The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte Membranes
The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte and Neuromuscular System in Athletes
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Katowice、ポーランド、40-065
- Academy of Physical Education in Katowice
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
**Inclusion Criteria:**
- Male participants aged 20-40 years.
- Apparently healthy individuals, as determined by medical history and self-reported health status.
- Physically active, engaging in regular physical activity at least 3 times per week for the previous 6 months.
- Following a mixed diet.
- Willingness to maintain habitual dietary and physical activity patterns throughout the study.
- Willingness to refrain from consuming dietary supplements other than those provided as part of the study.
**Exclusion Criteria:**
- Current use of dietary supplements within 4 weeks prior to enrollment.
- Following a low-carbohydrate, ketogenic, high-carbohydrate, vegetarian, or vegan diet.
- Presence of gastrointestinal disorders affecting nutrient absorption, including irritable bowel syndrome, inflammatory bowel disease, celiac disease, or other clinically significant gastrointestinal conditions.
- History of cardiovascular, metabolic, endocrine, hepatic, renal, neurological, or autoimmune diseases.
- Current use of medications known to affect lipid metabolism, inflammation, antioxidant status, or cognitive function.
- Known allergy or intolerance to study supplements or their ingredients.
- Participation in another clinical trial within the previous 3 months.
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:診断
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:AL (Alpha-linolenic acid) supplementation
Participants were randomly assigned to the ALA supplementation group.
After 4 weeks of the supplementation, there was a 12-week wash-out period, after which the participants crossed over to the EPA /DHA group.
|
The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks.
Daily dose will contain 3500mg ALA.
|
|
実験的:EPA (eicosapentaenoic acid)/DHA (docosahexaenoic acid) supplementation
Participants were randomly assigned to the EPA/DHA supplementation group.
After 4 weeks of the supplementation, there was a 12-week wash-out period, after which the participants crossed over to the ALA group.
|
The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks.
Each capsule will contain 330mg EPA and 220mgDHA.
他の名前:
|
|
プラセボコンパレーター:Placebo supplementation
Participants were randomly assigned to the Placebo group.
After 4 weeks of the supplementation, there was a 12-week wash-out period, after which they repeated the placebo supplementation.
|
The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks.
One capsule will contain 550 mg of olive oil.
The placebo will be matched to the supplement in appearance.
|
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 |
|---|---|---|
|
Omega 3 index
時間枠:4-weeks
|
The Omega-3 Index (%) determines the content of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) relative to total fatty acids in erythrocyte membranes. It is expressed as a percentage and reflects long-term fatty acid intake. Unit of Measure: % |
4-weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tensiomyography (TMG) Parameters
時間枠:4-weeks
|
2a.
Maximal Radial Displacement (Dm) Unit of Measure: mm 2b.
Contraction Time (Tc) Unit of Measure: ms 2c.
Delay Time (Td) Unit of Measure: ms 2d.
Sustain Time (Ts) Unit of Measure: ms 2e.
Half-Relaxation Time (Tr) Unit of Measure: ms Description: Muscle contractile properties assessed using tensiomyography (TMG-BMC system).
|
4-weeks
|
|
Corsi Block-Tapping Test - Unweighted Block Span
時間枠:4-weeks
|
Description: Maximum correctly reproduced sequence length in Corsi Block-Tapping Test. Unit of Measure: blocks |
4-weeks
|
|
Corsi Block-Tapping Test - Block Time
時間枠:4 weeks
|
Description: Reaction time performance in visuospatial working memory assessed using Corsi Block-Tapping Test. Unit of Measure: ms |
4 weeks
|
|
Corsi Block-Tapping Test - Reverse Span Score
時間枠:4 weeks
|
Description: Working memory performance assessed using reverse span condition of Corsi Block-Tapping Test. Unit of Measure: score |
4 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Antioxidant Status (TAS)
時間枠:4 weeks
|
Description: Plasma total antioxidant status measured using Randox TAS kit. Unit of Measure: mmol/L |
4 weeks
|
|
Malondialdehyde (MDA) Concentration
時間枠:4 weeks
|
Description: Plasma malondialdehyde concentration measured using thiobarbituric acid reactive substances method. Unit of Measure: nmol/mL |
4 weeks
|
|
Superoxide Dismutase (SOD) Activity
時間枠:4 weeks
|
Description: Activity of superoxide dismutase in red blood cell lysates measured using Randox kits. Unit of Measure: U/g Hb |
4 weeks
|
|
Glutathione Peroxidase (GPx) Activity
時間枠:4 weeks
|
Description: Activity of glutathione peroxidase in red blood cell lysates measured using Randox kits. Unit of Measure: U/g Hb |
4 weeks
|
|
Body Mass
時間枠:4 weeks
|
Description: Body mass measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: kg |
4 weeks
|
|
Body Fat Percentage
時間枠:4 weeks
|
Description: Body fat percentage measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: % |
4 weeks
|
協力者と研究者
捜査官
- スタディディレクター:Małgorzata Magdalena Michalczyk, Phd、Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
その他の研究ID番号
- 4-II/2024
- 2024/53/B/NZ7/02257 (その他の助成金/資金番号:Narodowe Centrum Nauki)
- RID/SP/0053/2024/01 (その他の識別子:The Regional Initiative of Excellence programme)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。