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| ID | Type | Description | Link |
|---|---|---|---|
| ABR 2025 GLP | Other Identifier | The Netherlands Medical Research Portal (CCMO) |
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| Name | Class |
|---|---|
| weightworks Clinic | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Multivitamin Supplementation) | Experimental | Participants in this group will receive a daily multivitamin supplement formulated to provide comprehensive micronutrient support. The supplement will be taken once daily with a meal for the 12-month intervention period following randomization. |
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| Group B (Placebo) | Placebo Comparator | Participants in this group will receive a matching placebo that is identical in appearance, taste, and packaging to the active multivitamin supplement. The placebo will be taken once daily with a meal for the 12-month intervention period following randomization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivitamin Supplementation | Dietary Supplement | Multivitamin Supplementation |
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| Measure | Description | Time Frame |
|---|---|---|
| serum levels |
| 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| other micronutrient levels | Changes in other micronutrient levels from baseline to 12 months, including:
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:
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| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Weight and BMI changes throughout the study period | 12 months |
| GLP adherence | Adherence to GLP-1 therapy and study medication | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WeightWorks Clinics | Amersfoort | Netherlands | ||||
| Erasmus MC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38454010 | Result | Bettadapura S, Dowling K, Jablon K, Al-Humadi AW, le Roux CW. Changes in food preferences and ingestive behaviors after glucagon-like peptide-1 analog treatment: techniques and opportunities. Int J Obes (Lond). 2025 Mar;49(3):418-426. doi: 10.1038/s41366-024-01500-y. Epub 2024 Mar 7. | |
| 33269530 | Result | Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3. |
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The investigator will be responsible for the data analysis. The analysis will be performed on a blinded data set after medical/scientific review has been completed, all protocol violations have been identified, and the data set has been declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com) and performed according to Good Clinical Practice guidelines, Data Protection Directive certificate and complies with Title 21 CFR Part 11. Furthermore, the datacenter where all the research data is stored is ISO27001, ISO9001 certified and the Dutch NEN7510 certified.
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D044342 | Malnutrition |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Other | Placebo vitamine |
|
| 12 months |
| diet | Dietary intake patterns (assessed through food frequency questionnaires) | 12 months |
| QoL | Quality of life measures | 12 months |
| Body composition assessment |
| 12 months |
| Resting Energy Expenditure (REE) | Measured via indirect calorimetry | 12 months |
| Rotterdam |
| Netherlands |
| 39295512 | Result | Mechanick JI, Butsch WS, Christensen SM, Hamdy O, Li Z, Prado CM, Heymsfield SB. Strategies for minimizing muscle loss during use of incretin-mimetic drugs for treatment of obesity. Obes Rev. 2025 Jan;26(1):e13841. doi: 10.1111/obr.13841. Epub 2024 Sep 19. |
| 39040467 | Result | He L, Li Q, Yang Y, Li J, Luo W, Huang Y, Zhong X. Pharmacovigilance study of GLP-1 receptor agonists for metabolic and nutritional adverse events. Front Pharmacol. 2024 Jul 8;15:1416985. doi: 10.3389/fphar.2024.1416985. eCollection 2024. |
| 36568085 | Result | Liu L, Chen J, Wang L, Chen C, Chen L. Association between different GLP-1 receptor agonists and gastrointestinal adverse reactions: A real-world disproportionality study based on FDA adverse event reporting system database. Front Endocrinol (Lausanne). 2022 Dec 7;13:1043789. doi: 10.3389/fendo.2022.1043789. eCollection 2022. |
| 31565876 | Result | Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ. A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans. Endocrinol Metab (Seoul). 2019 Sep;34(3):247-262. doi: 10.3803/EnM.2019.34.3.247. |
| 39722834 | Result | Gentinetta S, Sottotetti F, Manuelli M, Cena H. Dietary Recommendations for the Management of Gastrointestinal Symptoms in Patients Treated with GLP-1 Receptor Agonist. Diabetes Metab Syndr Obes. 2024 Dec 19;17:4817-4824. doi: 10.2147/DMSO.S494919. eCollection 2024. |
| 39175746 | Result | Christensen S, Robinson K, Thomas S, Williams DR. Dietary intake by patients taking GLP-1 and dual GIP/GLP-1 receptor agonists: A narrative review and discussion of research needs. Obes Pillars. 2024 Jul 25;11:100121. doi: 10.1016/j.obpill.2024.100121. eCollection 2024 Sep. |
| 39892489 | Result | Moiz A, Filion KB, Tsoukas MA, Yu OH, Peters TM, Eisenberg MJ. Mechanisms of GLP-1 Receptor Agonist-Induced Weight Loss: A Review of Central and Peripheral Pathways in Appetite and Energy Regulation. Am J Med. 2025 Jun;138(6):934-940. doi: 10.1016/j.amjmed.2025.01.021. Epub 2025 Jan 31. |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |