CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 95 enrolled
Drug / intervention
sucralose 48 mg (splenda)/day for ten weeksdietary
Likely dose
sucralose 48 mg (splenda)/day for ten weeksfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03703141
NCT03703141N/ACompleted

Effect of Acute or Chronic Ingestion of Sucralose on Serum Insulin in Young and Healthy Adults: a Randomized, Double-blind, Placebo-controlled Trial

Hospital General de México Dr. Eduardo Liceaga·interventional·Posted Oct 11, 2018·Updated Oct 11, 2018

In Brief

A clinical study evaluating sucralose 48 mg (splenda)/day for ten weeks for Healthy. Completed, enrolled 95 participants.

Detailed Summary

The consumption of non-caloric sweeteners has increased worldwide; Current publications suggest its consumption associates to insulin resistance. The present study aims to demonstrate whether acute or chronic sucralose exposure affects insulin or carbohydrate metabolism or alters systemic inflammatory markers and microbiota in young, healthy adults. In this prospective, randomized, double-blind, placebo-controlled clinical trial, three groups will be included with 30 healthy volunteers each. Group A will receive sucralose 48 mg/ day, group B 96 mg/day and group C plain water as placebo. Subjects will be exposed to acute (one day) and chronic (seventy days) oral sucralose ingestion. After acute or chronic exposure, volunteers will undergo into an Oral Glucose Tolerance Test (OGTT), taking blood samples at -15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively. Areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes as described; for C peptide, glucagon, GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide) measure points will be at 0, 30 and 60 minutes only. Differences between one and seventy days AUC means will be compared between the three groups, adjusting for BMI. Besides, initial and final systemic inflammatory markers and inflammatory monocytes levels will be quantified and compare between acute and chronic exposure. Also, a comparison between the percentage of acute and chronic microbiome bacterial population in feces will be made.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 11, 2018
Enrollment StartSep 27, 2016
Primary CompletionJun 4, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.7 years ago

Interventions

sucralose 48 mg (splenda)/day for ten weeksdietary

volunteers will take sucralose or placebo daily for 70 days