Sucralose Question

Question:
I have a question regarding Sucralose in the Pro argi 9 plus. How much of this substance is present in this product because it seems that some have contradictions regarding sucralose. I would just like to get somewhat of an idea so that we can clear up any questions when recommending your product.

Answer from Synergy Worldwide:
ProArgi-9 Plus contains a very small amount of sucralose, approximately 35 mg per scoop.

Sucralose is a sugar substitute produced from sucrose or table sugar. Sucralose underwent 20 years of safety and toxicity research before it was approved by the United States FDA in 1998. Since then it has been approved by 60 countries including the Joint FAO/WHO Expert Committee on Food Additives, The European Union, and Canada’s Health Protection Branch. Sucralose has been shown to be safe even in high doses in animal and human studies.

Below are some study abstracts regarding the safety of sucralose in human subjects:

Abstract 1:
Baird IM, Shephard NW, Merritt RJ, Hildick-Smith G. Repeated dose study of sucralose tolerance in human subjects. Food Chem Toxicol. 2000;38 Suppl 2:S123-9.

Two tolerance studies were conducted in healthy human adult volunteers. The first study was an ascending dose study conducted in eight subjects, in which sucralose was administered at doses of 1, 2. 5, 5 and 10mg/kg at 48-hour intervals and followed by daily dosing at 2mg/kg for 3 days and 5mg/kg for 4 days. In the second study, subjects consumed either sucralose (n=77) or fructose (50g/day) (n=31) twice daily in single blind fashion. Sucralose dosage levels were 125mg/day for weeks 1-3, 250mg/day during weeks 4-7, and 500mg/day during weeks 8-12. No adverse experiences or clinically detectable effects were attributable to sucralose in either study. Similarly, haematology, serum biochemistry, urinalysis and EKG tracings were unaffected by sucralose administration. In the 13-week study, serial slit lamp ophthalmologic examination performed in a random subset of the study groups revealed no changes. Fasting and 2-hour post-dosing blood sucralose concentrations obtained daily during week 12 of the study revealed no rising trend for blood sucralose. Sucralose was well tolerated by human volunteers in single doses up to 10mg/kg/day and repeated doses increasing to 5mg/kg/day for 13 weeks. Based on these studies and the extensive animal safety database, there is no indication that adverse effects on human health would occur from frequent or long-term exposure to sucralose at the maximum anticipated levels of intake.

Abstract 2:
Grotz VL, Henry RR, McGill JB, Prince MJ, Shamoon H, Trout JR, Pi-Sunyer FX. Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes. J Am Diet Assoc. 2003 Dec;103(12):1607-12.

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. DESIGN: 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. SUBJECTS/SETTING: 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. INTERVENTION: 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. MAIN OUTCOME MEASURES: 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.

PMID: 14647086 [PubMed - indexed for MEDLINE]

Abstract 3:
Knight I. The development and applications of sucralose, a new high-intensity sweetener. Can J Physiol Pharmacol. 1994 Apr;72(4):435-9.

Sucralose is a new sweetener discovered during a collaborative research program between Tate & Lyle and Queen Elizabeth College of the University of London. It is made by selective substitution of sucrose hydroxyl groups by chlorine, resulting in a highly intense (600x) sugar-like sweetness and exceptional stability at both high temperature and low pH. The research leading to the discovery of sweetness in differently halogenated sucrose is described, as well as the development of sucralose and the process of safety testing and government approval. Finally, sucralose properties and applications in Canada's food and beverage industries are discussed.

PMID: 7922876 [PubMed - indexed for MEDLINE]

According to the International Food Information Counsil:

“Sucralose has an excellent safety profile. More than 100 scientific studies conducted over a 20-year period demonstrate that sucralose is safe for use as a sweetening ingredient. The data from the studies were independently evaluated by international experts in a variety of scientific disciplines, including toxicology, oncology, teratology, neurology, hematology, pediatrics and nutrition. Importantly, comprehensive toxicology studies, designed to meet the highest scientific standards, have clearly demonstrated that sucralose is not carcinogenic.”

And:

“Among the regulatory bodies that have evaluated the safety of sucralose are the U.S. FDA, the Joint FAO/WHO Expert Committee on Food Additives (JECFA); the Health Protection Branch of Health and Welfare Canada; Food Standards Australia/New Zealand, the European Union’s Scientific Committee on Food, and a host of others in South America and Asia. Sucralose is now permitted for use in over 60 countries.”

And:

“Sucralose is an essentially inert molecule. It passes through the body unchanged, is not metabolized, and is eliminated after consumption.”

Reference: IFIC Foundation. Sucralose. 2007. Available at: http://www.ific.org/publications/brochures/sucralosebroch.cfm

Also see: Daniel JW, Renwick AG, Roberts A, Sims J. The metabolic fate of sucralose in rats. Food Chem Tox. 2000;38(S2): S115-S121.

The FDA reviewed data from more than 110 studies in humans and animals to determine the safety of sucralose. Sucralose was not found to have reproductive or neurological effects or to be carcinogenic and FDA's approval is based on the finding that sucralose is safe for human consumption.

Reference: FDA Talk Paper: FDA Approves New High-Intensity Sweetener Sucralose. 1998. Available at: http://vm.cfsan.fda.gov/~lrd/tpsucral.html

According to the Canadian Diabetes Association, one can consume 15 mg/kg/day of Sucralose "on a daily basis over a ... lifetime without any adverse effects" For an average size person, this is equal to about 1000 mg of sucralose per day every day over a lifetime.

Reference: 2003 Clinical Practice Guidelines. Acceptable Daily Intake of Sweeteners. 2003. Available at: http://www.diabetes.ca/cpg2003/chapters.aspx?table1acceptabledailyintakeofsweeteners.htm

I hope this information is helpful