Sucralose, Stevia, Gut Microbiome and Glucose Metabolism

Not Applicable

Completed

• Conditions: Impaired Glucose Tolerance
• Interventions: Other: Sucralose; Other: Stevia

• Registration Number: NCT02800707
• Lead Sponsor: University of Minnesota

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Study Start: 2017-01-03
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Generally health adult men and women aged 35-55 years old -

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Exclusion Criteria

Adults will not be eligible who have chronic disease (cancer, CHD, diabetes, chronic kidney disease); pregnant or breast feeding; menopausal; has a history of bariatric surgery; taking prednisone/steroids, taking medication for PCOS, or take medications that influence blood glucose.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sucralose	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).
Stevia	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).

Primary Outcome Measures

Name	Time	Method
2-hour glucose	14 days	An oral glucose tolerance test will be administered before and after consuming assigned sweetener to determine change in 2-hour glucose

Secondary Outcome Measures

Name	Time	Method
Gut microbiome	14 days	Gut microbiota will be measured before and after consuming assigned sweetener to determine change in gut microbiota.

Trial Locations

Locations (1)

ECRC; 🇺🇸 Minneapolis, Minnesota, United States