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Safety and Efficacy of Multi-Fiber Complex Nutrient (Type II) Special Diet for Long-Term Weight Management in Overweight/Obese Patients Complicated with Gastroesophageal Reflux Disease

Safety and Efficacy of Multi-Fiber Complex Nutrient (Type II) Special Diet for Long-Term Weight Management in Overweight/Obese Patients Complicated with Gastroesophageal Reflux Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124835
Enrollment
Unknown
Registered
2026-05-18
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overweight

Interventions

Multi-Fiber Complex Nutrient (Type II) Special Diet Group:Multi-Fiber Complex Nutrient (Type II) Special Diet
Individualized Dietary Intervention Group:Individualized Dietary Intervention
Standard Lifestyle Intervention Group:Standard Lifestyle Intervention

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, both male and female are eligible. 2. Clinically diagnosed with GERD, meeting any one of the following: (1) Endoscopy within 6 months prior to enrollment confirms reflux esophagitis (LA grade A or above); (2) Esophageal reflux monitoring within 6 months prior to enrollment confirms acid exposure time > 6%; (3) Presence of typical GERD symptoms (occurring >=2 times per week) with a symptom improvement rate >=50% after at least 2 weeks of standard-dose PPI treatment (i.e., positive PPI test). 3. Clinically diagnosed with overweight/obesity: (1) Overweight: 24 kg/m^2 = 28 kg/m^2. 4. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.Presence of severe organic upper gastrointestinal diseases, such as esophageal stricture, peptic ulcer, or tumor; 2.History of prior gastric or esophageal surgery; 3.Concomitant severe cardiac, hepatic, or renal insufficiency; 4.Presence of poorly controlled thyroid dysfunction, diabetes mellitus, or other diseases that severely affect metabolism; 5.Hypersensitivity to any component of Multi-Fiber Complex Nutrient (Type II) Special Diet; 6.Pregnant or lactating women; 7.Participation in other clinical trials within 1 month prior to enrollment; 8.Other conditions deemed unsuitable for inclusion in this study by the investigators.

Design outcomes

Primary

MeasureTime frame
Reflux Disease Questionnaire;—

Secondary

MeasureTime frame
Body Weight;Esophageal Mucosal Injury Status;Incidence of Adverse Events;Dosage and Frequency of Acid-Suppressive Medication Use;Gastroesophageal Reflux Disease Questionnaire;Body Mass Index (BMI);Waist Circumference;Waist-to-Hip Ratio (WHR);—

Countries

China

Contacts

Public ContactLiansong Ye

West China Hospital of Sichuan University

yeliansongnj@wchscu.cn+86 28 8542 2552

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026