- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125356
Low-calorie Sweeteners and Adipose Signaling
May 11, 2022 updated by: George Washington University
The purpose of this study is to determine whether eight weeks of low-calorie sweetener (LCS) exposure exerts cardiovascular and/or metabolic effects among LCS-naïve overweight and obese adolescents and young adults.
We will examine changes in gene expression in subcutaneous fat and will correlate these molecular changes with plasma biochemistry.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The proposed study will investigate LCS-induced changes in metabolically "at-risk" young adults, under conditions that reflect typical beverage consumption.
We will first identify molecular pathways potentially affected by LCS (adipose transcriptomics via global RNAseq) and then identify links between LCS-induced gene expression changes and circulating levels of key metabolic biomarkers and clinical outcomes.
We will perform subcutaneous adipose biopsies before and after consumption of 12 ounces of diet soda three times daily for eight weeks.
Within-subjects changes in adipose gene expression will be evaluated using RNAseq.
We will then correlate transcriptomic changes with circulating levels of key inflammatory and metabolic biomarkers, to provide mechanistic insight into which pathways drive clinically-relevant LCS-induced metabolic impairments.
We will measure glucose, insulin, inflammatory markers and adipose-derived hormones before and after eight weeks of LCS exposure.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20052
- Milken Institute School of Public Health and GW Medical Faculty Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- 18-25 years of age
- Overweight and mild to moderate obesity (25 ≤ body mass index (BMI) <35 kg/m2)
- Consumption of <1 food/beverage with sucralose and/or acesulfame-potassium per month
- Able and willing to comply with all study procedures for the duration of the study
Exclusion Criteria:
- Overt diabetes
- Renal/gastrointestinal conditions
- Pregnant/lactating
- Recent significant weight change
- Acute illness (w/fever)
- Antibiotics in past 3 months
- Use of illegal drugs/condition limiting ability to give consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diet Soda
Subjects will be asked to consume a diet soda three times daily for eight weeks.
|
Subjects will be asked to consume diet soda three times daily for eight weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transcriptomics
Time Frame: Pre/post 8 weeks of diet soda
|
Within-subjects changes in adipose gene expression will be evaluated using RNAseq
|
Pre/post 8 weeks of diet soda
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
April 19, 2017
First Submitted That Met QC Criteria
April 19, 2017
First Posted (Actual)
April 24, 2017
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 11, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111635
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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