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
Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss
General Committee of Teaching Hospitals and Institutes, Egypt
150 participants
May 15, 2025
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria3
- Adults aged 18-65 years.
- BMI ≥ 30 kg/m² (obesity), or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension).
- Currently using a GLP-1 receptor agonist medication for weight management (e.g., semaglutide or liraglutide) and planning to continue it for the next year as part of their weight loss regimen.
Exclusion Criteria5
- Any pre-existing condition that affects nutrient absorption or metabolism (e.g., malabsorptive gastrointestinal disorders such as celiac disease or inflammatory bowel disease, prior bariatric surgery).
- Use of other weight loss medications (besides the GLP-1 RA) or use of high-dose vitamin/mineral supplements or other nutritional supplements that could influence vitamin/mineral status.
- Pregnancy or lactation (women of childbearing potential will undergo a pregnancy test and must agree to use contraception during the study).
- Known hypersensitivity or allergy to components of the Balance multivitamin formulation.
- Significant chronic illnesses (e.g., end-stage renal disease, advanced liver disease) that in the investigator's judgment would interfere with participation or outcomes of the study.
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Interventions
Each Balance tablet contains a broad range of vitamins and trace minerals at doses designed to prevent deficiencies (including but not limited to vitamins A, B-complex, C, D, E, K, calcium, iron, zinc, magnesium, selenium, and others, per standard multivitamin composition).
The placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06981936