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Sucralose, Stevia, Gut Microbiome and Glucose Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800707
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Other: Sucralose Other: Stevia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Stevia

Arm Intervention/treatment
Active Comparator: 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).
Other: Sucralose
Sweetner

Active Comparator: 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).
Other: Stevia
Sweetner




Primary Outcome Measures :
  1. 2-hour glucose [ Time Frame: 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 :
  1. Gut microbiome [ Time Frame: 14 days ]
    Gut microbiota will be measured before and after consuming assigned sweetener to determine change in gut microbiota.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800707


Locations
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United States, Minnesota
ECRC
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Lyn M Steffen, PhD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02800707    
Other Study ID Numbers: 1605M88288
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be made available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases