- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01799720
Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)
Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial
Обзор исследования
Статус
Условия
Подробное описание
The assignment of women to distinct groups was carried out following the classification criteria established by (NCEP, 2002), and performed by the research team. Women were randomly assigned to one of three parallel groups, in a near 1:1:1 ratio. Group 1 (n=20) took two capsules per day of less oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Group 2 (n=18) consumed two capsules per day of oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Finally, group 3 (n=19) performed the diet but did not take any capsule. Therefore, the design was a single-blind (participants did not know what type of capsule they were receiving), parallel-group, randomized controlled trial conducted at the Miguel Hernández University of Elche (Spain).
Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA); likewise, significance was defined at p<0.05. Data are reported as mean standard error of the mean (SEM). Intragroup statistical comparisons were performed using the following hypothesis tests, both parametric and non-parametric: t-test, sign test and signed rank test for paired samples. Intergroup statistical comparisons were performed using the one-way analysis of variance (ANOVA) and the Kruskal-Wallis hypothesis tests. Also, Fisher least significant difference (LSD)Multiple Range Test and Tukey HSD were used in order to determine which means were significantly different from the others.
Methods for additional analyses Generalized multiple regression was used to statistically analyse the relationships between the variations in the lipid profile and the consumption of w-3 dietary supplements.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Alicante
-
Elche, Alicante, Испания, 03202
- Pharmacy Iborra Campos
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- presence of dyslipemia with no indication of drug treatment
- blood cholesterol levels ranging 250-300 mg/dL
- triglycerides (TG) 160-175 mg/dL
Exclusion Criteria:
- pregnancy
- lactation
- participation in another supplementary feeding programme
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Less oxidized oil and diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements.
For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial.
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet.
Follow-up 30 days
|
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements.
For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial.
Finally 52 women between 25 and 75 years old randomly were distributed into three groups.
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, .
Follow-up 30 days
Другие имена:
|
Экспериментальный: More oxidized oil and diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements.
For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial.
Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet .
Follow-up 30 days
|
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements.
For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial.
Finally 52 women between 25 and 75 years old randomly were distributed into three groups.
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet .
Follow-up 30 days
Другие имена:
|
Экспериментальный: Hypercholesterolemic diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements.
For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial.
Participants from group 3 only took diet and no capsules.
Follow-up 30 days
|
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements.
For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial.
Finally 52 women between 25 and 75 years old randomly were distributed into three groups.
Participants from group 3 only received the diet and no capsules.
Follow-up 30 days
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Временное ограничение: Days 1 and 30
|
In this table the investigators present the weight (kilogram) of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Временное ограничение: Days 1 and 30
|
In this table the investigators present the height of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Временное ограничение: Days 1 and 30
|
In this table the investigators present the Body Mass Index of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Временное ограничение: Days 1 and 30
|
In this table the investigators present the hip/waist ratio of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Временное ограничение: Days 1 and 30
|
In this table the investigators present the systolic pressure of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Временное ограничение: Days 1 and 30
|
In this table the investigators present the diastolic pressure of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Временное ограничение: Days 1 and 30
|
In this table the investigators present the glucose of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Временное ограничение: Days 1 and 30
|
In this table the investigators present the cholesterol of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Временное ограничение: Days 1 and 30
|
In this table the investigators present the Triglycerides (TGs) of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Временное ограничение: Days 1 and 30
|
In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
Соавторы и исследователи
Следователи
- Главный следователь: Elena García, PDI, Universidad Miguel Hernandez de Elche
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Elena García-García
- Enrique Roche Collado (Другой номер гранта/финансирования: Instituto de Salud Carlos III-FEDER PS09/01093)
- Vicente Micol Molina (Другой номер гранта/финансирования: PROMETEO/2012/007 from Generalitat Valenciana)
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. .
Клинические исследования Less oxidized oil and diet
-
Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation Trust; Rotherham Doncaster and South...ЗавершенныйТравматическое повреждение мозгаСоединенное Королевство