This Randomized Trial Aims to Investigate the Efficacy of Balanced Nutritional Tablets-Comprehensive Multivitamin and Mineral Supplements- in Preventing Micronutrient Deficiencies Among Patients Utilizing GLP-1 RAs for Weight Loss in Comparison to a Placebo Control

Micronutrient Deficiencies

Balance Tablets, Vitamin and Mineral Deficiencies, GLP-1 Receptor Agonists for Weight Loss, Weight Loss, Micronutrient Deficiencies

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including Ozempic (semaglutide) and Saxenda (liraglutide), are gaining traction in treating obesity and its associated diseases due to their capacity to facilitate substantial weight loss through mechanisms such as appetite suppression and delayed gastric emptying. Clinical trials have consistently shown that patients prescribed GLP-1 RAs can achieve significant body weight reductions when combined with appropriate dosing and lifestyle modifications. However, the chronic appetite suppression and reduced caloric intake associated with prolonged GLP-1 RA use may increase the risk of micronutrient deficiencies, paralleling the biochemical changes observed after metabolic and bariatric surgery (MBS). In MBS cohorts, insufficient dietary intake coupled with malabsorption frequently results in deficiencies of essential vitamins and minerals, even in patients adhering to standard multivitamin regimens. Research has demonstrated that high-dose specialized multivitamin supplementation can substantially lower the incidence of postoperative micronutrient deficiencies in MBS patients. This raises the possibility that proactive nutrient supplementation might similarly benefit individuals undergoing weight loss with GLP-1 RAs, although this hypothesis remains to be empirically validated. To address this gap, this randomized trial aims to investigate the efficacy of Balanced nutritional tablets-comprehensive multivitamin and mineral supplements- in preventing micronutrient deficiencies among patients utilizing GLP-1 RAs for weight loss in comparison to a placebo control. Moreover, the study will assess changes in key nutrient biomarkers and relevant clinical outcomes over 12 months.

Primary Objectives: • Evaluate the efficacy of daily Balance multivitamin tablets in reducing the incidence of vitamin and mineral deficiencies among patients undergoing treatment with GLP-1 receptor agonists (RAs) for weight loss over 12 months, in comparison to a placebo group. Secondary Objectives: * Assessment of changes in serum concentrations of key vitamins and minerals such as vitamin B12, 25-hydroxyvitamin D, ferritin, and folate. * comparing data collected at baseline with that gathered at the 12-month mark between the Balance multivitamin and placebo groups. * Evaluate the effects of the intervention on body weight and various anthropometric measures, including Body Mass Index (BMI), percent excess weight loss (%EWL), and percent total body weight loss (%TWL), over the same 12-month period. * Investigate the occurrence of hypervitaminosis, defined as elevated vitamin levels above normal ranges, within both intervention groups. * Monitor adherence to the daily tablet regimen, ensuring compliance with the intervention protocol throughout the study duration. Definitions * Vitamin/Mineral Deficiency: For the purpose of this study, a deficiency is defined as a serum concentration below the lower limit of the standard laboratory reference range for that nutrient. Each participating laboratory will have established normal ranges for the measured vitamins and minerals; values below the 2.5th percentile of healthy individuals (the typical lower limit) will be considered deficient. For example, vitamin B\_12 deficiency may be defined as B\_12 \< 200 pg/mL and vitamin D deficiency as 25-OHD \< 20 ng/mL, based on commonly accepted thresholds, although the exact cut-off will depend on the assay reference range . Participants will be considered to have a deficiency if any one or more of the tracked nutrients falls below the normal range at a given time point (excluding transient lab errors, which would be rechecked). Each distinct nutrient deficiency will also be recorded for analysis. * Hypervitaminosis: Defined as a serum vitamin level above the upper limit of the normal reference range. For instance, vitamin B\_6 above \ 30 ng/mL or 25-OHD above \ 100 ng/mL (depending on lab norms) would be flagged as potential hypervitaminosis. Any participant with a value above the normal range for a given vitamin at any time is noted as having hypervitaminosis (for that vitamin). The study intervention (Balance tablets) is formulated at standard recommended doses, so true hypervitaminosis is expected to be rare; however, tracking this ensures safety. If any levels are extremely high (e.g., \>2 times upper limit), study clinicians will be notified to evaluate the participant for over-supplementation or other causes.

No related papers found yet.

Egypt