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OpenTrials
Completed

NCT Number: NCT03125356

Low-calorie Sweeteners and Adipose Signaling

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.

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Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Milken Institute School of Public Health and GW Medical Faculty Associates

Washington D.C., District of Columbia, 20052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet Soda

Other

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

Primary outcomes

  1. Transcriptomics

    Time frame: Pre/post 8 weeks of diet soda

    Within-subjects changes in adipose gene expression will be evaluated using RNAseq

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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