Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• • 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.

Locations
Other Locations
Egypt
Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility
RECRUITING
Alexandria
Contact Information
Primary
M Hany Ashour, MD Alexandria University
mohamed.ashour@alexu.edu.eg
+20 100 2600970
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2026-05
Participants
Target number of participants: 150
Treatments
Experimental: Intervention (Balance Tablet) Group
Participants take one Balance multivitamin/mineral tablet daily for 12 months. 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).
Placebo_comparator: Control (Placebo) Group
Participants take one placebo tablet daily for 12 months. The placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.
Related Therapeutic Areas
Sponsors
Leads: General Committee of Teaching Hospitals and Institutes, Egypt

This content was sourced from clinicaltrials.gov

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