Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)
12 lipca 2015 zaktualizowane przez: Elena García García, Universidad Miguel Hernandez de Elche
Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial
The oxidation level of unsaturated fatty acid supplements commercialized in capsules could be a serious problem for manufacturers and a risk to consumers; health by ingesting substances whose effects are not desired.
Therefore, the main objective of this paper is to 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 the investigators have designed a single-blind, parallel-groups, randomized controlled trial.
Finally, 52 women between 25 and 75 years old were randomly distributed into three groups: (1) took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, (2) took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet and (3) no capsules, only received the diet.
There was a 30 days follow-up .
All groups followed a low cholesterol diet.
Circulating glucose, total cholesterol, triglycerides and glutamic pyruvic transaminase were determined at the beginning and end of a 30 day period.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
71
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Alicante
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Elche, Alicante, Hiszpania, 03202
- Pharmacy Iborra Campos
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
25 lat do 75 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
|
|
Eksperymentalny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Ramy czasowe: Days 1 and 30
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In this table the investigators present the weight (kilogram) of the three intervented groups.
Data are mean ± sem.
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Days 1 and 30
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Ramy czasowe: Days 1 and 30
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In this table the investigators present the height of the three intervented groups.
Data are mean ± sem.
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Days 1 and 30
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Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Ramy czasowe: Days 1 and 30
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In this table the investigators present the Body Mass Index of the three intervented groups.
Data are mean ± sem.
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Days 1 and 30
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Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Ramy czasowe: 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
|
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Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Ramy czasowe: 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
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Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Ramy czasowe: 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
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Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Ramy czasowe: 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
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Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Ramy czasowe: 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
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Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Ramy czasowe: Days 1 and 30
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In this table the investigators present the Triglycerides (TGs) of the three intervented groups.
Data are mean ± sem.
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Days 1 and 30
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Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Ramy czasowe: Days 1 and 30
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In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups.
Data are mean ± sem.
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Days 1 and 30
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Elena García, PDI, Universidad Miguel Hernandez de Elche
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 października 2010
Zakończenie podstawowe (Rzeczywisty)
1 lutego 2011
Ukończenie studiów (Rzeczywisty)
1 kwietnia 2011
Daty rejestracji na studia
Pierwszy przesłany
19 lutego 2013
Pierwszy przesłany, który spełnia kryteria kontroli jakości
25 lutego 2013
Pierwszy wysłany (Oszacować)
27 lutego 2013
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
3 sierpnia 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
12 lipca 2015
Ostatnia weryfikacja
1 lipca 2015
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Elena García-García
- Enrique Roche Collado (Inny numer grantu/finansowania: Instituto de Salud Carlos III-FEDER PS09/01093)
- Vicente Micol Molina (Inny numer grantu/finansowania: PROMETEO/2012/007 from Generalitat Valenciana)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .