| Study ID | |
| RefID (DistillerSR) | 3808 |
| Reference (authors, year, title, other info) | Noda, K., Nakayama, K., & Oku, T. (1994). Serum glucose and insulin levels and erythritol balance after oral administration of erythritol in healthy subjects. European Journal of Clinical Nutrition, 48(4), 286–292. |
| Source (published/unpublished) | Published |
| Study design | |
| Study type | HCT – Cross‐over trial – Not randomised |
| Type of blinding | Not reported |
| Duration of the study and length of follow‐up | 1 day per test material |
| Subjects | |
| Number of participants in the study | Five participants |
| Number of exposed/non‐exposed subjects or number of cases/controls (if applicable) | Five exposed |
| Sex (male/female) | Males |
| Age (mean or range as reported) | 45–58 |
| Geography (country) | Japan |
| Ethnicity | Not reported |
| Confounders and other variables as reported | Not reported |
| Special health condition of participants | Healthy |
| Inclusion and exclusion criteria in the study | Not reported |
| Other information | |
| Intervention/exposure | |
| Test material | Erythritol |
| Description of the intervention and estimated dietary exposure | Five healthy male subjects received 20% aqueous solution of erythritol in oral dosages of 0.3 g/kg body weight (the average dosage was about 17.3 g/person). One week after the administration of erythritol, they received 20% solution of glucose of the same dosage. Following 12 h fasting, all subjects received each saccharide at 9.30 AM and took lunch at 12.30 PM. They were permitted to take any foods after then except for wine and other fermented foods containing erythritol |
| Co‐exposure description (if applicable) | Not applicable |
| Endpoint measured, measurement time points and methods | Urine samples were collected for 48 h after each administration for determination of erythritol, osmotic pressure, sodium, potassium and chloride. Blood was collected at 0.5, 1, 2, 3, 8 and 24 h for determination of serum insulin, glucose, erythritol, total cholesterol (TC), triacylglycerol (TG), free fatty acids (FFA), sodium, potassium and chloride |
| Were sub‐groups analyses predefined? (yes/no, including justification) | Not applicable |
| Results | |
| Findings reported by the study author/s |
In glucose administration both serum glucose and insulin levels increased rapidly within 30 min and returned to basal values 3 h after dosage. Serum levels of glucose and insulin were not affected for 3 h after erythritol administration. Peak glucose levels were significantly lower after erythritol administration (104 ± 5 mg/dL) than after glucose (142 ± 10 mg/dL). Similarly, insulin release was significantly lower after erythritol administration (7.6 ± 0.9 μU/mL) than after glucose (25.0 ± 3.6 μU/mL). Serum levels of TC and TG were also determined, and no significant difference was found between erythritol and glucose group for 24 h after administration. FFA levels were different between the two groups but they were kept at normal levels. Serum levels of Na, K and Cl were not significantly different between both groups The urine volume for 3 h after erythritol administration at a dose of 0.3 g/kg was not significantly higher than that after glucose administration at the same dosage in humans Osmotic pressure of the urine for 3 h after erythritol administration was slightly higher than that after glucose administration but not significantly so. The urinary excretion of sodium, potassium and chloride for 48 h after the administration showed no significant difference between erythritol and glucose. The plasma concentration of erythritol reached the maximum concentration (426.5 ± 113.4 μg/mL) at 30 min after oral administration and declined to 13.5 ± 3.2 μg/mL at 24 h with a half‐life of 3.4 h, indicating that erythritol was absorbed quickly and excreted readily in humans The cumulative urinary excretion as the intact form of erythritol within 48 h after oral administration (0.3 g/kg) was 90.3 ± 4.5%. The urinary excretion rate of erythritol was 11.6%/h for the period of 0–3 h and decreased to 0.2%/h for the period of 24–48 h |
| Statistical analysis | |
| Statistical methods (including power analyses, multiple comparison, potential sources of bias, adjustment for confounders, test for interactions) | Data were expressed as the mean value and the standard error and were statistically evaluated by Student's t‐test or Duncan's multiple range test using a significance level of p < 0.05. The peak serum concentration of erythritol and the corresponding sampling time were obtained from the observed data. Other pharmacokinetic parameters were calculated by the non‐linear least squares programme Automated Pharmacokinetic Analysis System (Yamaoka & Tanigawara, 1983) with one compartment model on averaged serum levels of erythritol |
| Further information | |
| Study ID | |
| RefID (DistillerSR) | 4297 |
| Reference (authors, year, title, other info) | Yokohama‐shi Seibu Hospital, St. Marianna University School of Medicine, Department of Metabolic Endocrinology and Department of Nutrition. (1992). The effect of erythritol on glucose tolerance in diabetes patients. |
| Source (published/unpublished) | Unpublished |
| Study design | |
| Study type | HCT – Not randomised |
| Type of blinding | Not reported |
| Duration of the study and length of follow‐up | 1 day per test material |
| Subjects | |
| Number of participants in the study | Five participants |
| Number of exposed/non‐exposed subjects or number of cases/controls (if applicable) | Five exposed |
| Sex (male/female) | Gender unspecified |
| Age (mean or range as reported) | Range: 52.4 ± 19.2 |
| Geography (country) | Japan |
| Ethnicity | Not reported |
| Confounders and other variables as reported | Not reported |
| Special health condition of participants | All patients had non‐insulin‐dependent type 2 diabetes mellitus and were hospitalised |
| Inclusion and exclusion criteria in the study | Not reported |
| Other information | All subjects relied only on dietary therapy as treatment and none showed clear hepatic dysfunctions |
| Intervention/exposure | |
| Test material | Erythritol |
| Description of the intervention and estimated dietary exposure |
20 g of erythritol powder was dissolved in 100 mL of water and used as test solution The oral load test was conducted during stable diabetes control of the diabetes patients. The erythritol solution was taken orally at 9 AM, and 10 mL blood samples were taken before and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 h after load. The measuring items included blood glucose, immunoreactive insulin (IRI), non‐esterified fatty acids (NEFA), 3‐hydroxybutyric acid (3‐OHBA) and erythritol. Urine was collected 24 h before and 0–24, 24–48 and 48–72 h after load, and erythritol concentration in urine was measured. The subjects were allowed to eat food 3 h after load Erythritol concentration (in blood and urine) was measured by gas chromatography |
| Co‐exposure description (if applicable) | Not applicable |
| Endpoint measured, measurement time points and methods | The effect on glucose tolerance, the changes in erythritol blood level and the urinary recovery rate |
| Were sub‐groups analyses predefined? (yes/no, including justification) | Not applicable |
| Results | |
| Findings reported by the study author/s |
No significant changes in blood glucose and IRI were noted till 3 h after load NEFA was significantly increased to 0.7 ± 0.3 mEq/L 2 h after load, compared to 0.6 ± 0.2 mEq/L before load, but dropped significantly to 0.2 ± 0.1 mEq/L after ingestion of food (6 h after load). 3‐OHBA also tended to increase till 3 h after load, but dropped after ingestion of food (6 h after load) to 10.4 ± 9.0 μ M/L, showing a significant decrease from the pre‐load level of 79.0 ± 52.3 μ M/L Blood erythritol level reached a peak of 649,4 ± 37.4 μ g/mL 1 h after load, followed by a rapid decrease and virtually all erythritol was eliminated after 24 h The urinary excretion rate was 80%–90% after 24 h and 72 h, respectively |
| Statistical analysis | |
| Statistical methods (including power analyses, multiple comparison, potential sources of bias, adjustment for confounders, test for interactions) | Statistical analysis was conducted with StatView II for Macintosh, and the Mann–Whitney U‐test was used as test of significant difference |
| Further information | |
| Data from this unpublished study report were subsequently published in Ishikawa et al. (1996). | |