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ObesityNCT07111767

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

A study testing Low-Cost Post-Bariatric Diet and Standard High-cost Post-Bariatric Diet in people with Obesity and Bariatric Surgery, run by Khyber Teaching Hospital at 1 site in Pakistan.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Bariatric Surgery, Nutritional Status
What is being tested?
Low-Cost Post-Bariatric Diet and Standard High-cost Post-Bariatric Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 sitePakistan
Study dates
Oct 2025to Jun 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Safina Tanveer, MBBS,FCPS-II training contact

0092 337 6919129

safina.tanveer@kth.edu.pk

Pakistan1 site
  • Khyber Teaching Hospital

    Peshawar, Khyber Pakhtun Khwa, 25210

    Safina Tanveer, MBBS, FCPS-II in process, 0092 337 6919129, safina.tanveer@kth.edu.pk

    Safina Tanveer, MBBS, FCPS-II in process

Other trials in Pakistan

About this study

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.

Read the detailed description

Obesity is a growing global health problem and is recognized by the World Health Organization (WHO) as a leading cause of preventable disease. It is a complex, long-term condition influenced by multiple factors, and treatment options range from lifestyle changes to medications and surgery. Bariatric surgery is currently the most effective long-term treatment for morbid obesity. It not only helps in significant weight loss but also improves obesity-related health problems such as type II diabetes, hypertension, and obstructive sleep apnea, while improving quality of life.

Among the various surgical techniques, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and one-anastomosis gastric bypass (OAGB/MGB) are the most commonly performed. However, these surgeries can lead to reduced absorption of essential nutrients because they bypass parts of the intestine where vitamins and minerals are absorbed. Nutrient deficiencies, particularly in vitamin B12, iron, and vitamin D, are common after bariatric surgery. Therefore, structured dietary management and supplementation are essential after surgery to prevent these deficiencies and preserve lean body mass (LBM).

Standard dietary recommendations from the American Society for Metabolic and Bariatric Surgery (ASMBS) suggest a gradual progression from liquids to solid foods, adequate protein intake (1.0-1.5 g/kg), and lifelong use of vitamin and mineral supplements. However, in countries like Pakistan, where 45% of the population lives below the international poverty line, the standard postoperative diet often includes costly imported supplements like whey protein, which are unaffordable and hard to access for most patients, particularly those from rural areas. This creates barriers to dietary compliance and worsens clinical outcomes.

Adequate protein intake plays a key role in preserving lean body mass and improving recovery after bariatric surgery. Nutritional deficiencies, particularly in vitamin B12, iron, and vitamin D, remain prevalent after bariatric surgery and require targeted nutritional strategies.

In response to these challenges, this study introduces a low-cost dietary plan based on ASMBS guidelines using locally available, affordable foods to meet protein and micronutrient needs. It aims to compare this plan with the conventional high-cost hospital diet to determine whether it can effectively promote weight loss, maintain lean body mass, and prevent micronutrient deficiencies. By aligning with international standards while addressing local socioeconomic constraints, this approach could improve patient adherence, nutritional outcomes, and overall recovery following bariatric surgery.

Being tested
Low-Cost Post-Bariatric Diet, Standard High-cost Post-Bariatric Diet
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
Medical subject headings
Obesity, Vitamin B 12 Deficiency, Iron Deficiencies, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-Cost Post-Bariatric DietDietary 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.

  • Standard High-cost Post-Bariatric DietDietary 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.

Study groups in NCT07111767
Study groupRoleWhat they receive
Experimental Arm: Cost-effective Post-Operative dietExperimentalParticipants 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.
Receives: Dietary Supplement: Low-Cost Post-Bariatric Diet
Control - Standard High-Cost Postoperative DietActive comparatorParticipants 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.
Receives: Dietary Supplement: Standard High-cost Post-Bariatric Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (5)
  1. 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.

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

  2. Change in Serum Vitamin B12 Levels

    Measured via serum vitamin B12 assay.Levels below 200 pg/mL will be considered deficient.

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

  3. 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.

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

  4. 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)

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

  5. Body Mass Index (BMI)

    BMI will be calculated by dividing weight (kg) by height squared (m²). Height will be measured only at baseline, as it remains unchanged postoperatively. Follow-up BMI will be derived using baseline height and follow-up weight measurements.Unit of Measure: kg/m²

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07111767
Sponsor's protocol ID
661/DME/KMC
Status last verified
Aug 2025
First submitted
28 Jul 2025
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28718091

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