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| Name | Class |
|---|---|
| INQUIS Clinical Research | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sucrose | Active Comparator | sucrose sweetened beverage 16 oz (473 ml) given daily for 28 days |
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| Steviol glycosides | Experimental | steviol glycosides sweetened beverage 16 oz (473 ml) given daily for 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrose | Other | Sucrose Beverage |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 28 days |
| The effects of a daily steviol glycoside beverage compared to a sucrose beverage on body weight over 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inquis | Toronto | Ontario | M5C 2N8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38408729 | Derived | 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. |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| D000073893 | Sugars |
| C012043 | stevioside |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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intervention products are coded
| Steviol Glycosides |
| Other |
Steviol Glycoside Beverage |
|
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Weight is measured in kg by a digital weighing scale at baseline and at 28 days |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 28 days post intervention |