Low-calorie Sweeteners and Adipose Signaling
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMay 18, 2022
May 1, 2022
2 years
April 19, 2017
May 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transcriptomics
Within-subjects changes in adipose gene expression will be evaluated using RNAseq
Pre/post 8 weeks of diet soda
Study Arms (1)
Diet Soda
EXPERIMENTALSubjects will be asked to consume a diet soda three times daily for eight weeks.
Interventions
Subjects will be asked to consume diet soda three times daily for eight weeks.
Eligibility Criteria
You may qualify if:
- Female
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Milken Institute School of Public Health and GW Medical Faculty Associates
Washington D.C., District of Columbia, 20052, United States
Related Publications (1)
Sylvetsky AC, Clement RA, Stearrett N, Issa NT, Dore FJ, Mazumder R, King CH, Hubal MJ, Walter PJ, Cai H, Sen S, Rother KI, Crandall KA. Consumption of sucralose- and acesulfame-potassium-containing diet soda alters the relative abundance of microbial taxa at the species level: findings of two pilot studies. Appl Physiol Nutr Metab. 2024 Jan 1;49(1):125-134. doi: 10.1139/apnm-2022-0471. Epub 2023 Oct 30.
PMID: 37902107DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 24, 2017
Study Start
January 1, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
May 18, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share