Investigating the Effects of a Haskap Berry Supplement on Cognitive 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: Placebo, Pure haskap berry powder, Vitamin-and mineral-enhanced haskap berry powder.
- Кому может быть актуально
- Состояния в реестре: Cognition. Базовые параметры: от 50 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
Investigating the Cognitive, Vascular, and Metabolic Benefits of a Vitamin- and Mineral-Enhanced Haskap Berry Dietary Supplement
Обзор
This study aims to investigate the postprandial (2h) and longer term (4 week) effects of a haskap berry supplement on cognitive, vascular, and metabolic function in healthy ageing adults aged 50+.
Подробное описание
This project aims to investigate the acute benefits (during the immediate post prandial period up to 2 hours) and chronic benefits (following 4 weeks daily supplementation) of a vitamin- and mineral-enhanced haskap berry supplement made from freeze-dried, powdered haskap berries. The main objective of this study is to trial the product in older adults aged 50+ to determine any cognitive, metabolic, or cardiovascular benefits over and above haskap powder alone or a placebo powder. The study will involve a screening visit and two testing visits, 4 weeks apart. For the 24 hours prior to each test visit, participants are asked to follow a low polyphenol diet. They are requested not to consume any food or drinks except water after 8.30pm, and on the morning of test visits to only consume one slice of buttered white toast and a glass of water prior to attending the visit. During the testing visits, cognitive and mood battery tests (to include measures of memory, executive functions, and stress, will be taken at baseline, at 2 hours following the consumption of the supplement as part of a meal, and again at 4 weeks following daily consumption of the supplement added to their usual diet. Blood glucose finger pricks will be recorded at each time point along with FMD (a measure of vascular reactivity).
Вмешательства
- Пищевая добавка Placebo
6g serving of a calorie-matched powder, artificially coloured and flavoured to resemble berry powder - Пищевая добавка Pure haskap berry powder
6g serving of a pure, freeze-dried haskap berry powder - Пищевая добавка Vitamin-and mineral-enhanced haskap berry powder
6g serving of a vitamin- and mineral-enhanced haskap berry powder (fortified with potassium iodide, zinc bisglycinate, vitamin B5, and vitamin B12
Первичные конечные точки
- Delayed recall (Rey Auditory Verbal Learning Task) [Срок оценки: Baseline]
- Delayed recall (Rey Auditory Verbal Learning Task) [Срок оценки: 2 hours]
- Delayed recall (Rey Auditory Verbal Learning Task) [Срок оценки: 4 weeks]
Вторичные конечные точки (12)
- Rate of learning (Rey Auditory Verbal Learning Task) [Срок оценки: Baseline]
- Rate of learning (Rey Auditory Verbal Learning Task) [Срок оценки: 2 hours]
- Rate of learning (Rey Auditory Verbal Learning Task) [Срок оценки: 4 weeks]
- Word recognition (Rey Auditory Verbal Learning Task) [Срок оценки: Baseline]
- Word recognition (Rey Auditory Verbal Learning Task) [Срок оценки: 2 hours]
- Word recognition (Rey Auditory Verbal Learning Task) [Срок оценки: 4 weeks]
- Modified Attention Network Task (MANT) [Срок оценки: Baseline]
- Modified Attention Network Task (MANT) [Срок оценки: 2 hours]
- Modified Attention Network Task (MANT) [Срок оценки: 4 weeks]
- Task Switching Task [Срок оценки: Baseline]
- Task Switching Task [Срок оценки: 2 hours]
- Task Switching Task [Срок оценки: 4 weeks]
Критерии участия
Критерии включения
- 50+ years old
- Fruit \& veg intake less than or equal to 4 servings per day
- Adequate English language and visual \& auditory acuity to perform the cognitive tasks
- Normal BMI for age
Критерии исключения
- Being diagnosed with psychological or psychiatric disorders
- ADHD or dyslexia
- Any food allergy or intolerance
- Use of medications and dietary supplements that may impact study results
- Antibiotic use within the last 3 months
- Adherence to vegan or vegetarian diets, or other specific diets that may impact study outcomes
- Conditions altering absorption of nutrients (e.g. celiac disease)
- Being diagnosed with cardiometabolic disease (including type II diabetes and cardiovascular disease), or suffer from untreated hypertension or thrombosis related disorders
- Taking blood thinners
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
- Лечение
Центры проведения
Великобритания · 1 центр
- Nutrition, Cognition & Health Lab, School of Psychology and Clinical Language Sciences, Un — Reading
Идентификаторы
NCT: NCT07119788 · UREC 25/08 · FA2_24-11