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Study aim
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The Efficacy of the Herbal Supplement Nutrition Bio-Shield (NBS) Superfood in Improving Nutritional, Clinical, and Laboratory Outcomes in Patients After Bariatric Surgery: A Double-Blind Clinical Trial
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Design
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This is a phase 1-2 randomized, double-blind, parallel-group, controlled clinical trial conducted on 66 patients. Randomization was performed using the RAND function in Microsoft Excel.
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Settings and conduct
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Investigators, nurses, and statisticians are blinded to the group allocation of patients. This clinical trial will be conducted in university hospitals in Tehran. The intervention group (33 patients) will receive NBS powder for 6 months in addition to the routine treatment prescribed by the attending physician. The control group (33 patients) will receive the same treatment plan along with a placebo for 6 months. Demographic and laboratory parameters specified in this study will be collected and recorded for all patients before and after the intervention. Finally, statistical methods will be used to analyze the significance of the results.
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Participants/Inclusion and exclusion criteria
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Patients of all ages were enrolled immediately after bariatric surgery if they had a body mass index (BMI) above 40 kg per m² or a BMI above 35 kg per m² with one or more significant comorbidities. A recent history of medication use, including corticosteroids, NSAIDs, benzodiazepines, and others, was considered a primary exclusion criterion for participation in the study.
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Intervention groups
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The intervention group will receive 4.5 grams of NBS powder daily, divided into three doses of 1.5 grams, for a duration of 6 months alongside standard treatment. The control group will also receive the standard treatment plan along with a placebo.
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Main outcome variables
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Serum Levels of Micronutrients, Serum Inflammatory Markers, Lipid Profile, Liver and Kidney Function Assessment, Blood Glucose Levels