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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

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date March 22, 2018
Actual Study Start Date  ICMJE January 3, 2017
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
Gut microbiome [ Time Frame: 14 days ]
Gut microbiota will be measured before and after consuming assigned sweetener to determine change in gut microbiota.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
Official Title  ICMJE Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Impaired Glucose Tolerance
Intervention  ICMJE
  • Other: Sucralose
    Sweetner
  • Other: Stevia
    Sweetner
Study Arms  ICMJE
  • 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).
    Intervention: Other: Sucralose
  • 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).
    Intervention: Other: Stevia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 10, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800707
Other Study ID Numbers  ICMJE 1605M88288
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual data will not be made available.
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lyn M Steffen, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP