Glucose IntoleranceNCT03708939
Microbiome and Non-caloric Sweeteners in Humans
A study testing Glucose, Aspartame and Sucralose in people with Glucose Intolerance and Glucose, Low Blood, run by Weizmann Institute of Science at 1 site in Israel.
Trial summary
Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Glucose, Low Blood, Glucose, High Blood
- What is being tested?
- Glucose, Aspartame and Sucralose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Feb 2017to 1 Jan 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI<28
- Age - 18-70
- Capable of working with smartphone application
- Capable to work with a glucometer
Who cannot join
- Consumption of antibitioics 3 months prior to the first day of the experiment.
- Consumption of Non caloric sweetners 6 months prior to the first day of the experiment.
- Diagnosis with type 1 or type 2 diabetes.
- Pregnancy, fertility treatments
- Breastfeeding (Including baby to breast and bottle feeding expressed breast milk)
- Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
Show all 14Show fewer
- Cancer and recent anticancer treatment
- Psychiatric disorders
- Coagulation disorders
- IBD (inflammatory bowel diseases)
- Bariatric surgery
- Alcohol or substance abuse
- BMI>28
- Aspartame group only: phenylketonuria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners
Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. While they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. The investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. The proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.
- Conditions
- Glucose Intolerance, Glucose, Low Blood, Glucose, High Blood
- Being tested
- Glucose, Aspartame, Sucralose, Saccharin, Stevia
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseDietary supplement
Daily consumption of 5g of glucose, for 14 days.
AspartameDietary supplement
Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.
SucraloseDietary supplement
Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.
SaccharinDietary supplement
Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.
SteviaDietary supplement
Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.
No SupplementOther
Follow up without any dietary supplementation.
| Study group | Role | What they receive |
|---|---|---|
| glucose | Experimental | Not described Receives: Dietary Supplement: Glucose |
| aspartame | Experimental | Not described Receives: Dietary Supplement: Aspartame |
| sucralose | Experimental | Not described Receives: Dietary Supplement: Sucralose |
| saccharin | Experimental | Not described Receives: Dietary Supplement: Saccharin |
| Stevia | Experimental | Not described Receives: Dietary Supplement: Stevia |
| No supplement control | Experimental | Not described Receives: Other: No Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
Continuous glucose monitor device
Measured: 28 days
Secondary outcomes (1)
Microbiome
Stool and oral samples
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start19 Feb 2017
- Primary completion1 Aug 2020
- Study completion1 Jan 2021
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eran Elinav, Weizmann Institute of Science
- Investigators
- Eran Elinav, Principal investigator, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708939
- Sponsor's protocol ID
- 170-2
- Status last verified
- Aug 2021
- First submitted
- 14 Oct 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners
- ClinicalTrials.gov ID
- NCT03708939
- Acronym / sponsor ID
- 170-2
- Conditions
- Glucose Intolerance, Glucose, Low Blood, Glucose, High Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Weizmann Institute of ScienceUniversity, hospital or other
- Study start
- 19 Feb 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 17 Oct 2018 (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.
Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. While they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. The investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. The proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| glucose | Experimental | Dietary Supplement: Glucose |
| aspartame | Experimental | Dietary Supplement: Aspartame |
| sucralose | Experimental | Dietary Supplement: Sucralose |
| saccharin | Experimental | Dietary Supplement: Saccharin |
| Stevia | Experimental | Dietary Supplement: Stevia |
| No supplement control | Experimental | Other: No Supplement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI<28
- Age - 18-70
- Capable of working with smartphone application
- Capable to work with a glucometer
Key exclusion criteria (14 listed)
- Consumption of antibitioics 3 months prior to the first day of the experiment.
- Consumption of Non caloric sweetners 6 months prior to the first day of the experiment.
- Diagnosis with type 1 or type 2 diabetes.
- Pregnancy, fertility treatments
- Breastfeeding (Including baby to breast and bottle feeding expressed breast milk)
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 |
|---|---|---|
| GlucoseDaily consumption of 5g of glucose, for 14 days. | Dietary supplement | glucose |
| AspartameDaily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days. | Dietary supplement | aspartame |
| SucraloseDaily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days. | Dietary supplement | sucralose |
| SaccharinDaily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days. | Dietary supplement | saccharin |
| SteviaDaily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days. | Dietary supplement | Stevia |
| No SupplementFollow up without any dietary supplementation. | Other | No supplement control |
Primary outcome
Blood glucose level
Time frame: 28 days
Continuous glucose monitor device
1 secondary outcome
Microbiome
Time frame: 28 days
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 4 Aug 2021.
Related trials for Glucose Intolerance
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
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.
Eran Elinav principal investigator
Weizmann Institute of Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose, Aspartame and Sucralose in people with Glucose Intolerance and Glucose, Low Blood, run by Weizmann Institute of Science at 1 site in Israel.
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 4 inclusion and 14 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 4 Aug 2021. 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 Israel. 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?
Blood glucose level (time frame: 28 days). 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 4 Aug 2021.