Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06981936

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

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here