Diet Intervention on Obesity Related Complication

the Effect of Diet Intervention on Obesity

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stomach Diseases; Obese
• Intervention / Treatment: Other: low linoleic acid (LA)

Detailed Description

Western foods high in fat, sugar, fiber and additives can lead to a series of health problems, ultimately leading to obesity and obesity-related complications. The gastrointestinal tract is directly connected to the outside world, so its influence on dietary factors cannot be underestimated. In recent years, the intake of ω-6 polyunsaturated fatty acids (ω-6 PUFAs) in the Western diet is 10-20 times higher than the normal range, of which the seriously excessive linoleic acid (LA) is also getting more and more attention

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200072
    • Department of Endocrinology, Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Men and premenopausal women, ages 18-65 at the time of signing the informed consent form
3. Obese patients are diagnosed based on a body mass index (BMI) of 28-40kg/m2

Exclusion Criteria:

1）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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: linoleic acid (LA); diet intervention（diet guidance with low linoleic acid (LA) ）	Other: low linoleic acid (LA); diet guidance with low linoleic acid (LA) diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	stomach injury scale	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
metabolic markers	change in body weight and metabolic markers	12 weeks

Collaborators and Investigators

• Sponsor: Zhang Manna

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases
• Other Study ID Numbers: 20240624

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No