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Идёт набор NCT07312435

B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.

Без фазы С лечением Dementia Cognitive Function

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: Intervention, Control.
Кому может быть актуально
Состояния в реестре: Dementia, Cognitive Function. Базовые параметры: от 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
Норвегия
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

B-vitamins and ω-3 Fatty Acids to Modulate Brain Ageing in European Citizens Through Improved Nutrition: the BOOMERANG Project

Обзор

A poor nutrition status is a modifiable risk factor for cognitive decline and dementia. In particular, evidence links low status of certain B-vitamins and ω-3 fatty acids (ω-3 FA) with a greater risk of cognitive decline and dementia. Although these dietary components are typically investigated separately, post-hoc analyses of existing clinical trial data and experimental work indicate that B-vitamins and ω-3 FA may exert synergistic beneficial effects on processes related to brain health and cognition. However, this combination has not been tested directly in humans. In the proposed BOOMERANG project, we will study the effects of jointly supplementing with B-vitamins and a highly bioavailable ω-3 FA supplement, Lysoveta, on a robust biomarker of brain atrophy, the neurofilament light chain, in a double-blinded randomized controlled trial (RCT) over 3 months in older adults. We will also examine the secondary effects of the supplement of quality of life and cognitive function.

Подробное описание

We will assess the effects of combined supplementation of B-vitamins and omega-3 fatty acids on neurofilament light chain (NfL), a biomarker of brain atrophy, in a group of older adults. The primary outcome is the change in plasma NfL, which is a marker related to inflammation, brain atrophy, and worsening of cognitive performance. The secondary outcomes are related to change in plasma homocysteine, B-vitamins, EPA, DHA, omega-3 index (the percentage of EPA and DHA in red blood cells), and biological age using epigenetic markers. These are biomarkers that can tell us about the effect of the supplement in the body. We also want to study the effect of the intervention on gene expression profiles and metabolite profiles. In addition, we will include secondary outcome measures of quality of life (SF-36) that include affective symptoms, as these can be a forerunner to developing cognitive impairment. We are also collecting data on their cognitive performance, as this is related to brain atrophy and neurological conditions.

Вмешательства

  • Пищевая добавка Intervention
    The intervention group will receive daily supplementation of one pill of B-vitamins (0.5 mg B12, 0.8 mg folate, 10 mg B6 and 10 mg riboflavin) + six pills of 500 mg Lysoveta, in total 3 g Lysoveta (480 mg EPA, 240 mg DHA). Lysoveta is an LPC-bound EPA/DHA supplement from krill which Aker BioMarine has recently developed.
  • Другое Control
    The control group will receive daily supplementation of one placebo pill matching the B-vitamins and one placebo pill matching Lysoveta. the placebo capsules will contain 500 mg of mixed vegetable oil (comprising a blend of olive-, maize-, and palm kernel oil and medium-chain triglycerides, in a ratio of 4:4:3:2)

Первичные конечные точки

  • Neurofilament light chain (NfL) [Срок оценки: 3 months]
Вторичные конечные точки (4)
  • Cognitive function [Срок оценки: 3 months]
  • Change in plasma homocysteine [Срок оценки: 3 months]
  • B-vitamins [Срок оценки: 3 months]
  • Omega-3 [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • Age > 65 years
  • A low baseline B-vitamin status as assessed by plasma tHcy > 11 μmol/L
  • Normal MMSE score (>25)

Критерии исключения

  • Unable to give informed consent
  • Fatty fish intake > 2 times per week
  • daily omega-3 supplementation
  • daily B-vitamin supplementation
  • history of B12-injections
  • Serum creatinine > 90 μmol/L for women and > 105 μmol/L for men (above reference values)
  • aspirin use
  • renal disease
  • active cancer
  • Participants can be included if they accept to not take omega-3 supplementation or B-vitamin supplements during the study. They should stop using it and wait 12 weeks before they are invited to a screening visit.

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
Тройное слепое
Основная цель
Профилактика

Центры проведения

Норвегия · 1 центр
  • Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo — Oslo

Идентификаторы

NCT: NCT07312435 · REK sør-øst A 912838

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗