Micronutrient deficiencies in GLP-1 receptor agonist users Nutritional status during GLP-1 therapy Vitamin and mineral levels during weight loss with GLP-1 medications Nutritional deficiencies associated with GLP-1 treatment Micronutrient status during semaglutide therapy Micronutrient Levels in GLP-1
Conditions
Interventions
The investigational product in this study is the Support-1 multivitamin supplement by Fit for Me (Rotterdam, the Netherlands), a comprehensive multivitamin and mineral formulation designed to provide
Sponsors
WeightWorks Clinics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 18-70Start with the use of Tirzepatide as GLP-1 receptor agonists and for at least 3 months with stable dosing before randomization. BMI =30 kg/m² or =27 kg/m² with obesity-associated medical problems (such as type 2 diabetes, hypertension, or dyslipidemia) at the start of GLP-1 therapyWilling and able to provide informed consentAble to comply with study procedures and follow-up visitsOwn vitamins should be completely discontinued 2 weeks before the start
Exclusion criteria
Exclusion criteria: Known allergy or hypersensitivity to any components of the multivitamin supplementCurrent use of other vitamin or mineral supplementsPregnancy or planning pregnancy during the study periodActive malignancy or ongoing cancer treatmentSevere kidney disease (eGFR <30 mL/min/1.73m²)Severe liver disease (Child-Pugh C)History of metabolic bariatric surgeryPatients who follow a vegan diet. Participation in other clinical trials within the past 3 monthsAny condition that, in the investigator's opinion, would interfere with study participation or compromise patient safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study are the differences in serum levels of three key micronutrients between Group A (multivitamin supplementation) and Group B (placebo) after 12 months of intervention:Vitamin B12 (Reference range: 200-500 pmol/L)Vitamin D (Reference range: 50-200 nmol/L)Ferritin (Reference range: 30-388 µg/L)Folic acid (Reference range: 10-45 nmol/L)The sample size calculation is based on detecting a difference in Ferritin levels between the supplement group (expected mean: 145 µg/L) and the placebo group (expected mean: 128 µg/L), with a pooled standard deviation of 40 µg/L in both groups. This yields a Cohen's d effect size of 0.39. Using a two-sided t-test with 80% power (ß = 0.2) and a significance level of 5% (a = 0.05), 106 patients per group are required for equal allocation. Accounting for an anticipated dropout rate of 15%, a total of 246 patients (123 per group) will be recruited.The primary analysis will employ mixed-effects models to account for repeated measures over time, with treatment group, time, and their interaction as fixed effects, and subject as a random effect. Statistical significance will be set at a = 0.05, with appropriate adjustment for multiple comparisons for secondary outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: Changes in other micronutrient levels from baseline to 12 months, including:Iron (10-30 µmol/L) Vitamin B1 (70-180 nmol/L)Vitamin B6 (35-110 nmol/L)Zinc (10-18 µmol/L)Magnesium (0.70-1.05 mmol/L)Calcium: Total serum calcium: 2.15-2.55 mmol/L)Ionized calcium: 1.16-1.32 mmol/L Transferrin (2.0-3.6 g/L)Transferrin saturation (20-45%)Total iron binding capacityChanges in hematological parameters:Hemoglobin (Female: 7.5-10.0 mmol/L; Male: 8.5-11.0 mmol/L)Mean Corpuscular Volume (MCV) (80-100 fL)HbA1c (4.0-6.0% (20-42 mmol/mol))Inflammation and protein statusC-reactive protein (CRP): <10 mg/LAlbumin: 35-50 g/L Incidence of clinically significant deficiencies requiring interventionCorrelation between weight loss parameters (%TWL, %EWL) and changes in micronutrient levelsPTH (Parathyroid Hormone) (1.6-6.9 pmol/L)Changes in additional iron-related functional markers:Other study parametersOther parameters to be assessed include:1. Weight and BMI changes throughout the study period Weight, height, waist circumference, and BMI at baseline, 3, 6, 9, and 12 months2. Body composition assessment (bioelectrical impedance analysis) Measured at baseline, 6 months, and 12 monthsParameters: fat mass, fat-free mass, muscle mass, visceral fat3. Resting Energy Expenditure (REE) Measured via indirect calorimetry at baseline, 6 months, and 12 months4. Nutritional assessment and intake patterns Comprehensive 3-day food diaries at baseline, 3, 6, 9, and 12 monthsFood Frequency Questionnaire (FFQ) at baseline, 6, and 12 months5. Self-reported adherence to GLP-1 therapy and study medication Medication adherence questionnaire at each visitVisual analogue scale for appetite and satietyGLP-1 side effect monitoring6. Quality of life measuresOBESI-Q questionnaire (version 2.0) at baseline, 6 months, and 12 months - a validated quality of life instrument specifically designed for patients with morbid obesity undergoing weigh | — |
Countries
Netherlands
Contacts
Public ContactB Torensma
WeightWorks Clinics
Outcome results
None listed