Sucralose Effects on Glucose Metabolism and Gut Microbiota

NCT ID: NCT02650947

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-04-30

Brief Summary

Hypothesis:

1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults.

2. Long-term consumption of sucralose may alter food behaviour in healthy adults.

Detailed Description

Artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. Artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. However, many emerging evidences showed artificial sweeteners may induce glucose intolerance. The objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Sucralose

Subjects in this group ate capsule filled with sucralose 200 mg for 4 weeks (week 1-4) and measured oral glucose tolerance test (OGTT), acute insulin response (AIR), and gut microbe examination at week 4.

Group Type: EXPERIMENTAL

Sucralose

Intervention Type: DIETARY_SUPPLEMENT

Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks

Placebo

Subjects ate empty capsule (placebo) for 4 weeks (week 1-4) and measured OGTT, AIR, and gut microbe examination at week 4.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Consumption of empty capsule everyday for 4 weeks

Interventions

Sucralose

Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Consumption of empty capsule everyday for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Trichlorosucrose

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers without underlying disease
• Normal oral glucose tolerance test
• Agree to participate by written informed consent

Exclusion Criteria

• Shift workers
• History of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test)
• Malabsorption problem
• Regular consumption of nonnutritive sweeteners
• Liver impairment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3-folds upper normal limit)
• Renal impairment (serum creatinine >1.5 mg/dL)
• Use of medications affecting glucose level such as glucocorticoid, estrogen, androgen
• Pregnant and lactating woman
• Smoking within 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Endocrine Society of Thailand

OTHER

Sponsor Role: collaborator

Ramathibodi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chutintorn Sriphrapradang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chutintorn Sriphrapradang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

Locations

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

09-58-16

Identifier Type: -

Identifier Source: org_study_id