Individuals who exercise >3.5 h/week at a level more vigorous than walking
- Individuals who use thyroid, lipid-lowering, glucose-lowering, antihypertensive, antidepressant/antianxiety, antibiotics in the prior 3 months or weight-loss medications
- Individuals susceptible to exhibit clinically relevant levels of food cravings as indicated by a score > 50 on the Food Cravings Questionnaire - Trait reduced (FCQ-T-r)36. FCQ-T-r (15 items) is a validated questionnaire37 that assesses four factors: (1) preoccupation with food (i.e., obsessive thought about food and eating), (2) loss of control (i.e., difficulty regulating eating behavior when exposed to food cues), (3) positive outcome expectancy (i.e., believing eating to be positively reinforcing), and (4) emotional craving (i.e., tending to crave food when experiencing negative emotion).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa
Ottawa, Ontario, K1S 5S9
About this study
Official title: The Effects of NAtural Sugars, REfined Sugars, and LOw-Calorie Sweeteners on Postprandial Glycemic Responses and Mechanistic Pathways Under Real-World Conditions
This study aimed to investigate the effects of a three-week consumption of sucralose-sweetened beverages (low-calorie sweetener) on postprandial glycemic responses in healthy adults, compared with sugar-sweetened beverages under real-world conditions. In brief, postprandial glycemic responses are used as an indicator of how your body manages blood sugar levels after consuming glucose. To explore potential mechanisms underlying any observed changes in postprandial glycemic responses, we further investigated potential alterations in gut microbiota composition and functionality, as well as plasmatic biomarkers of intestinal permeability and systemic low-grade inflammation. Finally, this project explored whether free sugars derived from a natural source (100% natural fruit juice) elicit metabolic responses that differ from those of refined sugars.
Participants visited the laboratory for a preliminary screening session to assess eligibility prior to being randomly assigned to one of the three experimental groups consuming either sucralose-sweetened beverages (LCS), sucrose-sweetened beverages (SSB), or 100% natural fruit juice (FJ) at dosage approximating real-world consumption over three weeks. Participants underwent two experimental sessions (duration of 3 hours each) at the beginning and completion of the study as outlined below.
Read the detailed description
PRELIMINARY SESSION (duration of 2h15) :
To determine eligibility, participants were asked to undergo a fasted in-person preliminary session during which the following measures were taken: height, weight, waist circumference, blood pressure, fasting blood glucose (using a glucometer with a capillary blood droplet collected on the fingertip) and answers to two food questionnaires related to dietary habits and food cravings. Upon confirmation of eligibility, participants were offered to continue the preliminary session and informed consent was obtained. Resting metabolic rate (used to determine daily energy needs) was measured using indirect calorimetry. To do so, participants wore a mask that covered their nose and mouth while lying down, awake and motionless for 30 minutes. Lastly, participants received essential information to prepare for their participation in the study. These included specific dietary instructions to follow during the 7-day pre-intervention period and for the duration of the study protocol as well as instructions on proper collection methods of stool samples at home. Specifically, a small quantity of stool samples (2 tubes of 10 mL each) was collected at the beginning and at the end of the study. Participants were asked to transport their frozen stool samples to our research facility at both of their experimental sessions using provided collection materials.
FIRST EXPERIMENTAL SESSION (duration of 3h00) :
The baseline experimental session was scheduled after a 7-day pre-intervention period, marking the beginning of the three-week study. Participants were asked to arrive at the laboratory around 7h30 AM following a 12-hour overnight fast, which began after consuming a standardized meal provided the evening before. Participants were asked to bring their first frozen stool sample (collected at home) to the laboratory as outlined above.
The following tests and procedures were performed :
- Body measurements: height, weight, and waist circumference were measured.
- Blood pressure: blood pressure was measured using an automatic sphygmomanometer, the same kind of equipment used by family physician.
- Body composition: body composition (bone density, lean and fat body mass) was measured using dual energy X-ray absorptiometry (DXA). Participants lied down on an examination table, fully clothed, while a low intensity X-ray scanned the entire body for the duration of five to ten minutes. The radiation level for each DXA scan is lower than the exposition during a transcontinental airplane flight.
- Oral glucose tolerance test (blood samples): An intravenous catheter was placed into the anti-cubital vein in the participants' forearm by certified personnel. This involves the insertion of a needle into a vein through which a small, flexible plastic tubing (catheter) is placed. The needle is then removed, leaving the tubing taped in place. This method allowed us to take blood draws throughout without the need for multiple venous punctures. A fasting 12mL blood sample was drawn immediately after insertion. Then, participants were given 5 minutes to drink a solution containing 75g of glucose. Blood draws of 12 mL each were collected at 30, 60, 90 and 120 min following the ingestion of the glucose solution. Plasma concentrations of glucose and insulin were measured to evaluate glucose homeostasis and insulin sensitivity. Plasmatic biomarkers of intestinal permeability and systemic low-grade inflammation were measured in fasting samples. A total of ~60mL of blood was collected for this procedure, which is a minimal amount. In comparison, a regular blood donation is around 470mL of blood. Participants drank water ad libitum throughout the session. A light snack was provided before the participant was sent home.
Study beverages :
Participants left the first experimental session with a one-week supply of study beverages corresponding to their randomly assigned group : sucralose-sweetened beverages (LCS), sucrose-sweetened beverages (SSB), or 100% natural fruit juice (FJ). Study beverages were designed to realistically reflect commercially available options, and the daily dose was personalized based on each participant's energy needs to simulate real-world intake. Study beverages were provided frozen in a cooler bag, and participants were instructed to consume one bottle per day (divided into three doses with meals) and to keep the bottles refrigerated. On weeks 2 and 3, participants returned to the laboratory to pick up their weekly supply and drop off used bottles (two visits total).
SECOND EXPERIMENTAL SESSION (duration of 3h00) :
A second experimental session was scheduled on day 22, that is after consuming study beverages for three weeks. The post-experimental sessions marked the end of the study. The same tests and procedures that occurred during the first experimental session were repeated.
TIMELINE SUMMARY :
- Preliminary session
- 7-day pre-intervention period
- Two small stool samples collected at home
- Day 0 : First experimental session including blood draws
- 21 days of consuming study beverages (two visits for pick-up and return of weekly supplies)
- Two small stool samples collected at home
- Day 22 : Second experimental session including blood draws
- Conditions
- Glucose Intolerance, Glucose and Insulin Response, Glucose Homeostasis, Low-grade Inflammation, Intestinal Permeability, Gut Microbiota Diversity and Composition
- Being tested
- Low-calorie sweeteners (LCS), Refined sugars (SSB), Natural sugars (FJ)
- Keywords
- low-calorie sweeteners, sucralose, natural sugars, fruit juice, refined sugars, sugar-sweetened beverages, LCS, SSB, non-nutritive sweeteners, sugar substitutes, gut microbiota, low-calorie sweeteners and gut microbiota, low-calorie sweeteners and glycemic responses, sucralose and gut microbiota, sucralose and glycemic responses
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-calorie sweeteners (LCS)Other
Consumption of sucralose-sweetened beverages (LCS) using doses and formulations reflecting real-world conditions.
Individualized dose equivalent volume (mL) to SSB group. Average dose received of 150 mg (±30 mg) of pure sucralose per day (2.00 ± 0.23 mg/Kg BW) among participants, which is below Acceptable Daily Intake for sucralose (5 mg/Kg BW/day). LCS matched for sweetness to SSB based on the manufacturer's information.
Refined sugars (SSB)Other
Consumption of sugar-sweetened beverages (SSB) using doses and formulations reflecting real-world conditions.
Individualized dose of 15% Ereq representing estimated free sugars consumption in Canada. SSB matched total free sugar concentration of 100% natural orange juice (FJ).
Natural sugars (FJ)Other
Consumption of natural fruit juice (100% natural orange juice) using doses and formulations reflecting real-world conditions.
Individualized dose of 15% Ereq representing estimated free sugars consumption in Canada.
| Study group | Role | What they receive |
|---|---|---|
| Sucralose-sweetened beverages (low-calorie sweetener) | Experimental | Not described Receives: Other: Low-calorie sweeteners (LCS) |
| Sugar-sweetened beverages (refined sugars) | Experimental | Not described Receives: Other: Refined sugars (SSB) |
| Natural fruit juice (natural sugars) | Experimental | 100% natural orange juice Receives: Other: Natural sugars (FJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Postprandial Glycemic Responses
Postprandial Glycemic Responses (plasma glucose concentrations) were assessed using a 2-hour 75g Oral Glucose Tolerance Test (OGTT) at baseline (day 0) and post-intervention (day 22)
Measured: 3 weeks
Secondary outcomes (5)
Change from Baseline in Postprandial Insulinemic Responses
Postprandial Insulinemic Responses (plasma insulin concentrations) were assessed using a 2-hour 75g Oral Glucose Tolerance Test (OGTT) at baseline (day 0) and post-intervention (day 22)
Measured: 3 weeks
Change from Baseline in Plasmatic Biomarkers of Intestinal Permeability
Plasmatic Biomarkers of Intestinal Permeability (Zonulin, LBP) were assessed in fasting plasma samples at baseline (day 0) and post-intervention (day 22)
Measured: 3 weeks
Change from Baseline in Plasmatic Biomarkers of Systemic Low-grade Inflammation
Plasmatic biomarkers of systemic low-grade inflammation (IL-6, TNF-a, CRP) were assessed in fasting plasma samples at baseline (day 0) and post-intervention (day 22)
Measured: 3 weeks
Change from Baseline in Fecal Concentrations of Short-Chain Fatty Acids and Branched-Chain Fatty Acids
Fecal Concentrations of Short-Chain Fatty Acids and Branched-Chain Fatty Acids were measured at baseline (day 0) and post-intervention (day 22). Two serial stool samples were collected on separate days within the three days preceding both the baseline and post-experimental sessions.
Measured: 3 weeks
Change from Baseline in Alpha-diversity and Beta-diversity of the Fecal Microbiota
Alpha-diversity and Beta-diversity of the Fecal Microbiota were measured at baseline (day 0) and post-intervention (day 22). Two serial stool samples were collected on separate days within the three days preceding both the baseline and post-experimental sessions.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start16 Mar 2022
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel-group design stratified by sex
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194772
- Sponsor's protocol ID
- H-04-20-5636
- Other IDs
- GR005077
- Acronym
- NARELO
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data that underlie the results reported in the publication, including participants characteristics, outcomes measures (i.e., glycemic-insulinemic responses, plasmatic biomarkers of intestinal permeability and low-grade inflammation as well as microbiota outcomes) and relevant covariates will be shared. Supporting documents such as the study protocol and statistical analysis plan will also be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of NAtural Sugars, REfined Sugars, and LOw-Calorie Sweeteners on Postprandial Glycemic Responses and Mechanistic Pathways Under Real-World Conditions
- ClinicalTrials.gov ID
- NCT07194772
- Acronym / sponsor ID
- NARELO / H-04-20-5636
- Conditions
- Glucose Intolerance, Glucose and Insulin Response, Glucose Homeostasis, Low-grade Inflammation, Intestinal Permeability, Gut Microbiota Diversity and Composition
- Keywords
- low-calorie sweeteners, sucralose, natural sugars, fruit juice, refined sugars, sugar-sweetened beverages, LCS, SSB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 26 Sep 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 study aimed to investigate the effects of a three-week consumption of sucralose-sweetened beverages (low-calorie sweetener) on postprandial glycemic responses in healthy adults, compared with sugar-sweetened beverages under real-world conditions. In brief, postprandial glycemic responses are used as an indicator of how your body manages blood sugar levels after consuming glucose. To explore potential mechanisms underlying any observed changes in postprandial glycemic responses, we further investigated potential alterations in gut microbiota composition and functionality, as well as plasmatic biomarkers of intestinal permeability and systemic low-grade inflammation. Finally, this project explored whether free sugars derived from a natural source (100% natural fruit juice) elicit metabolic responses that differ from those of refined sugars.
Participants visited the laboratory for a preliminary screening session to assess eligibility prior to being randomly assigned to one of the three experimental groups consuming either sucralose-sweetened beverages (LCS), sucrose-sweetened beverages (SSB), or 100% natural fruit juice (FJ) at dosage approximating real-world consumption over three weeks. Participants underwent two experimental sessions (duration of 3 hours each) at the beginning and completion of the study as outlined below.
Detailed description
PRELIMINARY SESSION (duration of 2h15) :
To determine eligibility, participants were asked to undergo a fasted in-person preliminary session during which the following measures were taken: height, weight, waist circumference, blood pressure, fasting blood glucose (using a glucometer with a capillary blood droplet collected on the fingertip) and answers to two food questionnaires related to dietary habits and food cravings. Upon confirmation of eligibility, participants were offered to continue the preliminary session and informed consent was obtained. Resting metabolic rate (used to determine daily energy needs) was measured using indirect calorimetry. To do so, participants wore a mask that covered their nose and mouth while lying down, awake and motionless for 30 minutes. Lastly, participants received essential information to prepare for their participation in the study. These included specific dietary instructions to follow during the 7-day pre-intervention period and for the duration of the study protocol as well as instructions on proper collection methods of stool samples at home. Specifically, a small quantity of stool samples (2 tubes of 10 mL each) was collected at the beginning and at the end of the study. Participants were asked to transport their frozen stool samples to our research facility at both of their experimental sessions using provided collection materials.
FIRST EXPERIMENTAL SESSION (duration of 3h00) :
The baseline experimental session was scheduled after a 7-day pre-intervention period, marking the beginning of the three-week study. Participants were asked to arrive at the laboratory around 7h30 AM following a 12-hour overnight fast, which began after consuming a standardized meal provided the evening before. Participants were asked to bring their first frozen stool sample (collected at home) to the laboratory as outlined above.
The following tests and procedures were performed :
- Body measurements: height, weight, and waist circumference were measured.
- Blood pressure: blood pressure was measured using an automatic sphygmomanometer, the same kind of equipment used by family physician.
- Body composition: body composition (bone density, lean and fat body mass) was measured using dual energy X-ray absorptiometry (DXA). Participants lied down on an examination table, fully clothed, while a low intensity X-ray scanned the entire body for the duration of five to ten minutes. The radiation level for each DXA scan is lower than the exposition during a transcontinental airplane flight.
- Oral glucose tolerance test (blood samples): An intravenous catheter was placed into the anti-cubital vein in the participants' forearm by certified personnel. This involves the insertion of a needle into a vein through which a small, flexible plastic tubing (catheter) is placed. The needle is then removed, leaving the tubing taped in place. This method allowed us to take blood draws throughout without the need for multiple venous punctures. A fasting 12mL blood sample was drawn immediately after insertion. Then, participants were given 5 minutes to drink a solution containing 75g of glucose. Blood draws of 12 mL each were collected at 30, 60, 90 and 120 min following the ingestion of the glucose solution. Plasma concentrations of glucose and insulin were measured to evaluate glucose homeostasis and insulin sensitivity. Plasmatic biomarkers of intestinal permeability and systemic low-grade inflammation were measured in fasting samples. A total of ~60mL of blood was collected for this procedure, which is a minimal amount. In comparison, a regular blood donation is around 470mL of blood. Participants drank water ad libitum throughout the session. A light snack was provided before the participant was sent home.
Study beverages :
Participants left the first experimental session with a one-week supply of study beverages corresponding to their randomly assigned group : sucralose-sweetened beverages (LCS), sucrose-sweetened beverages (SSB), or 100% natural fruit juice (FJ). Study beverages were designed to realistically reflect commercially available options, and the daily dose was personalized based on each participant's energy needs to simulate real-world intake. Study beverages were provided frozen in a cooler bag, and participants were instructed to consume one bottle per day (divided into three doses with meals) and to keep the bottles refrigerated. On weeks 2 and 3, participants returned to the laboratory to pick up their weekly supply and drop off used bottles (two visits total).
SECOND EXPERIMENTAL SESSION (duration of 3h00) :
A second experimental session was scheduled on day 22, that is after consuming study beverages for three weeks. The post-experimental sessions marked the end of the study. The same tests and procedures that occurred during the first experimental session were repeated.
TIMELINE SUMMARY :
- Preliminary session
- 7-day pre-intervention period
- Two small stool samples collected at home
- Day 0 : First experimental session including blood draws
- 21 days of consuming study beverages (two visits for pick-up and return of weekly supplies)
- Two small stool samples collected at home
- Day 22 : Second experimental session including blood draws
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized parallel-group design stratified by sex
| Arm | Type | Receives |
|---|---|---|
| Sucralose-sweetened beverages (low-calorie sweetener) | Experimental | Other: Low-calorie sweeteners (LCS) |
| Sugar-sweetened beverages (refined sugars) | Experimental | Other: Refined sugars (SSB) |
| Natural fruit juice (natural sugars) | Experimental | Other: Natural sugars (FJ)100% natural orange juice |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Ages 18-35 y
- Body mass index (BMI) between 18.0 and 34.9 kg/m2
- Waist circumference < 102cm (men) and < 88cm (women)
- Self-reported stable weight during the prior 6 months (+ or - 2kg) of beginning the study.
- Additional Considerations related to the menstrual cycle and the use of hormonal contraceptives : All women who participated in this study were premenopausal. Recognizing the crucial importance of including women in our study while ensuring the highest quality data, additional considerations were applied to meet inclusion criteria:
Key exclusion criteria (9 listed)
- Prediabetes (fasting glucose ≥ 6.1 mmol/L)
- diabetes (fasting glucose ≥ 7.0 mmol/L)
- hypertension (> 140/90 mmHg)
- Reported medical history for dyslipidemias (including hypercholesterolemia and hypertriglyceridemia)
- Surgery for weight loss
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 |
|---|---|---|
| Low-calorie sweeteners (LCS)Consumption of sucralose-sweetened beverages (LCS) using doses and formulations reflecting real-world conditions. Individualized dose equivalent volume (mL) to SSB group. Average dose received of 150 mg (±30 mg) of pure sucralose per day (2.00 ± 0.23 mg/Kg BW) among participants, which is below Acceptable Daily Intake for sucralose (5 mg/Kg BW/day). LCS matched for sweetness to SSB based on the manufacturer's information. | Other | Sucralose-sweetened beverages (low-calorie sweetener) |
| Refined sugars (SSB)Consumption of sugar-sweetened beverages (SSB) using doses and formulations reflecting real-world conditions. Individualized dose of 15% Ereq representing estimated free sugars consumption in Canada. SSB matched total free sugar concentration of 100% natural orange juice (FJ). | Other | Sugar-sweetened beverages (refined sugars) |
| Natural sugars (FJ)Consumption of natural fruit juice (100% natural orange juice) using doses and formulations reflecting real-world conditions. Individualized dose of 15% Ereq representing estimated free sugars consumption in Canada. | Other | Natural fruit juice (natural sugars) |
Primary outcome
Change from Baseline in Postprandial Glycemic Responses
Time frame: 3 weeks
Postprandial Glycemic Responses (plasma glucose concentrations) were assessed using a 2-hour 75g Oral Glucose Tolerance Test (OGTT) at baseline (day 0) and post-intervention (day 22)
5 secondary outcomes
Change from Baseline in Postprandial Insulinemic Responses
Time frame: 3 weeks
Change from Baseline in Plasmatic Biomarkers of Intestinal Permeability
Time frame: 3 weeks
Change from Baseline in Plasmatic Biomarkers of Systemic Low-grade Inflammation
Time frame: 3 weeks
Change from Baseline in Fecal Concentrations of Short-Chain Fatty Acids and Branched-Chain Fatty Acids
Time frame: 3 weeks
Change from Baseline in Alpha-diversity and Beta-diversity of the Fecal Microbiota
Time frame: 3 weeks
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 12 May 2026.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data that underlie the results reported in the publication, including participants characteristics, outcomes measures (i.e., glycemic-insulinemic responses, plasmatic biomarkers of intestinal permeability and low-grade inflammation as well as microbiota outcomes) and relevant covariates will be shared. Supporting documents such as the study protocol and statistical analysis plan will also be available upon request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-calorie sweeteners (LCS), Refined sugars (SSB) and Natural sugars (FJ) in people with Glucose Intolerance and Glucose and Insulin Response, run by University of Ottawa at 1 site in Canada.
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 9 inclusion and 9 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 12 May 2026. 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 Canada. 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. 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?
Change from Baseline in Postprandial Glycemic Responses (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.