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Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk (FitALA)

21 июля 2017 г. обновлено: Manja Zec, University of Belgrade

Investigation of Health Effects of Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk Towards Established and Molecular Cardiovascular Risk Factors

This cross-over study investigates health effects of dietary intake of whole walnuts towards cardiovascular risk factors in adults under low cardiovascular risk.

Investigators hypothesize that daily intake of whole nuts as a replacement meal, would improve cardiovascular risk factors, including traditional risk factors and molecular biomarkers.

The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.

The study subjects are instructed to continue with their habitual diet and physical activity.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

Recent literature data raise important questions on the beneficial effect of dietary fats. Dietary intake of nuts, although with high caloric burden, is however characterized with high intake of fatty acids with known beneficial health effects. Those fatty acids include mono- (MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are ascribed.

Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA, especially content of alpha-linolenic PUFA, considered essential fatty acid, since not synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be inversely related with cardiovascular risk factors, both in interventional studies and epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional, and includes the action itself, as well as beneficial endogenous conversion towards long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.

Although high caloric intake is indicated with intake of walnuts, literature data suggest that consumption of walnuts does not increase body weight.

Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and apolipoproteins in adult population. Also, consumption of walnuts was associated with decrease in blood pressure.

The study design is cross-over, controlled, randomized nutritional intervention. The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.

The study subjects are instructed to continue with their habitual diet and physical activity. Additionally, study subjects are instructed to avoid walnuts and nuts other then study treatment, during the complete study period of 10 weeks.

Sample size calculation was conducted by use of online calculators, and was based on the low density lipoprotein (LDL) cholesterol. Namely, in order to achieve decrease in 0.5 mmol/L, in a sample with projected standard deviation of 0.7 mmol/L, and type I and II errors being 0.2 and 0.05, respectively, 62 subjects are needed.

Тип исследования

Интервенционный

Регистрация (Действительный)

52

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Сербия
      • Belgrade, Сербия, 11000
        • Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 30 лет до 70 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

Presence of at least one of the following criteria, formerly assessed through routine medical examination:

  • dyslipidemia, defined as the presence of either: elevated total cholesterol (>5.2 mmoL/L), and/or elevated LDL-cholesterol (>3.4 mmoL/L), and/or elevated triglycerides (>1.7 mmoL/L), and/or decreased HDL-cholesterol (<1.6 mmoL/L)
  • elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular anti-hypertension therapy

Exclusion Criteria:

  • presence of allergy on any nuts
  • presence of any chronic disease, excluding following conditions: hypertension and diabetes mellitus type 2
  • smoking
  • statin therapy
  • pregnancy and/or lactation

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Walnut

At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).

Treatment arm includes 56 g of whole walnuts daily.
Диетическая добавка: Whole Walnuts
Intervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner. Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so. Walnuts are provided with the same producer at the Belgrade market.
Без вмешательства: Control
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Changes in LDL-cholesterol
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in Systolic Blood Pressure
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in Diastolic Blood Pressure
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Changes in HDL-cholesterol
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in HDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in total cholesterol
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in total cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in triglycerides
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in triglycerides measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in glucose metabolism biomarkers
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in glucose biomarkers measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in renal function parameters
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in renal function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in liver function parameters
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in liver function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in body weight
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in waist circumference
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in waist circumference, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in percent of total body fat
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in percent of total body fat measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Level of Physical Activity
Временное ограничение: Baseline
Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.
Baseline
Psychological parameters
Временное ограничение: 5 weeks
Psychological parameters are assessed by use of standardized questionnaire for self-assessment of psychological implications of daily activities related to cardiovascular health .
5 weeks
Changes in hematological parameters
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in hematological, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in number of leukocyte cells
Временное ограничение: Baseline, 5 weeks, 10 weeks
Changes in number of leukocyte cells, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in total caloric intake
Временное ограничение: Baseline, 5 weeks, 10 weeks

Changes in total caloric intake, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

Total caloric intake is measured by use of standardized dietary questionnaire namely 24-hour Dietary Recall.
Baseline, 5 weeks, 10 weeks
Changes in caloric intake of fats
Временное ограничение: Baseline, 5 weeks, 10 weeks

Changes in caloric intake of fats, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Baseline, 5 weeks, 10 weeks
Changes in caloric intake of carbohydrates
Временное ограничение: Baseline, 5 weeks, 10 weeks

Changes in caloric intake of carbohydrates, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Baseline, 5 weeks, 10 weeks
Changes in caloric intake of vitamin D
Временное ограничение: Baseline, 5 weeks, 10 weeks

Changes in caloric intake of vitamin D, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Baseline, 5 weeks, 10 weeks

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Belgrade

Соавторы

Centre of Research Excellence in Nutrition and Metabolism

Следователи

  • Главный следователь: Maria Glibetic, Prof, Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

21 апреля 2017 г.

Первичное завершение (Действительный)

15 июля 2017 г.

Завершение исследования (Действительный)

15 июля 2017 г.

Даты регистрации исследования

Первый отправленный

17 июля 2017 г.

Впервые представлено, что соответствует критериям контроля качества

21 июля 2017 г.

Первый опубликованный (Действительный)

24 июля 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

24 июля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 июля 2017 г.

Последняя проверка

1 июля 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • EO120/2017

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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