Effectiveness of a Modified Cost-Effective Dietary Plan in Promoting Weight Loss and Preservation of Lean Body Mass in Patients After Bariatric Surgery

NCT07111767 | Not Yet Recruiting DMC

• 1 other identifier: 661/DME/KMC
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Bariatric Surgery; Nutritional Status; Body Composition

Keywords

Bariatric surgery; Obesity management; Post-bariatric diet; Cost-effective diet; Low-cost diet plan; Vitamin B12 deficiency; Iron deficiency; Vitamin D deficiency; Weight loss after bariatric surgery; Lean body mass preservation

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline, 1 month, 3 months, and 6 months after surgery.

Secondary Outcomes (5)

• Change in Serum Iron Levels

  Baseline, 1 month, 3 months, and 6 months post-surgery.

• Change in Serum Vitamin B12 Levels

  Baseline, 1 month, 3 months, and 6 months post-surgery.

• Change in Serum Vitamin D Levels

  Baseline, 1 months, 3 months, and 6 months post-surgery.

• Lean Body Mass (LBM)

  Baseline, 1 month, 3 months, and 6 months postoperatively

• Body Mass Index (BMI)

  Baseline, 1 month, 3 months, and 6 months postoperatively

Study Arms (2)

Experimental Arm: Cost-effective Post-Operative diet

EXPERIMENTAL

Participants in this arm will follow a low-cost dietary plan designed according to the American Society for Metabolic and Bariatric Surgery (ASMBS) guidelines, using locally available, affordable foods to meet protein and micronutrient needs. The plan aims to promote weight loss, preserve lean body mass, and prevent nutrient deficiencies.

Dietary Supplement: Low-Cost Post-Bariatric Diet

Control - Standard High-Cost Postoperative Diet

ACTIVE COMPARATOR

Participants in this arm will follow the standard postoperative hospital diet, which includes expensive protein supplements (e.g., whey protein, cottage cheese) and imported nutritional products typically recommended after bariatric surgery.

Dietary Supplement: Standard High-cost Post-Bariatric Diet

Interventions

Low-Cost Post-Bariatric Diet DIETARY_SUPPLEMENT

Low-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.

Experimental Arm: Cost-effective Post-Operative diet

Standard High-cost Post-Bariatric Diet DIETARY_SUPPLEMENT

Standard 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.

Control - Standard High-Cost Postoperative Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber Teaching Hospital

Peshawar, Khyber Pakhtun Khwa, 25210, Pakistan

Location

Related Publications (1)

• Via MA, Mechanick JI. Nutritional and Micronutrient Care of Bariatric Surgery Patients: Current Evidence Update. Curr Obes Rep. 2017 Sep;6(3):286-296. doi: 10.1007/s13679-017-0271-x.

  PMID: 28718091 BACKGROUND

Related Links

• Evidence-based guidelines from ASMBS on nutritional and micronutrient management for bariatric surgery patients, including dietary progression, protein intake, and supplementation strategies.

MeSH Terms

Conditions

Obesity; Vitamin B 12 Deficiency; Iron Deficiencies; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Iron Metabolism Disorders; Metabolic Diseases

Study Officials

• Safina Tanveer, MBBS, FCPS-II

  Khyber Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Safina Tanveer, MBBS,FCPS-II training

CONTACT

0092 337 6919129; safina.tanveer@kth.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR| Trainee Medical Officer

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 8, 2025
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)