Actively Recruiting
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
Led by General Committee of Teaching Hospitals and Institutes, Egypt · Updated on 2025-09-16
150
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years
- BMI of 30 kg/m² or higher, or BMI of 27 kg/m² or higher with at least one obesity-related condition such as type 2 diabetes or hypertension
- Currently using a GLP-1 receptor agonist medication for weight management and planning to continue for the next year
You will not qualify if you...
- Any condition affecting nutrient absorption or metabolism, including malabsorptive gastrointestinal disorders like celiac disease or inflammatory bowel disease, or prior bariatric surgery
- Use of other weight loss medications besides GLP-1 receptor agonists or use of high-dose vitamin/mineral or other nutritional supplements that could affect vitamin/mineral status
- Pregnancy or lactation; women of childbearing potential must agree to contraception during the study
- Known allergy or hypersensitivity to any component of the Balance multivitamin
- Significant chronic illnesses such as end-stage kidney disease or advanced liver disease that might interfere with study participation or outcomes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility
Alexandria, Egypt
Actively Recruiting
Research Team
M
M Hany Ashour, MD Alexandria University
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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