Open Access Grey Literature

Risk Assessment of "Other Substances" – D-Glucurono-γ-lactone

Trine Husøy, Ellen Bruzell, Berit Granum, Ragna Bogen Hetland, Jens Rohloff, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 11-13
DOI: 10.9734/EJNFS/2018/38299

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present report is a risk assessment of D-glucurono-γ-lactone, and it is based on previous risk assessments. A literature search was performed, however, no articles fulfilled the inclusion criteria.

According to information from NFSA, D-glucurono-γ-lactone is an ingredient in energy drinks sold in Norway. NFSA has requested a risk assessment of 24 mg/100 ml of D-glucurono-γ-lactone in energy drinks. Drinking patterns reflecting a high acute intake, a mean chronic intake and a high chronic intake were assessed.

 

D-glucurono-γ-lactone (CAS no. 32449-92-6; EINECS no. 251-053-3) and its hydrolysis product glucuronic acid are endogenous metabolites in humans and other mammals, they occur naturally in several dietary sources and are readily metabolized to innocuous products and excreted. The estimated exposure to D-glucurono-γ-lactone from naturally occurring sources in the diet is 1-2 mg/day.

 

No human toxicity data on D-glucurono-γ-lactone was available in the included literature. A no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day, the highest dose tested, was set in 2009 by the European Food Safety Authority ( EFSA) (EFSA, 2009) based on a 13 week rat study of daily oral administration of D-glucurono-γ-lactone performed under good laboratory practice. VKM has used the NOAEL of 1000 mg/kg bw per day for the risk characterisation in the present risk assessment.

 

The risk characterisation is based on the margin of exposure (MOE) approach; the ratio of the NOAEL to the exposure. An acceptable MOE value for a NOAEL-based assessment of D-glucurono-γ-lactone is ≥100, which includes a factor 10 for extrapolation from animals to humans, and a factor 10 for interindividual human variation.

 

Due to lack of an acute reference dose or other data on acute toxicity for D-glucurono-γ-lactone, it is not possible to characterise the risk related to a high acute drinking pattern for any of the age groups.

 

For the mean chronic drinking pattern, the intake was estimated to be 58, 65, 64 and 71 ml/day for 3 to <10 year old children, 10 to <14 year old children, 14 to <18 year old adolescents and adults, respectively. With regard to the mean chronic drinking pattern, the MOE values are 1667 for the age group 3 to <10 years, 2500 for the age group 10 to <14 years, 3333 for the age group 14 to <18 and 5000 for adults ≥18 years. VKM concludes that it is unlikely that a daily mean chronic intake of D-glucurono-γ-lactone from energy drinks (containing 24 mg/100 ml) causes adverse health effects to children (3 years and above), adolescents or adults.

 

For the high chronic drinking pattern, the intake was estimated to be 163, 180, 211 and 320 ml/day for 3 to <10 year old children, 10 to <14 year old children, 14 to <18 year old adolescents and adults, respectively. With regard to the high chronic drinking pattern, the MOE values are 588 for the age group 3 to <10 years, 1000 for the age group 10 to <14 years, 1250 for the age group 14 to <18 and 909 for adults (≥18 years). VKM concludes that it is unlikely that  a daily high chronic intake of D-glucurono-γ-lactone in energy drinks (containing 24 mg/100 ml) causes adverse health effects to children (3 years and above), adolescents or adults.

Open Access Original Research Article

Formulation and Evaluation of Ready-To-Use Therapeutic Foods Using Locally Available Ingredients in Bauchi, Nigeria

Mercy Eloho Sosanya, Grace Ogechukwu Nweke, Lucy Chioma Ifitezue

European Journal of Nutrition & Food Safety, Page 1-10
DOI: 10.9734/EJNFS/2018/37833

Globally, severe acute malnutrition (SAM) is reported to affect 19 million children   0-5 years of age, and is associated with 1 to 2 million preventable child deaths every year.   60-90% of children with SAM without medical complications can be treated without being admitted to health facilities using Ready-to-use Therapeutic Food (RUTF). Shipping costs, delays & donor fatigue lead to periodical unavailability of RUTF in Nigeria, undermining its effectiveness in combating malnutrition. The aim of this study was to produce RUTF from locally available ingredients, and to determine the proximate composition and evaluate the acceptability of the RUTF. The study produced and evaluated eight samples of RUTF from locally available ingredients such as soybean, acha, (fonio), guinea corn, crayfish, peanuts, cashew nut, milk, sugar, vegetable oil and date palm, but discarded five of the samples based on costs and acceptability. Sensory evaluation of the three selected samples of RUTF (AOB, BOC and PCO) was carried out. The energy content (523kcal) of PCO, AOB (555kcal) and BOC (573kcal) were comparable to the recommendation of 520-550 kcal by the WHO. The fat contents (45.11g and 43.04g) of BOC and AOB respectively were higher, while that of PCO (32.14g) was within the recommendation of 45-60% for fat. The protein contents of AOB, BOC and PCO (22.7g, 24.11g and 21.70g respectively) were higher than the recommendation of 10-12% of energy. The ash contents (3.5g and 4.38g) of AOB and BOC were similar to that of Plumpy’Nut. BOC was the most acceptable in terms of flavour, colour and consistency.  There was no significant difference in flavour and colour (p>0.05) but there were significant differences in consistency and taste (p=0.025 and 0.008 respectively) between the samples.

Open Access Original Research Article

Determination of the Effect of Gum Arabic on Body Weight and Some Biochemical Parameters on Albino Wistar Rat

I. Y. Longdet, A. S. Eyibo, G. Istifanus, O. E. Blessing, A. D. Bogolnaan, Y. Denkok

European Journal of Nutrition & Food Safety, Page 14-19
DOI: 10.9734/EJNFS/2018/37914

This experiment studied the effect of different concentration of Gum Arabic as a supplementary diet and its effect on lipid profile, glucose level and some enzyme activity on Albino rats. Sixteen Albino rats of nine (9) weeks of age were divided into four (4) groups; each group had four (4) rats. Three (3) groups were feed with oral dose of Gum Arabic at different concentrations (200 mg/kg, 400 mg/kg, 600 mg/kg) for two (2) week and the other was used as the control. The study revealed that in serum, there was a significance at p<0.05. The significant decrease was represented in percentages for different concentration respectively as follows: Total cholesterol (7.47%, 16.16%, 35.95%), triglyceride (4.95%, 7.69%, 15.93%), High Density Lipid (HDL) (60%, 22.85%, 14.28%) as well as Low density lipid (LDL) (0%, 22.70%, 27.56%) when compared with the control, it also showed a significant result at p <0.05 for glucose level of normal rats and a reduction in body weight of the albino rats when the final body weight was compared with the initial due to the high fiber content of Gum Arabic. Gum Arabic as supplement in the diet should be done because it is rich in highly soluble fiber.

Open Access Original Research Article

The Effect on Bio-markers of Tissue Toxicity by a Low-dose Multivitamin and Mineral Supplement in Human Volunteers

Eugene Jansen, Piet Beekhof, Misha Vrolijk, Abdonas Tamosiunas, Dalia Luksiene, Migle Baceviciene

European Journal of Nutrition & Food Safety, Page 20-28
DOI: 10.9734/EJNFS/2018/38930

The benefits of multi-vitamin and mineral supplements in the (elderly) population are questioned and even adverse side effects have been reported. In the present study, the potential adverse effects of a low-dose of multivitamin and minerals is examined by a biomarker approach in young and old human volunteers. A low dose of vitamins and minerals being 100% of the recommended daily intake (RDI) of each vitamin and 18-150% of the RDI of minerals was given for one month and 2 times this dose for another month. The renal toxicity was monitored by measurement of serum of creatinine, urea and uric acid. Changes in renal biomarkers were not observed in each of the groups. Hepatotoxicity was followed by the enzymes alanine aminotransferase and aspartate aminotransferase, albumin, total cholesterol and bilirubin. The activity of alanine aminotransferase statistically significantly increased in both women groups only. In the young group, the activities increased from 15.2 IU/L to 18.1 IU/L (P = 0.102). In the older women group, the activity increased from 19.0 to 20.9 IU/L (P = 0.017). The increase in the activity of aspartate aminotransferase occurred in the two women groups as well, but the increase was only statistically significant in the older women group with a mean increase from 20.5 to 23.4 IU/L (P = 0.013). In 16% of the women, the enzyme activities were above the upper threshold value of the clinical reference range after supplementation. This finding supports the recommendation to perform more toxicity studies on supplements before marketing.

Open Access Original Research Article

Effect of Arabic Gum as Prebiotics and Lactobacillus casei Shirota (LcS) as Probiotic on Oxidative Stress and Renal Function in Adenine–Induced Chronic Renal Failure in Rats

Fadl Alla, Eman Aly Sadeek

European Journal of Nutrition & Food Safety, Page 29-46
DOI: 10.9734/EJNFS/2018/36022

Objectives: This study aimed at assessing the effect of Gum Arabic as Prebiotics and lactobacillus casei shirota (LcS) as probiotic on oxidative stress and renal function in adenine–induced chronic renal failure in rats.

Methodology: 70 male albino rats were divided into 7 groups and treated for 8 weeks as follows group 1: control basal diet group (BD), group 2: adenine in feed (0.75%, w/w), group 3: gum Arabic (GA) in drinking water (15%, w/v), group 4: lactobacillus casei shirota (LcS) 1 x 109 colony-forming units (CFU) supplement, group 5 adenine + GA, as before, group 6 adenine +(LcS) as before and group 7: adenine + GA+ (LcS) as before. Urine, blood and kidneys were collected from the rats at the end of the treatment for analysis of conventional renal function tests serum creatinine, urea, uric acid, sodium, potassium concentration). In addition, the oxidative stress markers serum and kidney glutathione and superoxide dismutase, serum catalase and malondialdhyde (MDA) were measured.

Results: By the end of the 8 weeks of treatment, Adenine significantly (p <0.05) increased the concentrations of serum creatinine, urea, uric acid, sodium, potassium and serum MDA. In addition, the oxidative stress markers serum and kidney glutathione and superoxide dismutase, serum catalase was, significantly decreased.

Treatment with (GA) and (LcS) significantly ameliorated these actions. The mechanism of the reported salutary effect of GA in adenine-induced CRF is associated with mitigation of the adenine- induced inflammation and generation of free radicals.

Conclusion: The results suggest that that oral administration of gum Arabic and lactobacillus casei shirota could conceivably alleviate adverse effects of adenine induced renal toxicity (CRF).