Clinical trial NCT05264636: The Impact of Steviol Glycosides on Human Gut Microflora Profile and Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Human Gut Microflora
Keywords: Steviol glycosides
gut microflora
Lead sponsor: Cargill
Sponsor class: INDUSTRY
Collaborators: name: INQUIS Clinical Research
First posted: 2022-03-03
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
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.
timeFrame: 28 days
Secondary outcomes:
measure: 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.
timeFrame: 28 days
measure: The effects of a daily steviol glycoside beverage compared to a sucrose beverage on body weight over 28 days
timeFrame: 28 days
measure: The effects of a daily steviol glycoside beverage compared to a sucrose beverage on BMI over 28 days
timeFrame: 28 days
measure: The effects of a daily steviol glycoside compared to a sucrose beverage on blood pressure over 28 days
timeFrame: 28 days
measure: The effects of a daily steviol glycoside beverage compared to a sucrose beverages on pulse over 28 days
timeFrame: 28 days
measure: The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood insulin over 28 days
timeFrame: 28 days
measure: The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood glucose over 28 days
timeFrame: 28 days
measure: The effects of a daily steviol glycoside beverage compared to a sucrose beverage on fasting blood lipids over 28 days
timeFrame: 28 days
measure: 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
timeFrame: 28 days post intervention
measure: 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
timeFrame: 28 days post intervention
measure: 28 day post intervention changes in body weight
timeFrame: 28 days post intervention
measure: 28 day post intervention changes in BMI
timeFrame: 28 days post intervention
measure: 28 day post intervention changes in Blood Pressure
timeFrame: 28 days post intervention
measure: 28 day post intervention changes in pulse rate
timeFrame: 28 days post intervention
measure: 28 day post intervention changes in fasting blood insulin
timeFrame: 28 days post intervention
measure: 28 day post intervention changes in fasting blood glucose
timeFrame: 28 days post intervention
measure: 28 day post intervention changes in fasting blood lipids
timeFrame: 28 days post intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Inquis
state: Ontario
Study officials:
References: