Sucralose, Stevia, Gut Microbiome and Glucose Metabolism

NCT ID: NCT02800707

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2018-01-31

Brief Summary

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

Detailed Description

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This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women aged 35-55 years.

Conditions

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Impaired Glucose Tolerance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Sucralose

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).

Group Type ACTIVE_COMPARATOR

Sucralose

Intervention Type OTHER

Sweetner

Stevia

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).

Group Type ACTIVE_COMPARATOR

Stevia

Intervention Type OTHER

Sweetner

Interventions

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Sucralose

Sweetner

Intervention Type OTHER

Stevia

Sweetner

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyn M Steffen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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ECRC

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1605M88288

Identifier Type: -

Identifier Source: org_study_id

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