Sucralose Effects on Glucose Metabolism and Gut Microbiota

NCT02650947 | Completed DMC

• 1 other identifier: 09-58-16
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis:

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

Conditions

Healthy

Keywords

Sucralose; Insulin Secretion; Insulin Sensitivity; Incretin; Gut Microbiota; Food and Eating Behaviour; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The effect of sucralose on insulin secretion

  We will measure plasma insulin concentrations before and at 0, 2, 3, 4, 5, 6, 8, 10 minutes after administered intravenously 50%glucose 0.3 g/kg within 1 minute. All these data collected were used to calculate acute insulin response to glucose.

  2 hours

Secondary Outcomes (4)

• Glucagon-like peptide-1 secretion

  2 hours

• Gut microbiota

  4 weeks

• Food record

  4 weeks

• The effect of sucralose on insulin sensitivity

  2 hours

Study Arms (2)

Sucralose

EXPERIMENTAL

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.

Dietary Supplement: Sucralose

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Sucralose DIETARY_SUPPLEMENT

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

Also known as: Trichlorosucrose

Sucralose

Placebo DIETARY_SUPPLEMENT

Consumption of empty capsule everyday for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead
• The Endocrine Society of Thailand: collaborator

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Insulin Resistance; Feeding Behavior

Interventions

trichlorosucrose

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Study Officials

• Chutintorn Sriphrapradang, M.D.

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 2, 2016
• First Posted: January 8, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

TH (1)