Improvement of Fish Oil in Obesity With Mild Cognitive Impairment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Fish oil intervention, Placebo intervention.
- Кому может быть актуально
- Состояния в реестре: Obesity, Mild Cognitive Impairment. Базовые параметры: 35 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Mechanisms of n-3 Polyunsaturated Fatty Acids Promoting White Fat Beige Coloration to Improve Obesity With Cognitive Impairment by Regulating Intestinal Bacteriophages and Their Metabolites
Обзор
Eighty-eight patients with obesity with mild cognitive impairment（MCI） from the Multicenter Nutrition and Chronic Disease Cohort, who met the inclusion and exclusion criteria, were selected as study subjects and randomly divided into 2 groups, i.e., the placebo group and the n-3 PUFA intervention group. Subjects in the intervention group were given supplemental n-3 PUFA (supplied in 1.36 g fish oil capsules); the placebo group took placebo (1.36 g/d), and the intervention period was 12 consecutive months. General information, dietary intake, body composition, exercise, overall cognitive function and multidimensional cognitive function, abundance of Mycobacterium avium and its metabolites acetic acid and propionic acid content, beige adiposity markers, inflammation-related factors, and lipid metabolism were collected at baseline, at the end of 6 months and at the end of 12 months of the intervention, respectively, and the adherence of the two groups of subjects was also assessed. To analyze the effects of n-3 PUFA intervention on cognitive function in patients with obesity with MCI and to explore the possible mechanisms.
Вмешательства
- Пищевая добавка Fish oil intervention
The diet was based on the principles of a balanced diet, and subjects in this group were additionally supplemented with n-3 PUFA (provided as 1.36 g fish oil capsules), with the rest of the intervention being the same as in the control group. - Другое Placebo intervention
Diet based on the principles of a balanced diet, taking placebo capsules with the same appearance and odor as the fish oil capsules.
Первичные конечные точки
- Height, Waist [Срок оценки: Baseline, 6 months, 12 months]
- weight [Срок оценки: Baseline, 6 months, 12 months]
- Total Body Water [Срок оценки: Baseline, 6 months, 12 months]
- body protein, inorganic salts, and body fat [Срок оценки: Baseline, 6 months, 12 months]
- Appendicular skeletal muscle mass index [Срок оценки: Baseline, 6 months, 12 months]
- Cognitive function assessment [Срок оценки: Baseline, 6 months, 12 months]
- Dietary composition [Срок оценки: Baseline]
- Dietary Inflammation Index [Срок оценки: Baseline]
- Species and abundance of intestinal flora [Срок оценки: Baseline, 6 months, 12 months]
- Metabolite levels of intestinal flora [Срок оценки: Baseline, 6 months, 12 months]
Вторичные конечные точки (2)
- Blood lipids [Срок оценки: Baseline, 6 months, 12 months]
- Fasting blood glucose [Срок оценки: Baseline, 6 months, 12 months]
Критерии участия
Критерии включения
- Meet the diagnostic criteria of obesity and MCI;
- Age between 35 and 80 years old;
- No dieting or stop dieting in the last 3 months, no fish oil supplements, or willing to stop self-administration of fish oil 3 months before the intervention;
- Voluntarily participate in the program with informed consent, and sign the informed consent form.
Критерии исключения
- Those with neuropsychiatric disorders such as stroke, epilepsy, or schizophrenia;
- Those with cognitive impairment caused by depression, thyroid disease, traumatic brain injury, drug or alcohol intoxication;
- Those with a history of cerebrovascular disease or cognitive impairment caused by severe cardiac, hepatic, pulmonary, or renal impairment;
- Those who are complete vegetarians and are unable to comply with the balanced dietary pattern;
- Those who suffer from severe angina pectoris, asthmatic bronchitis, severe infections , systemic lupus erythematosus, malignant tumors, and other diseases that may affect one's dietary habits and life;
- Coeliac disease with lipid malabsorption.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Профилактика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06992726 · Z2023SY126