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Идёт набор NCT07133477

A Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function

Без фазы С лечением Skin Health

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: Omega 3-9-11, Placebo.
Кому может быть актуально
Состояния в реестре: Skin Health. Базовые параметры: 35 лет — 65 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomised, Placebo-Controlled Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function

Обзор

The primary objective of the study is to determine the benefits of the food product EPAX Omega 3-9-11 on skin function. Benefits (if any) will be determined by evaluating biophysical measurements of the face and inner forearm. Moreover, the study will determine the dosage effect of Omega-3-9-11 on these measurements.

Подробное описание

The long chain mono-unsaturated fatty acids, cetoleic acid (C22:1 n-11) and gondoic acid (C20:1 n-9) found in some North Atlantic fish have been shown to lower inflammatory markers. This has been shown in preclinical studies with particular effect in adipose tissue, and in a human clinical study measuring redness of the face. Omega-3 is also known for reducing skin erythema evoked as a response to UVB exposure, and to decreasing systemic inflammatory biomarkers.

This provides a hypothesis that a combination oil with known bioaccumulation in both subcutaneous fat and in dermal/epidermal layers will contribute to healthy skin function, as shown by a reduction in inflammatory markers and skin erythema and improved barrier function.

The study will recruit subjects to one of 3 arms, a placebo, a low dose and a high dose of omega 3-9-11. Subjects will receive capsules for 3 months and undergo a series of measurements at baseline, 6 weeks and 12 weeks.

Вмешательства

  • Пищевая добавка Omega 3-9-11
    Fish oil capsules containing a fish oil concentrate from North Atlantic fish species containing EPA / DHA / cetoleic acid and gondoic in controlled amounts.
  • Пищевая добавка Placebo
    Corn oil capsules

Первичные конечные точки

  • Erythema [Срок оценки: 3 months intervention]
  • Skin hydration [Срок оценки: 3 months intervention]
Вторичные конечные точки (2)
  • Skin parameters, placebo adjusted [Срок оценки: 3 months intervention]
  • Skin health by Omega-3 index [Срок оценки: 3 months intervention]

Критерии участия

Критерии включения

  • Volunteers who are able to provide signed informed consent
  • Healthy male or female volunteers between the ages of 35 and 65 years
  • Volunteers with a self-perceived history of atopic skin, prone to redness and/or dryness

Критерии исключения

  • Females who are pregnant, breast feeding, or have given birth within the previous 6 weeks or are planning to be pregnant during the study
  • Volunteers with previous experience of intolerance or allergic reactions to fish or fish products
  • Volunteers with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of a trained assessor or dermatologist may affect the test results
  • Volunteers currently taking or who have recently taken antihistamines, antibiotics, systemic anti-inflammatory drugs during the previous week
  • Volunteers currently taking or who have recently taken retinoids, immunosuppressive drugs, anti-cancer drugs during the six previous months
  • Volunteers who have started, stopped or changed hormonal treatment (including contraceptive pills) in the five previous weeks
  • Volunteers whose skin has been exposed to excessive levels of sun or UV rays during the previous month
  • Volunteers who are suffering from chronic asthma, a malfunction of the lymphatic system, or an auto immune deficiency disease (e.g. lupus, thyroiditis)
  • Volunteers with a history of skin tumours or malignant disease
  • Volunteers who have participated in any clinical study involving the test sites within the previous month
  • Volunteers taking fish oil supplements or other lipid-based supplements regularly during the last 4 weeks

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Другое

Центры проведения

Великобритания · 1 центр
  • Cutest Systems Ltd — Cardiff

Идентификаторы

NCT: NCT07133477 · AN3991

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗