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Active, Not Recruiting

NCT Number: NCT06719466

Diet Intervention on Obesity Related Complication

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, 200072, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

low linoleic acid (LA)

Other

diet guidance with low linoleic acid (LA) diet

Primary outcomes

  1. body weight

    Time frame: 12 weeks

    stomach injury scale

Secondary outcomes

  1. metabolic markers

    Time frame: 12 weeks

    change in body weight and metabolic markers

Sponsors and collaborators

Lead sponsor

Zhang Manna

Other

Registry information

Official study title

the Effect of Diet Intervention on Obesity

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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