The Impact of Steviol Glycosides on Human Gut Microflora Profile and Function

NCT05264636 | Completed

• 1 other identifier: INQ-2125
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Human Gut Microflora

Keywords

Steviol glycosides; gut microflora

Outcome Measures

Primary Outcomes (1)

• 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

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.

  28 days

• The effects of a daily steviol glycoside beverage compared to a sucrose beverage on body weight over 28 days

  28 days

• The effects of a daily steviol glycoside beverage compared to a sucrose beverage on BMI over 28 days

  28 days

• The effects of a daily steviol glycoside compared to a sucrose beverage on blood pressure over 28 days

  28 days

• The effects of a daily steviol glycoside beverage compared to a sucrose beverages on pulse over 28 days

  28 days

Study Arms (2)

Sucrose

ACTIVE COMPARATOR

sucrose sweetened beverage 16 oz (473 ml) given daily for 28 days

Other: Sucrose

Steviol glycosides

EXPERIMENTAL

steviol glycosides sweetened beverage 16 oz (473 ml) given daily for 28 days

Other: Steviol Glycosides

Interventions

Sucrose OTHER

Sucrose Beverage

Also known as: Sugar

Sucrose

Steviol Glycosides OTHER

Steviol Glycoside Beverage

Also known as: Stevia

Steviol glycosides

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cargill: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

Inquis

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

• 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.

  PMID: 38408729 DERIVED

MeSH Terms

Interventions

Sucrose; Sugars; stevioside

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: intervention products are coded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 3, 2022
• Study Start: February 15, 2022
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

CA (1)