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.
• 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.
• 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.
Parallel
Balance Tablet
DrugEach 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)
DrugThe placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.
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.
Serum nutrient levels
Changes in specific vitamin and mineral concentrations from baseline at 3, 6, 9, and 12 months. This includes vitamins B\_12, B\_1 (thiamine), B\_6 (pyridoxine), folic acid, 25-hydroxyvitamin D (25-OHD), and minerals such as iron stores (ferritin), calcium (albumin-corrected), magnesium, phosphate, zinc, as well as parathyroid hormone (PTH) and albumin (as a marker of nutritional status). For each of these analytes, the mean (or median) change over 12 months and the proportion of patients below normal range at each time point will be compared between groups.
Incidence of hypervitaminosis
Number and proportion of participants in each group who develop hypervitaminosis (excess levels of any vitamin above the normal reference range) during the 12-month period. This will be assessed at the same blood sampling intervals. Particularly, fat-soluble vitamin levels (e.g., vitamins A, D, B\_12) will be monitored for any values above the upper limit of normal.
Compliance with supplementation
Adherence to the prescribed daily tablet regimen will be evaluated utilizing the 5-item Medication Adherence Report Scale (MARS-5), a validated instrument that identifies prevalent non-adherence patterns. Each of the five items will be rated on a 5-point Likert scale from 1 (indicating 'always') to 5 (indicating 'never'), yielding a cumulative score ranging from 5 to 25, where higher scores reflect improved adherence. At each designated follow-up interval (3, 6, 9, and 12 months), a bilingual study specialist will administer the MARS-5 questionnaire orally in the participant's preferred language, either Arabic or English, and meticulously document the responses. Comparative analyses of average adherence scores will be conducted between the Balance and placebo cohorts, and we will also assess the correlation between adherence levels and the occurrence of vitamin and mineral deficiencies.
Anthropometric outcome
Changes in body weight and adiposity measure including BMI (weight and height will be combined to report BMI in kg/m\^2) at 3, 6, 9, and 12 months. That outcome will indicate the degree of weight loss and will be tracked to ensure both groups have similar weight loss (since all are on GLP-1 therapy) and to explore if improved micronutrient status correlates with better weight outcomes or vice versa. (weight in kilograms, height in meters)
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