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Steviol glycosides for Healthy Subjects

N/A
Waitlist Available
Research Sponsored by Cargill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study 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.

Eligible Conditions
  • Healthy Subjects
  • Gut Microbiome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
28 day post intervention changes in BMI
28 day post intervention changes in Blood Pressure
28 day post intervention changes in body weight
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Steviol glycosidesExperimental Treatment1 Intervention
steviol glycosides sweetened beverage 16 oz (473 ml) given daily for 28 days
Group II: SucroseActive Control1 Intervention
sucrose sweetened beverage 16 oz (473 ml) given daily for 28 days

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Who is running the clinical trial?

INQUIS Clinical Research Ltd.Industry Sponsor
7 Previous Clinical Trials
236 Total Patients Enrolled
INQUIS Clinical ResearchUNKNOWN
9 Previous Clinical Trials
266 Total Patients Enrolled
CargillLead Sponsor
26 Previous Clinical Trials
3,130 Total Patients Enrolled

Frequently Asked Questions

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~19 spots leftby Apr 2025