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

NCT06981936 | Recruiting Phase 4

• 1 other identifier: Balance tablets And GLP1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Micronutrient Deficiencies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of vitamin and mineral deficiencies at 12 months, comparing the proportion of participants in each group who develop one or more deficiencies.

  Deficiency is defined for each nutrient as a serum concentration below the lower limit of the normal reference range (see Definitions below). The incidence of deficiencies will also be measured at interim time points (3, 6, and 9 months) to observe the trajectory over time, but the comparison at 12 months is the primary endpoint for efficacy.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (6)

• Serum nutrient levels

  From enrollment to the end of treatment at 12 months

• Incidence of hypervitaminosis

  From enrollment to the end of treatment at 12 months

• Compliance with supplementation

  From enrollment to the end of treatment at 12 months

• Anthropometric outcome

  From enrollment to the end of treatment at 12 months

• Anthropometric outcome

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Intervention (Balance Tablet) Group

EXPERIMENTAL

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).

Drug: Balance Tablet

Control (Placebo) Group

PLACEBO COMPARATOR

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.

Drug: Control (placebo)

Interventions

Balance Tablet DRUG

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).

Intervention (Balance Tablet) Group

Control (placebo) DRUG

The placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.

Control (Placebo) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

M Hany Ashour, MD Alexandria University

CONTACT

+20 100 2600970; mohamed.ashour@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery, Surgeon

Model Details: Participants will be randomly assigned to one of two intervention arms: * 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). * 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. * All participants will continue their prescribed GLP-1 RA therapy and any standard dietary advice for weight loss as per their treating provider. Compliance will be encouraged through monthly reminders and pill count checks; participants will be asked to return unused tablets at each study visit to monitor adherence.

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 21, 2025
• Study Start: May 15, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Whole study period
• Access Criteria: Ask contact person

Locations

EG (1)