Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)
2015年7月12日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
71
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alicante
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Elche、Alicante、スペイン、03202
- Pharmacy Iborra Campos
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
25年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
|
|
実験的：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
他の名前：
|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
時間枠：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.
|
Days 1 and 30
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
時間枠：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
|
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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).
時間枠：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
|
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Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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.
|
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).
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Elena García, PDI、Universidad Miguel Hernandez de Elche
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年10月1日
一次修了 (実際)
2011年2月1日
研究の完了 (実際)
2011年4月1日
試験登録日
最初に提出
2013年2月19日
QC基準を満たした最初の提出物
2013年2月25日
最初の投稿 (見積もり)
2013年2月27日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年8月3日
QC基準を満たした最後の更新が送信されました
2015年7月12日
最終確認日
2015年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Elena García-García
- Enrique Roche Collado (その他の助成金/資金番号：Instituto de Salud Carlos III-FEDER PS09/01093)
- Vicente Micol Molina (その他の助成金/資金番号：PROMETEO/2012/007 from Generalitat Valenciana)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。