HealthyNCT05264636
The Impact of Steviol Glycosides on Human Gut Microflora Profile and Function
A study testing Sucrose and Steviol Glycosides in people with Healthy and Human Gut Microflora, run by Cargill at 1 site in Canada.
Trial summary
Diet and dietary ingredients can have a profound effect on gut microflora, both positive and negative. The reported effects on low and non caloric sweeteners (LNCS) on human gut microflora are contradictory in some of the in vitro and rodent studies. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Human Gut Microflora
- What is being tested?
- Sucrose and Steviol Glycosides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2022to 29 Aug 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Non-pregnant, non-lactating individuals at least 25 of whom are male and 25 female
- Aged 18-50 years, inclusive
- BMI 18.5 to 24.9, inclusive
- Has access to a phone or tablet and wifi (to complete app based 3DDR)
- Consumption of ≤600ml (20oz) high intensity sweetened beverages per week for 1 month before screening
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- Normal bowel frequency (≥3 per week)
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study Principal investigator
- Willing to not significantly alter their normal diet, physical activity routine, fiber intake or consume prebiotics or probiotics during the 8-week treatment period.
- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
Who cannot join
- Failure to meet any one of the inclusion criteria
- Use of prebiotic or probiotic supplement one month prior to the study and during the entire duration of the study
- Smokers (cigarettes, vape or marijuana)
- Habitual consumption of >1.5L sugar sweetened beverages (eg. juice, soft drinks) per day
- High alcohol consumption (>14 drinks per week and >4 drinks per day for males; and >7 drinks per week and >3 drinks per day for females), or history of alcohol abuse. Alcohol intake during the study must stay below these limits listed above
- History of major trauma or major medical or surgical event requiring hospitalization within 3 months of screening
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- Individuals with diabetes, bariatric surgery, celiac disease, phenylketonuria, inflammatory bowel disease, moderate or severe renal failure, moderate or severe liver disease or any other medical conditions or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator
- Use of antibiotics within 3 months of screening or with a condition likely to require the use of antibiotics during the study
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
- Known intolerance, sensitivity, or allergy to any ingredients in the study test beverages.
- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.
- Reported weight change of > 5kg in the preceding 3 months
- Employed by the study sponsor or affiliated organizations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a 28-day Steviol Glycoside Beverage on Human Gut Microflora Profile and Function vs. a Sucrose Beverage in Healthy Adults
Diet and dietary ingredients can have a profound effect on gut microflora, both positive and negative. The reported effects on low and non caloric sweeteners (LNCS) on human gut microflora are contradictory in some of the in vitro and rodent studies. More specifically, the latter studies, using doses above the acceptable daily intake (ADI), suggest that LNCS may have adverse effects on gut microflora whereas recent data from human RCTs, using doses at or below the ADI, show little to no effect. In this study we will compare the effects of a low energy beverage made with steviol glycosides vs. a beverage made with sucrose on human gut microflora profile and function in a double blind, randomized study. A sucrose beverage was chosen as a control as it represents a caloric sugar sweetened beverage which is commonly consumed.
Read the detailed description
This is a double blind randomized parallel study with 2 treatments to understand the effects of a low energy steviol glycoside beverage vs. a sucrose sweetened beverage on gut microflora profile and function over 28 days.
Participants will have a daily exposure to each test product for 28 days. (1) steviol glycosides (flavored water, steviol glycosides) and (2) sucrose (flavored water, sucrose). Individuals will be supplied with fecal collection kits to collect stool samples. The volunteers will be advised to collect a fecal sample before week 0(baseline), week 4(study end) and week 8(follow up period). Fecal microbial alpha diversity, beta diversity, and abundance of microbial taxa between the steviol glycoside and sucrose beverage consuming groups will be evaluated as well as fecal SCFA concentration, fasting serum insulin, glucose and lipids, weight, BMI, pulse and blood pressure at weeks 0(baseline),4(study end) and 8(follow up).
- Conditions
- Healthy, Human Gut Microflora
- Being tested
- Sucrose, Steviol Glycosides
- Keywords
- Steviol glycosides, gut microflora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseOther
Also called Sugar
Sucrose Beverage
Steviol GlycosidesOther
Also called Stevia
Steviol Glycoside Beverage
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Active comparator | sucrose sweetened beverage 16 oz (473 ml) given daily for 28 days Receives: Other: Sucrose |
| Steviol glycosides | Experimental | steviol glycosides sweetened beverage 16 oz (473 ml) given daily for 28 days Receives: Other: Steviol Glycosides |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of daily steviol glycosides consumption compared to the effects of daily sucrose consumption over 28 days on the alpha diversity, beta diversity, and abundance of microbial taxa in the human gut of healthy adults.
shotgun metagenomic sequencing at baseline and after 28 day intervention
Measured: 28 days
Secondary outcomes (17)
The effects of a daily steviol glycoside beverages compared to a sucrose beverage on fecal microflora short chain fatty acid (SCFA) production over 28 days.
ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS)
Measured: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on body weight over 28 days
Weight is measured in kg by a digital weighing scale at baseline and at 28 days
Measured: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on BMI over 28 days
BMI will be measured as kg/m^2 at baseline and at 28 days. Weight (in kg) and height (in meters) will be combined to report BMI
Measured: 28 days
The effects of a daily steviol glycoside compared to a sucrose beverage on blood pressure over 28 days
Blood pressure (systolic and diastolic) will be measured as mmHg at baseline and at 28 days
Measured: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverages on pulse over 28 days
pulse rate (BPM) will be measured over 30 seconds at baseline and at 28 days
Measured: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood insulin over 28 days
Fasting blood insulin mciU/dl at baseline and at 28 days
Measured: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood glucose over 28 days
Fasting blood glucose will be measured in mg/dl at baseline and at 28 days
Measured: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood lipids over 28 days
Fasting blood lipids (total cholesterol, HDL, LDL, triglycerides) in mg/dl at baseline and at 28 days
Measured: 28 days
Measurement and comparison of fecal microflora alpha diversity, beta diversity, and abundance of microbial taxa in the human gut of healthy adults at 28 days post intervention
During a 28 day post intervention period, volunteers will not consume a steviol glycoside or sucrose beverages. Microbial comparisons will be made by shotgun metagenomic sequencing on fecal samples taken at 28 days post intervention
Measured: 28 days post intervention
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fecal short chain fatty acid (SCFA) production at 28 days post intervention
During a 28 day post intervention period, volunteers will not consume a steviol glycoside or sucrose beverage. Fecal SCFA production will be measured by ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) in fecal samples taken at 28 days post intervention
Measured: 28 days post intervention
28 day post intervention changes in body weight
During a 28 day post intervention period, volunteers will not consume a steviol glycoside beverage or sucrose beverage. Body Weight will be measured in kg by a digital weighing scale at 28 days post intervention
Measured: 28 days post intervention
28 day post intervention changes in BMI
During a 28 day post intervention period, volunteers will not consume a steviol glycoside beverage or sucrose beverage. BMI will be measured as kg/m^2 taken at 28 days post intervention. Weight (in kg) and height (in meters) will be combined to report BMI
Measured: 28 days post intervention
28 day post intervention changes in Blood Pressure
During a 28 day post intervention period, volunteers will not consume a steviol glycoside beverage or sucrose beverage. Blood pressure (systolic and diastolic) will be measured as mmHg at 28 days post intervention
Measured: 28 days post intervention
28 day post intervention changes in pulse rate
During a 28 day post intervention period, volunteers will not consume a steviol glycoside beverage or sucrose beverage. Pulse rate (BPM) will be measured over 30 seconds at 28 days post intervention
Measured: 28 days post intervention
28 day post intervention changes in fasting blood insulin
During a 28 day post intervention period, volunteers will not consume a steviol glycoside beverage or sucrose beverage. Fasting blood insulin in mciU/dl taken at 28 days post intervention
Measured: 28 days post intervention
28 day post intervention changes in fasting blood glucose
During a 28 day post intervention period, volunteers will not consume a steviol glycoside beverage or sucrose beverage. Fasting blood glucose will be measured in mg/dl taken at 28 days post intervention
Measured: 28 days post intervention
28 day post intervention changes in fasting blood lipids
During a 28 day post intervention period, volunteers will not consume a steviol glycoside beverage or sucrose beverage. Fasting blood lipids (total cholesterol, HDL, LDL, triglycerides) in mg/dl taken at 28 days post intervention
Measured: 28 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start15 Feb 2022
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cargill
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264636
- Sponsor's protocol ID
- INQ-2125
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwok D, Scott C, Strom N, Au-Yeung F, Lam C, Chakrabarti A, Hutton T, Wolever TM. Comparison of a Daily Steviol Glycoside Beverage compared with a Sucrose Beverage for Four Weeks on Gut Microbiome in Healthy Adults. J Nutr. 2024 Apr;154(4):1298-1308. doi: 10.1016/j.tjnut.2024.01.032. Epub 2024 Feb 24.
PubMed 38408729
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a 28-day Steviol Glycoside Beverage on Human Gut Microflora Profile and Function vs. a Sucrose Beverage in Healthy Adults
- ClinicalTrials.gov ID
- NCT05264636
- Acronym / sponsor ID
- INQ-2125
- Conditions
- Healthy, Human Gut Microflora
- Keywords
- Steviol glycosides, gut microflora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- CargillIndustry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 3 Mar 2022 (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.
Diet and dietary ingredients can have a profound effect on gut microflora, both positive and negative. The reported effects on low and non caloric sweeteners (LNCS) on human gut microflora are contradictory in some of the in vitro and rodent studies. More specifically, the latter studies, using doses above the acceptable daily intake (ADI), suggest that LNCS may have adverse effects on gut microflora whereas recent data from human RCTs, using doses at or below the ADI, show little to no effect. In this study we will compare the effects of a low energy beverage made with steviol glycosides vs. a beverage made with sucrose on human gut microflora profile and function in a double blind, randomized study. A sucrose beverage was chosen as a control as it represents a caloric sugar sweetened beverage which is commonly consumed.
Detailed description
This is a double blind randomized parallel study with 2 treatments to understand the effects of a low energy steviol glycoside beverage vs. a sucrose sweetened beverage on gut microflora profile and function over 28 days.
Participants will have a daily exposure to each test product for 28 days. (1) steviol glycosides (flavored water, steviol glycosides) and (2) sucrose (flavored water, sucrose). Individuals will be supplied with fecal collection kits to collect stool samples. The volunteers will be advised to collect a fecal sample before week 0(baseline), week 4(study end) and week 8(follow up period). Fecal microbial alpha diversity, beta diversity, and abundance of microbial taxa between the steviol glycoside and sucrose beverage consuming groups will be evaluated as well as fecal SCFA concentration, fasting serum insulin, glucose and lipids, weight, BMI, pulse and blood pressure at weeks 0(baseline),4(study end) and 8(follow up).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Active comparator | Other: Sucrosesucrose sweetened beverage 16 oz (473 ml) given daily for 28 days |
| Steviol glycosides | Experimental | Other: Steviol Glycosidessteviol glycosides sweetened beverage 16 oz (473 ml) given daily for 28 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Generally healthy
- Non-pregnant, non-lactating individuals at least 25 of whom are male and 25 female
- Aged 18-50 years, inclusive
- BMI 18.5 to 24.9, inclusive
- Has access to a phone or tablet and wifi (to complete app based 3DDR)
Key exclusion criteria (13 listed)
- Failure to meet any one of the inclusion criteria
- Use of prebiotic or probiotic supplement one month prior to the study and during the entire duration of the study
- Smokers (cigarettes, vape or marijuana)
- Habitual consumption of >1.5L sugar sweetened beverages (eg. juice, soft drinks) per day
- High alcohol consumption (>14 drinks per week and >4 drinks per day for males; and >7 drinks per week and >3 drinks per day for females), or history of alcohol abuse. Alcohol intake during the study must stay below these limits listed above
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 |
|---|---|---|
| SucroseAlso: SugarSucrose Beverage | Other | Sucrose |
| Steviol GlycosidesAlso: SteviaSteviol Glycoside Beverage | Other | Steviol glycosides |
Primary outcome
The effects of daily steviol glycosides consumption compared to the effects of daily sucrose consumption over 28 days on the alpha diversity, beta diversity, and abundance of microbial taxa in the human gut of healthy adults.
Time frame: 28 days
shotgun metagenomic sequencing at baseline and after 28 day intervention
17 secondary outcomes
The effects of a daily steviol glycoside beverages compared to a sucrose beverage on fecal microflora short chain fatty acid (SCFA) production over 28 days.
Time frame: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on body weight over 28 days
Time frame: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on BMI over 28 days
Time frame: 28 days
The effects of a daily steviol glycoside compared to a sucrose beverage on blood pressure over 28 days
Time frame: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverages on pulse over 28 days
Time frame: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood insulin over 28 days
Time frame: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood glucose over 28 days
Time frame: 28 days
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood lipids over 28 days
Time frame: 28 days
Measurement and comparison of fecal microflora alpha diversity, beta diversity, and abundance of microbial taxa in the human gut of healthy adults at 28 days post intervention
Time frame: 28 days post intervention
The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fecal short chain fatty acid (SCFA) production at 28 days post intervention
Time frame: 28 days post intervention
28 day post intervention changes in body weight
Time frame: 28 days post intervention
28 day post intervention changes in BMI
Time frame: 28 days post intervention
28 day post intervention changes in Blood Pressure
Time frame: 28 days post intervention
28 day post intervention changes in pulse rate
Time frame: 28 days post intervention
28 day post intervention changes in fasting blood insulin
Time frame: 28 days post intervention
28 day post intervention changes in fasting blood glucose
Time frame: 28 days post intervention
28 day post intervention changes in fasting blood lipids
Time frame: 28 days post intervention
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 28 Apr 2023.
- Derived from this study: PubMed 38408729Kwok D, Scott C, Strom N, Au-Yeung F, Lam C, Chakrabarti A, Hutton T, Wolever TM. Comparison of a Daily Steviol Glycoside Beverage compared with a Sucrose Beverage for Four Weeks on Gut Microbiome in Healthy Adults. J Nutr. 2024 Apr;154(4):1298-1308. doi: 10.1016/j.tjnut.2024.01.032. Epub 2024 Feb 24.
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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 Sucrose and Steviol Glycosides in people with Healthy and Human Gut Microflora, run by Cargill 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 10 inclusion and 13 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 28 Apr 2023. 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?
The effects of daily steviol glycosides consumption compared to the effects of daily sucrose consumption over 28 days on the alpha diversity, beta diversity, and abundance of microbial taxa in the human gut of healthy adults. (time frame: 28 days). 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 NCT05264636, which also lists 1 linked publication.
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 28 Apr 2023.