Back to resultsSucralose, Stevia, Gut Microbiome and Glucose Metabolism
Primary Purpose
Impaired Glucose Tolerance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sucralose
Stevia
Sponsored by
About this trial
This is an interventional basic science trial for Impaired Glucose Tolerance
Eligibility 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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Sites / Locations
- ECRC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sucralose
Stevia
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
2-hour glucose
An oral glucose tolerance test will be administered before and after consuming assigned sweetener to determine change in 2-hour glucose
Secondary Outcome Measures
Gut microbiome
Gut microbiota will be measured before and after consuming assigned sweetener to determine change in gut microbiota.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02800707
Brief Title
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
Official Title
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sucralose
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Stevia
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Sucralose
Intervention Description
Sweetner
Intervention Type
Other
Intervention Name(s)
Stevia
Intervention Description
Sweetner
Primary Outcome Measure Information:
Title
2-hour glucose
Description
An oral glucose tolerance test will be administered before and after consuming assigned sweetener to determine change in 2-hour glucose
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Gut microbiome
Description
Gut microbiota will be measured before and after consuming assigned sweetener to determine change in gut microbiota.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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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Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyn M Steffen, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
ECRC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will not be made available.
Learn more about this trial
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
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