Diet Intervention on Obesity Related Complication

NCT06719466 | Active Not Recruiting

• 1 other identifier: 20240624
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity has become a global epidemic, with more than 4 billion people expected to be overweight/obese by 2035, accounting for more than half of the world's population. Currently, there are sixteen recognized complications directly related to obesity, including gastroesophageal reflux disease. In recent years, people have increasingly paid attention to the damage caused by obesity to the stomach. In addition to gastroesophageal reflux disease, obesity also leads to various forms of gastric mucosal damage related diseases, such as gastric ulcers, chronic gastritis, intestinal metaplasia, and so on. This stuty aimed to observe the diet intervention on obesity related stomach.

Conditions

Obese; Stomach Diseases

Outcome Measures

Primary Outcomes (1)

• body weight

  stomach injury scale

  12 weeks

Secondary Outcomes (1)

• metabolic markers

  12 weeks

Study Arms (1)

linoleic acid (LA)

EXPERIMENTAL

diet intervention（diet guidance with low linoleic acid (LA) ）

Other: low linoleic acid (LA)

Interventions

low linoleic acid (LA) OTHER

diet guidance with low linoleic acid (LA) diet

linoleic acid (LA)

Eligibility Criteria

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

You may qualify if:

• Obtain informed consent before carrying out any trial-related activity, which is any procedure carried out as part of a trial, including the identification of activities suitable for the trial
• Men and premenopausal women, ages 18-65 at the time of signing the informed consent form
• Obese patients are diagnosed based on a body mass index (BMI) of 28-40kg/m2

You may not qualify if:

• ）Patients who do not possess or lose the ability to make their judgment, are unable to understand the purpose of the study, or are unwilling to cooperate with it; 2) Heart, liver, kidney dysfunction，and systemic diseases, such as various malignant tumors, systemic allergic diseases, and autoimmune diseases; 3）Drug or alcohol dependence, intellectual disability, mental disorders; 4）Pregnant and lactating women; 5) Confirmed Helicobacter pylori infection (PPI, bismuth, and antibiotics were stopped for at least 4 weeks, and any of the following tests were positive: non-invasive HP test such as urea breath test, monoclonal stool Helicobacter pylori antigen test, serum soluble Helicobacter pylori antigen test; Invasive Hp test included rapid urease test and tissue section staining); 6）diagnosis of acute gastric mucosal lesions; 7）the patient was diagnosed with chronic gastritis according to the new Sydney system visual simulation scoring method and the pathological diagnostic criteria of chronic gastritis in China; 8） histological and imaging examinations, adenocarcinoma was diagnosed.

Sponsors & Collaborators

• Zhang Manna: lead

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

MeSH Terms

Conditions

Obesity; Stomach Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: December 5, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CN (1)