Low-calorie Sweeteners and Adipose Signaling

Nutritional and Metabolic Diseases Clinical Trial

Official title:

Low-calorie Sweeteners and Adipose Signaling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125356
• Other study ID #: 111635
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2022
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

Other:
• Diet Soda
Subjects will be asked to consume diet soda three times daily for eight weeks.

Locations

Country	Name	City	State
United States	Milken Institute School of Public Health and GW Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptomics	Within-subjects changes in adipose gene expression will be evaluated using RNAseq	Pre/post 8 weeks of diet soda