Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile (cereals)
Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial
調査の概要
詳細な説明
The investigators performed an intervention including 133 women (age 25-70 years). Participants were randomly and single-blind distributed into three groups: Group 1 (n=38) consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and glucose were determined at the beginning and end of a 30-day test.
Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data are reported as mean ± standard error of the mean (sem). Intra-group 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. Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and Tukey's honestly significant difference (HSD) were used in order to determine which means were significantly different from the others. In addition, Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Alicante
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Elche、Alicante、スペイン、03202
- Pharmacy Iborra Campos
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- voluntarily participation
- ages between 25-70 years
- undergoing dyslipidemia
- with no pharmacological treatment
- cholesterol (250-300 mg/dL)
- triglycerides (160-175 mg/dL)
Exclusion Criteria:
- subjects undergoing any pharmacological treatment that may influence lipid metabolism
- lipid levels outside the range of those specified in the inclusion criteria
- subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
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実験的：Cereals
For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.
The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day).
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The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37).
For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.
他の名前：
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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 |
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Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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Circulating parameters of cholesterol total
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30 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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In this table the investigators present the weight of the three intervented groups
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30 days
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Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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Circulating parameters of cholesterol HDL
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30 days
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Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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Circulating parameters of cholesterol LDL
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30 days
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Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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Circulating parameters of triglycerides
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30 days
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Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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Circulating parameters of glucose
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30 days
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BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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In this table the investigators present the BMI of the three intervented groups
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30 days
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Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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In this table the investigators present the hip / waist measure of the three intervented groups
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30 days
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Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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In this table the investigators present the systolic pressure of the three intervented groups
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30 days
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Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
時間枠：30 days
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In this table the investigators present the diastolic pressure of the three intervented groups
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30 days
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協力者と研究者
捜査官
- 主任研究者：Elena García-García, PDI、Universidad Miguel Hernandez de Elche
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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