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Набор по приглашению NCT07634133

The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte Membranes

Без фазы С лечением Healthy Volunteers

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: EPA/DHA supplements, ALA supplements, Placebo supplements.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers. Базовые параметры: 18 лет — 60 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
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

The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte and Neuromuscular System in Athletes

Обзор

Therefore, the aim of our project will be to assess the impact of omega-3 fatty acid on the neuromuscular system (muscle tensomyography- TMG), the composition and fluidity of erythrocyte cell membranes, the lipid profile and the antioxidant status of the blood.

Подробное описание

The ability of skeletal muscles to generate force and resist fatigue is essential for athletic performance. Training adaptations within the neuromuscular system and skeletal muscles modulate the muscles' ability to produce force and resistance to fatigue. Much research has been conducted to determine the effects of dietary supplements on skeletal muscle adaptation to strength training (e.g., protein supplementation) and methods to support endurance performance (e.g., carbohydrate loading). However, limited research has been conducted to date on the effects of dietary supplements on the neuromuscular system.The research will focus on the effect of 4 and 8 weeks of supplementation with high doses of omega 3 fatty acids on the level of omega 3/omega6 fatty acids, the level of TRANS fatty acids and AA (arachidonic acid) fatty acid using a mixed diet. Additionally, we will examine the effect of this supplementation on the neuromuscular system (muscle tensomyography -TMG), the composition and fluidity of erythrocyte cell membranes, the lipid profile and the antioxidant status of the blood. The research will use innovative assumptions - high doses of omega 3 fatty acids. Additionally, a new laboratory tool will be used to assess the level of individual fatty acids (omega 3, omega 6) in the blood, the level of which shows or excludes latent inflammation in the body.

Вмешательства

  • Пищевая добавка EPA/DHA supplements
    The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Each capsule will contain 330mg EPA and 220mgDHA.
  • Пищевая добавка ALA supplements
    The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Daily dose will contain 3500mg ALA.
  • Пищевая добавка Placebo supplements
    The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. One capsule will contain 550 mg of olive oil. The placebo will be matched to the supplement in appearance.

Первичные конечные точки

  • Omega 3 index [Срок оценки: 4-weeks]
Вторичные конечные точки (4)
  • Tensiomyography (TMG) Parameters [Срок оценки: 4-weeks]
  • Corsi Block-Tapping Test - Unweighted Block Span [Срок оценки: 4-weeks]
  • Corsi Block-Tapping Test - Block Time [Срок оценки: 4 weeks]
  • Corsi Block-Tapping Test - Reverse Span Score [Срок оценки: 4 weeks]

Критерии участия

\*\*Inclusion Criteria:\*\*

  • Male participants aged 20-40 years.
  • Apparently healthy individuals, as determined by medical history and self-reported health status.
  • Physically active, engaging in regular physical activity at least 3 times per week for the previous 6 months.
  • Following a mixed diet.
  • Willingness to maintain habitual dietary and physical activity patterns throughout the study.
  • Willingness to refrain from consuming dietary supplements other than those provided as part of the study.

\*\*Exclusion Criteria:\*\*

  • Current use of dietary supplements within 4 weeks prior to enrollment.
  • Following a low-carbohydrate, ketogenic, high-carbohydrate, vegetarian, or vegan diet.
  • Presence of gastrointestinal disorders affecting nutrient absorption, including irritable bowel syndrome, inflammatory bowel disease, celiac disease, or other clinically significant gastrointestinal conditions.
  • History of cardiovascular, metabolic, endocrine, hepatic, renal, neurological, or autoimmune diseases.
  • Current use of medications known to affect lipid metabolism, inflammation, antioxidant status, or cognitive function.
  • Known allergy or intolerance to study supplements or their ingredients.
  • Participation in another clinical trial within the previous 3 months.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Польша · 1 центр
  • Academy of Physical Education in Katowice — Katowice

Идентификаторы

NCT: NCT07634133 · 4-II/2024 · 2024/53/B/NZ7/02257 · RID/SP/0053/2024/01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗