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.
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.
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
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.
- Conditions
- Obesity, Bariatric Surgery, Nutritional Status, Body Composition
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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.
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.
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.
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
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.
- First posted8 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Safina Tanveer, Khyber Teaching Hospital
- Investigators
- Safina Tanveer, MBBS, FCPS-II, Principal investigator, Khyber Teaching Hospital
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