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Идёт набор NCT07130513

Investigating the Feasibility of Krill Oil Intervention to Improve Muscle Function in Adults With Long-term Conditions

Без фазы С лечением Krill Oil Muscle Function Grip Strength Long-Term Conditions

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: Krill oil supplementation, Control.
Кому может быть актуально
Состояния в реестре: Krill Oil, Muscle Function, Grip Strength, Long-Term Conditions. Базовые параметры: от 18 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
Великобритания
Следующий шаг
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Официальное название

The Effect of Krill Oil Supplementation on Muscle Function in Adults With High-risk Long-term Conditions: a Randomized Controlled Pilot Study.

Обзор

This study will recruit 30 adults (men and women, aged 18 years and over) who will be randomly assigned to one of two groups in a 12-week double-blind pilot trial. Participants will receive either: * Arm 1: Krill Oil group: 4 g/day of krill oil supplements (Superba™ Antarctic Krill Oil, 1000 mg capsules), or * Arm 2: Control group: 4 g/day of placebo (vegetable oil capsules). Participants will be instructed to maintain their usual diet and physical activity patterns throughout the study. Eligibility will be assessed using a health screening questionnaire, completed with the researcher's assistance, before obtaining informed consent. Habitual physical activity will be evaluated using the International Physical Activity Questionnaire (short form), and dietary intake will be assessed with the EPIC Food Frequency Questionnaire (FFQ) at both the beginning and end of the study. In addition, participants will record their fish consumption weekly using a dedicated logbook. Measurements will be taken at baseline and after 12 weeks, including: * Blood samples to assess inflammatory and metabolic markers. * Anthropometry and body composition, including weight, height, fat mass, fat percentage, and muscle mass (via ultrasound). * Muscle strength, measured using handgrip strength and maximal voluntary contraction (each performed three times with rest between attempts). * Physical performance, assessed with a 4-meter walk test at normal speed Upon completing the study, participants will receive a £50 voucher in appreciation of their contribution.

Вмешательства

  • Пищевая добавка Krill oil supplementation
    Krill oil supplementation program providing 4 g/day of krill oil (Superba™ Antarctic Krill Oil, 1000 mg capsules) for 12 weeks.
  • Пищевая добавка Control
    Vegetable oil supplementation (4 g/day)

Первичные конечные точки

  • Grip strength [Срок оценки: Changes from baseline to week 12]
Вторичные конечные точки (11)
  • Knee extendor Strength [Срок оценки: Changes from baseline to week 12]
  • Muscle size, assessed as vastus lateralis muscle thickness by ultrasound [Срок оценки: Changes from baseline to week 12]
  • Gait speed [Срок оценки: From baseline to week 12]
  • Fatty Acid Composition [Срок оценки: From baseline to week 12]
  • Inflammatory and metabolic markers [Срок оценки: From baseline to week 12]
  • Height [Срок оценки: Changes from baseline to week 12]
  • Bodyweight [Срок оценки: Changes from baseline to week 12]
  • Body Mass Index (BMI) [Срок оценки: Changes from baseline to week 12]
  • Body Fat Mass [Срок оценки: Changes from baseline to week 12]
  • Body Fat Percentages [Срок оценки: Changes from baseline to week 12]
  • Fat Free Mass [Срок оценки: Changes from baseline to week 12]

Критерии участия

Критерии включения

  • Men and women aged ≥18 years who are in the high-risk long-term condition group (having one or more LTCs, including rheumatoid arthritis, gout, type 2 diabetes, coronary heart disease, and stroke \[including transient ischemic attack, TIA\]).

Критерии исключения

  • Participants are diagnosed with and being treated for any type of cancer.
  • Presence of neurocognitive disorders or any health condition affecting memory (e.g., Alzheimer's disease, dementia).
  • Aortic stenosis, history of haemorrhagic stroke, or presence of aneurysms.
  • Current anticoagulant therapy.
  • Use of any muscle mass supplements or presence of physiological conditions such as pregnancy or breastfeeding.
  • History of allergy to fish or fish oil.
  • Regular consumption of more than one portion of oily fish per week, or use of fish oil or krill oil supplements.

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Великобритания · 2 центра
  • Lab 242, Sir James Black Building, University of Glasgow — Glasgow
  • University of Glasgow — Glasgow

Идентификаторы

NCT: NCT07130513 · KOMM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗