Low-calorie Sweeteners and Adipose Signaling

Sponsor

George Washington University (Other)

Overall Status

Completed

CT.gov ID

NCT03125356

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional and Metabolic Diseases	Other: Diet Soda	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Low-calorie Sweeteners and Adipose Signaling

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diet Soda Subjects will be asked to consume a diet soda three times daily for eight weeks.	Other: Diet Soda Subjects will be asked to consume diet soda three times daily for eight weeks.

Arm

Intervention/Treatment

Experimental: Diet Soda

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

Other: Diet Soda

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

Outcome Measures

Primary Outcome Measures

Transcriptomics [Pre/post 8 weeks of diet soda]
Within-subjects changes in adipose gene expression will be evaluated using RNAseq

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milken Institute School of Public Health and GW Medical Faculty Associates	Washington	District of Columbia	United States	20052

Sponsors and Collaborators

George Washington University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

George Washington University

ClinicalTrials.gov Identifier:

NCT03125356

Other Study ID Numbers:

111635

First Posted:

Apr 24, 2017

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by George Washington University

diet soda

low-calorie sweeteners

obesity

Additional relevant MeSH terms:

Metabolic Diseases

Study Results

No Results Posted as of May 18, 2022