Skip to content

Low-calorie Sweeteners and Adipose Signaling

Low-calorie Sweeteners and Adipose Signaling

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03125356
Enrollment
10
Registered
2017-04-24
Start date
2017-01-01
Completion date
2018-12-31
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional and Metabolic Diseases

Keywords

diet soda, low-calorie sweeteners, obesity

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.

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.

Interventions

Subjects will be asked to consume diet soda three times daily for eight weeks.

Sponsors

George Washington University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

1. Female 2. 18-25 years of age 3. Overweight and mild to moderate obesity (25 ≤ body mass index (BMI) \<35 kg/m2) 4. Consumption of \<1 food/beverage with sucralose and/or acesulfame-potassium per month 5. Able and willing to comply with all study procedures for the duration of the study

Exclusion criteria

1. Overt diabetes 2. Renal/gastrointestinal conditions 3. Pregnant/lactating 4. Recent significant weight change 5. Acute illness (w/fever) 6. Antibiotics in past 3 months 7. Use of illegal drugs/condition limiting ability to give consent.

Design outcomes

Primary

MeasureTime frameDescription
TranscriptomicsPre/post 8 weeks of diet sodaWithin-subjects changes in adipose gene expression will be evaluated using RNAseq

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026