Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes.
OBJECTIVE
To investigate the effect of 3-months' daily administration of high doses of sucralose, a non-nutritive sweetener, on glycemic control in subjects with type 2 diabetes.


METHODS
A multicenter, double-blind, placebo-controlled, randomized study, consisting of a 6-week screening phase, a 13-week test phase, and a 4-week follow-up phase.


METHODS
Subjects with type 2 diabetes (age range 31 to 70 years) entered the test phase of this study; 128 subjects completed the study. The subjects were recruited from 5 medical centers across the United States and were, on average, obese.


METHODS
Subjects were randomly assigned to receive either placebo (cellulose) capsules (n=69) or 667 mg encapsulated sucralose (n=67) daily for the 13-week test phase. All subjects blindly received placebo capsules during the last 4 weeks of the screening phase and for the entire 4-week follow-up phase.


METHODS
Glycated hemoglobin (HbA1c), fasting plasma glucose, and fasting serum C-peptide were measured approximately every 2 weeks to evaluate blood glucose homeostasis. Data were analyzed by analysis of variance using repeated measures.


RESULTS
There were no significant differences between the sucralose and placebo groups in HbA1c, fasting plasma glucose, or fasting serum C-peptide changes from baseline. There were no clinically meaningful differences between the groups in any safety measure.


CONCLUSIONS
This study demonstrated that, similar to cellulose, sucralose consumption for 3 months at doses of 7.5 mg/kg/day, which is approximately three times the estimated maximum intake, had no effect on glucose homeostasis in individuals with type 2 diabetes. Additionally, this study showed that sucralose was as well-tolerated by the study subjects as was the placebo.
Grotz
V Lee
VL
Medical and Nutritional Affairs, McNeil Nutritionals, New Bruswick, NJ 08903-2400, USA. lgrotz@mspus.jnj.com
Henry
Robert R
RR
McGill
Janet B
JB
Prince
Melvin J
MJ
Shamoon
Harry
H
Trout
J Richard
JR
Pi-Sunyer
F Xavier
FX
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D002096:C-Peptide / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000378:metabolism*; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006706:Homeostasis / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D013395:Sucrose / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology*; D013549:Sweetening Agents / Q000008:administration & dosage / Q000494:pharmacology*
D001786:Blood Glucose; D002096:C-Peptide; D006442:Glycated Hemoglobin; D013395:Sucrose; D013549:Sweetening Agents; C026285:trichlorosucrose