SAFETY ASSESSMENT OF LUTEIN AND ZEAXANTHIN SUPPLEMENTATION AND ITS EFFECTS ON BLOOD GLUCOSE LEVELS, KIDNEY FUNCTIONS, LIVER FUNCTIONS AND BONE HEALTH - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY

Abstract

ABSTRACTObjectiveHbA1c, a major marker for the sugar levels in the blood, is the litmus test for people who are on the verge of entering the diabetic zone and for those who are already affected by this disease. Oral hypoglycemic agents are the fine line of treatment in such cases. Nutraceutical and herbal supplements can be utilized as a prophylactic to keep such diseases at bay. Lutein, a carotenoid from the marigold flower, is a very well-known ingredient in the management of eye health. Lutein and zeaxanthin, put together, are commonly known as macular pigments. These pigments help in filtering the blue light, thus protecting the eyes from the harmful effects of the blue light emitted from the screens of electronic gadgets. However, recent studies have demonstrated that these macular pigments have a significant effect on improving cognition and overall brain health. A randomized, double-blind, placebo-controlled clinical study was conducted on lutein and zeaxanthin to determine their effect on cognitive performance. As a safety parameter, HbA1c was also recorded during the study. At the end of the study, the statistics on the data revealed that lutein and zeaxanthin have a positive impact on HbA1c levels. It was observed that the HbA1c of the subjects in the treatment group was significantly lower than that of those in the placebo group, and the values significantly improved during the treatment duration between weeks 1 and 5. As a result, the current study examines how lutein and zeaxanthin affect type 2 diabetes mellitus (T2DM), diabetic kidney disease (DKD), non-alcoholic fatty liver disease (NAFLD), and bone health in healthy individuals between the ages of 35 and 75.MethodsThe blood parameters that were measured in thirty individuals who were randomly divided into two groups are the basis for the present study. The trial consisted of two parallel treatment groups and was randomized, double-blind, placebo-controlled clinical research. Through advertising, healthy participants between the ages of 35 and 75 were identified in the community. Following screening, 30 participants were accepted into the trial and randomly assigned using a computer-based randomization methodology into the two model groups, G1 (Group 1-treated) and G2 (Group 2-placebo). The HbA1c level for type 2 diabetes was divided into three groups based on numerical values at various levels: “improved,” “no change,” or “unfavourable.” For instance, if the levels of HbA1c decreased, they were categorized as “improved,” while if they increased, they were categorized as “unfavorable.” The safety profile of the supplement and any potential negative effects on the kidneys are evaluated using renal function testing. The tests help determine whether the supplement is altering kidney function markers such as creatinine, blood urea nitrogen, and serum urea. These factors can show whether the supplement damages the kidneys or affects their ability to function properly. After evaluating the levels of albumin, globulin, bilirubin, SGPT, SGOT, ALP, and GGTP, among various liver function markers, the effects of lutein supplementation on liver function were determined. According to a study by Takeda et al., taking lutein for four weeks significantly increased the amount of cortical bone in the femur and the overall amount of femoral bone mass. This improvement was quantified by dual X-ray absorptiometry and microcomputed tomography (CT) assessments of bone mineral density.ResultsA measure of blood sugar levels called estimated average glucose level (eAG), which is generated from HbA1c, showed similar patterns. At visit 1, the treatment group (group 1, Lutein and Zeaxanthin) reported an average eAG of 135.54, whereas the placebo group (group 2, Placebo) exhibited an eAG of 119.98. Before receiving treatment, group-1’s mean eAG was naturally higher than that of group-2. The mean BUN values at visit 1 for the treatment group (group 1, Lutein and Zeaxanthin) were 10.83, while they were 10.13 for the control group (group 2, Placebo). Groups 1 and 2 showed BUN levels of 11.03 and 10.7, respectively, during visit 5. The mean serum urea levels for groups 1 and 2 were 23.2 and 21.69, respectively. The mean values for groups 1 and 2 at visit 5 appeared to be 23.62 and 22.91, respectively, after 5 weeks. When creatinine levels were evaluated at visit 5, they were practically identical to those at visit 1 (1.02 and 0.99 mg/dL for groups 1 and 2, respectively). The mean values for creatinine during visit 1 were 1.03 and 0.985 mg/dL, respectively. At visit 1, the average albumin levels for groups 1 and 2 were 4.32 and 4.61, respectively. The albumin levels in G1 and G2 were 4.62 and 4.77 mg/dL at visit 5, after receiving therapy for 5 weeks. G1 and G2 exhibited total bilirubin levels of 0.609 and 0.547 mg/dL, respectively, during visit 1. For G1 and G2, the respective readings on the visit-5 were 0.633 and 0.662. During visit 1, the total bilirubin levels for G1 and G2 were 0.183 and 0.176 mg/dL, respectively. For G1 and G2, the respective readings during Visit-5 were 0.217 and 0.219 mg/dL. Throughout this clinical trial, there were no severe adverse effects.ConclusionClinical investigations have shown that the Lutein and Zeaxanthin is safe for bone, kidney, liver, and diabetes health. It was also noted that the Lutein supplementation helped in managing the HbA1c levels. Thus this study helps in establishing the positive effects of Lutein supplementation in people with impaired blood glucose levels.