This study will see if a low-cost dietary plan, based on the standard dietary guidelines of the American Society for Metabolic and Bariatric Surgery (ASMBS) and using locally available foods, can help patients lose weight and keep their lean body mass after bariatric surgery. It will also check if this plan can maintain healthy levels of important nutrients such as vitamin B12, iron, and vitamin D.
Patients who have undergone bariatric surgery will be randomly assigned to follow either the low-cost diet or the regular hospital diet. Their weight, body composition, and nutrient levels will be tracked at baseline, and at 1, 3, and 6 months after surgery.
The aim is to find out if this simpler, affordable diet, which follows international standards, works as well as the regular plan while being easier for low-income patients to follow.
Able to give informed written consent
Adults between the ages of 18 and 65 undergoing primary bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy, or OAGB)
Patients having revision bariatric surgery
Patients with recognized diseases related to micronutrient supplementation
Patients with pre-existing gastrointestinal, metabolic, or endocrine disorders that impair nutrient absorption
Parallel
Low-Cost Post-Bariatric Diet
Dietary supplementLow-Cost Post-Bariatric Diet (Experimental): Based on the American Society for Metabolic and Bariatric Surgery (ASMBS) guidelines. Uses affordable, locally available foods (e.g., eggs, lentils, local dairy products) to meet protein and micronutrient needs. Designed to be cost-effective and accessible for patients from low-income or rural areas.
Standard High-cost Post-Bariatric Diet
Dietary supplementStandard Post-Bariatric Diet (Active Comparator): The conventional high-cost diet currently followed at the study hospital. Includes imported or expensive protein supplements such as whey protein and cottage cheese, along with nutritional products not easily accessible in rural or low-resource settings.
Weight Loss
Weight loss will be measured using a calibrated digital weighing scale.Weight loss will be defined as the reduction in body weight (kg) from baseline. Unit of Measure: Kilograms (kg)
Change in Serum Iron Levels
Hemoglobin (g/dL) and serum ferritin (ng/mL) measured via blood tests.Iron deficiency will be defined as Hb \<12 g/dL (women) or \<13 g/dL (men) and/or ferritin \<15 ng/mL.
Change in Serum Vitamin B12 Levels
Measured via serum vitamin B12 assay.Levels below 200 pg/mL will be considered deficient.
Change in Serum Vitamin D Levels
Serum 25(OH) vitamin D (ng/mL) measured via blood assay . Levels below 20 ng/mL will be considered deficient.
Lean Body Mass (LBM)
Change in lean body mass assessed using bioelectrical impedance analysis to evaluate preservation of lean tissue after bariatric surgery. Unit of Measure: Kilograms (kg)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
