Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)
12 juli 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
71
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alicante
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Elche, Alicante, Spanje, 03202
- Pharmacy Iborra Campos
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
25 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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
Andere namen:
|
|
Experimenteel: 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
Andere namen:
|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Tijdsspanne: 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).
Tijdsspanne: 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)
Tijdsspanne: Days 1 and 30
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In this table the investigators present the hip/waist ratio of the three intervented groups.
Data are mean ± sem.
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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).
Tijdsspanne: Days 1 and 30
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In this table the investigators present the systolic pressure of the three intervented groups.
Data are mean ± sem.
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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).
Tijdsspanne: Days 1 and 30
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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).
Tijdsspanne: Days 1 and 30
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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).
Tijdsspanne: Days 1 and 30
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In this table the investigators present the cholesterol of the three intervented groups.
Data are mean ± sem.
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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).
Tijdsspanne: 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).
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Elena García, PDI, Universidad Miguel Hernandez de Elche
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2010
Primaire voltooiing (Werkelijk)
1 februari 2011
Studie voltooiing (Werkelijk)
1 april 2011
Studieregistratiedata
Eerst ingediend
19 februari 2013
Eerst ingediend dat voldeed aan de QC-criteria
25 februari 2013
Eerst geplaatst (Schatting)
27 februari 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
3 augustus 2015
Laatste update ingediend die voldeed aan QC-criteria
12 juli 2015
Laatst geverifieerd
1 juli 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Elena García-García
- Enrique Roche Collado (Ander subsidie-/financieringsnummer: Instituto de Salud Carlos III-FEDER PS09/01093)
- Vicente Micol Molina (Ander subsidie-/financieringsnummer: PROMETEO/2012/007 from Generalitat Valenciana)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .