The rebiana safety evaluation program included metabolism and pharmacokinetic studies, general and multi-generational safety studies, intake studies and human studies. Cargill sponsored the studies to affirm earlier safety findings for purified steviol glycosides, and to confirm that rebiana is broken down by the body in the same way as stevioside, which has been studied extensively. Rebaudioside A - the main component of rebiana - is nearly identical in chemical structure to stevioside.
Study
|
Top-line Findings
|
Implications
|
| Metabolism and pharmacokinetic studies |
- Metabolism of rebaudioside A is similar to that of stevioside
|
- Safety data from stevioside studies can be applied to rebiana
- The safety of rebiana is supported by a large database of scientific research
|
| General safety |
- No negative effects on general health associated with doses equivalent to a 150-lb person drinking more than 2,000 8-ounce servings of a rebiana-sweetened beverage
- No treatment-related effects on any organ, including kidneys and male reproductive organs
|
- Supports safety of high-purity steviol glycoside ingredients, including rebiana
- Refutes outdated studies suggesting adverse effects of stevia or stevioside on male reproductive organs (1985, 1999) or on kidney function (1988, 1994, 1997)
- Rebiana does not affect general health or organ function
|
| Multi-generational/ reproductive toxicology |
- Daily consumption equivalent to a 150-lb person drinking nearly 1,000 8-oz servings of a rebiana-sweetened beverage had no negative effects on general health, reproduction, growth or development of adults or their offspring
|
- Refutes studies (1968, 1985, 1998, 1999) suggesting potential adverse effects on male or female fertility, or health of offspring
- Rebiana does not affect reproductive health or health of offspring
|
| Chronic blood pressure study |
- Daily consumption of 1,000 mg rebiana - equivalent to drinking more than eight 8-oz servings of a rebiana-sweetened beverage every day - for 4 weeks had no significant blood pressure effects in healthy subjects with normal or low-normal blood pressure
|
- Addresses questions raised by two Taiwanese studies (2000 and 2003) suggesting that stevioside (purity unknown) lowered blood pressure in people with essential hypertension
- Rebiana does not affect blood pressure
|
| Chronic blood sugar study |
- Daily consumption of 1,000 mg of rebiana - equivalent to drinking more than eight 8-ounce servings of a rebiana-sweetened beverage every day - for 16 weeks did not affect blood sugar control and was well-tolerated in people with type 2 diabetes
|
- Addresses questions raised by a single-dose study (2004) suggesting that stevioside reduced levels of blood sugar after meals in people with type 2 diabetes
- Rebiana does not affect blood sugar control in people with type 2 diabetes
|