GLP - 1, Nutritional Deficiencies, Obese Patients, Weight Loss
Conditions
Keywords
weightloss, obesity, GLP-1, Nutritional deficiencies
Brief summary
Rationale: Glucagon-Like Peptide-1 (GLP-1) receptor agonists have emerged as effective treatments for obesity and associated medical conditions. However, patients may be at risk of micronutrient deficiencies during therapy due to reduced appetite, altered gastrointestinal physiology, and weight loss. Multivitamin supplementation is commonly prescribed to mitigate these risks, but the necessity and efficacy of multivitamin use in GLP-1 users remain debatable, as some clinicians advocate for routine supplementation while others do not. Objective: To assess the differences in micronutrient levels between patients who use multivitamin supplements while on GLP-1 therapy and those who do not, to provide evidence on the necessity and benefits of supplementation. Study Design: Randomized, double-blind, placebo-controlled trial. Study Population: Adults with obesity (BMI ≥30 kg/m² or ≥27 kg/m² with obesity-associated medical problems) currently using GLP-1 receptor agonists for at least 3 months with stable dosing. Intervention: * Group A (Intervention): Multivitamin supplementation while on GLP-1 therapy * Group B (Control): Matching placebo while on GLP-1 therapy Main Study Parameters/Endpoints: The primary outcomes are the differences in serum levels of Vitamin B12, Vitamin D, and Ferritin between the multivitamin and placebo groups after 12 months of supplementation while on GLP-1 therapy. Nature and Extent of the Burden and Risks: Participants will undergo blood sampling at four timepoints: baseline (before starting GLP-1 therapy), at randomization (3 months of stable GLP-1 therapy), and at 6 and 12 months post-randomization. The risks associated with the study are minimal and primarily related to blood sampling and potential side effects of multivitamin supplementation. The burden includes time commitment for study visits and daily supplement intake.
Interventions
DIETARY_SUPPLEMENTMultivitamin Supplementation
Multivitamin Supplementation
OTHERPlacebo
Placebo vitamine
Sponsors
weightworks Clinic
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 to 70 years. * Start with the use of Tirzepatide 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 therapy * Willing and able to provide informed consent * Able to comply with study procedures and follow-up visits * Own vitamins should be completely discontinued 2 weeks before the start
Exclusion criteria
* Known allergy or hypersensitivity to any components of the multivitamin supplement * Current use of other vitamin or mineral supplements * Pregnancy or planning pregnancy during the study period * Patients who follow a vegan diet. * Active malignancy or ongoing cancer treatment * Severe kidney disease (eGFR \<30 mL/min/1.73m²) * Severe liver disease (Child-Pugh C) * History of metabolic bariatric surgery * Participation in other clinical trials within the past 3 months * Any condition that, in the investigator's opinion, would interfere with study participation or compromise patient safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum levels | 15 months | 1. Vitamin B12 (Reference range: 200-500 pmol/L) 2. Vitamin D (Reference range: 50-200 nmol/L) 3. Ferritin (Reference range: 30-388 μg/L) 4. Folic acid (Reference range: 10-45 nmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| other micronutrient levels | 12 months | 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 PTH (Parathyroid Hormone) (1.6-6.9 pmol/L) Changes in additional iron-related functional markers: * Transferrin (2.0-3.6 g/L) * Transferrin saturation (20-45%) * Total iron binding capacity 2. Changes 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 status * C-reactive protein (CRP): \<10 mg/L * Albumin: 35-50 g/L Incidence of clinically significant deficiencies requiring intervention Correlation between weight loss parameters (%TWL, %EWL) and changes in micronutrient levels |
Other
| Measure | Time frame | Description |
|---|---|---|
| diet | 12 months | Dietary intake patterns (assessed through food frequency questionnaires) |
| QoL | 12 months | Quality of life measures |
| Weight loss | 12 months | Weight and BMI changes throughout the study period |
| Resting Energy Expenditure (REE) | 12 months | Measured via indirect calorimetry |
| Body composition assessment | 12 months | * Measured at baseline, 6 months, and 12 months * Parameters: fat mass, fat-free mass, muscle mass, visceral fat |
| GLP adherence | 12 months | Adherence to GLP-1 therapy and study medication |
Countries
Netherlands
Outcome results
None listed