NCT02800707

Brief Summary

This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

January 3, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

June 10, 2016

Last Update Submit

March 21, 2018

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • 2-hour glucose

    An oral glucose tolerance test will be administered before and after consuming assigned sweetener to determine change in 2-hour glucose

    14 days

Secondary Outcomes (1)

  • Gut microbiome

    14 days

Study Arms (2)

Sucralose

ACTIVE COMPARATOR

Participants will be asked to consume 180 mg/day of sucralose (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 340 mg/day of sucralose (or 5.5 12-oz cans of sucralose-sweetened diet soda).

Other: Sucralose

Stevia

ACTIVE COMPARATOR

Participants will be asked to consume 180 mg/day of stevia (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 800 mg/day of stevia (or about 12 cans of stevia-sweetened diet soda).

Other: Stevia

Interventions

SucraloseOTHER

Sweetner

Sucralose
SteviaOTHER

Sweetner

Stevia

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ECRC

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

trichlorosucrosestevioside

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lyn M Steffen, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 15, 2016

Study Start

January 3, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Individual data will not be made available.

Locations

US(1)