Меню
Идёт набор NCT06991296

Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After n-3 PUFA Supplementation.

Без фазы С лечением Obesity

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: SPM Active®.
Кому может быть актуально
Состояния в реестре: Obesity. Базовые параметры: 45 лет — 60 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After Supplementation With "SPM Active®".

Обзор

The goal of this clinical trial is to learn if daily supplementation with SPM Active® can increase omega 3 polyunsaturated fatty acid derivatives and improve well-being in adults with obesity. The main questions it aims to answer are: Does 2 g/day of SPM Active® for 12 weeks increase plasma levels of 14-hydroxydocosahexaenoic (HDHA), 17-HDHA, and 18-hydroxy eicosapentaenoic acid (HEPE)? Does 2 g/day of SPM Active® for 12 weeks improve self-reported burnout, life satisfaction, and sleep quality? Participants will: Take two SPM Active® soft-gel capsules daily for 12 weeks (±2-4 days). Provide 12-hour fasting blood samples before and after the intervention. Complete validated surveys on burnout, life satisfaction, and sleep quality at baseline and study end.

Подробное описание

Purpose: This study aims to explore the effects of 'SPM Active®,' an omega-3 polyunsaturated fatty acid (n-3 PUFA) dietary supplement, on male adults with obesity. The supplement specifically targets the increase of monohydroxylated derivatives of n-3 PUFAs, which play a crucial role in reducing chronic, low-grade inflammation. The primary objective of the study is to determine whether administering SPM Active® at 2g/day for a longer duration (3 months) leads to higher levels of the monohydroxylated derivatives (14-HDHA, 17-HDHA, and 18-HEPE) in adults with obesity (BMI between 30 and 40 kg/m\^2, n=33). The secondary objective is to evaluate whether administration of SPM Active® improves the following outcomes: a) burnout, b) life satisfaction, and c) sleep quality. These outcomes will be assessed using validated surveys administered before and after the intervention.

Participants: The study will include 33 healthy male and female participants of any ethnicity, aged 45-60 years, with a BMI of 30-40 kg/m\^2.

Procedures: The intervention involves the administration of the dietary supplement 'SPM Active®' provided by Metagenics. All participants will take 2 soft gel capsules per day for 12 weeks, with a window of +/- 2-4 days. A 12-hour fasting blood sample will be collected from each participant before and after the intervention by a licensed phlebotomist at the UNC Nutrition Research Institute (NRI) at Kannapolis, NC. Additionally, participants will complete surveys at the start and end of the study.

Вмешательства

  • Пищевая добавка SPM Active®
    Participants will take two SPM Active® soft-gel capsules orally each day (total 2 g/day of specialized pro-resolving mediators) for 12 weeks (± 2-4 days). Capsules are provided by Metagenics and contain monohydroxylated n-3 PUFA derivatives (14-HDHA, 17-HDHA, 18-HEPE).

Первичные конечные точки

  • Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE) [Срок оценки: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)]
Вторичные конечные точки (3)
  • Change in Burnout Score [Срок оценки: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)]
  • Change in Life Satisfaction Score [Срок оценки: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)]
  • Change in Sleep Quality Score [Срок оценки: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)]

Критерии участия

Критерии включения

  • adults, ages 45-60 years
  • Body mass index (BMI) between 30 and 40 kg/m\^2
  • Any race or ethnicity

Критерии исключения

  • Age < 45 years or > 60 years
  • pregnant or breastfeeding women
  • BMI < 30 kg/m\^2 or > 40 kg/m\^2
  • Diagnosed type 1 or type 2 diabetes
  • Active autoimmune disease, liver disease, coagulopathy, or hypothyroidism
  • Known allergy to fish or shellfish
  • Current use of any of the following medications: asthma controller therapies, anticoagulants, estrogen or testosterone, daily aspirin or NSAIDs.
  • Inability to give informed consent
  • Receiving immunomodulatory or immunosuppressant therapy
  • Known active malignancy or undergoing treatment for malignancy
  • Use of n-3 PUFA supplements or high consumption of fatty fish (> 2 servings/week) within 3 months prior to enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • UNC Nutrition Research Institute — Kannapolis

Идентификаторы

NCT: NCT06991296 · 24-0328

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗