関節可動性に関する植物抽出物の組み合わせ (BSL_EP028) の評価
関節の可動性、身体能力、活力に対する植物抽出物（BSL_EP028）の組み合わせの摂取の影響を評価するためのパイロット研究
The aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The natural aging process involves several body changes that can affect to the mobility of subjects. Among them, those that affect the joints may have the greatest impact on mobility. With age, there is a progressive loss of the cartilage that covers the joints, as well as the synovial fluid, which in turn increases the stiffness of the ligaments and tendons that allow joint mobility, which implies a reduction in muscle tone and bone strength. This joint degeneration produces pain and discomfort, which leads to stiffness and restriction of movement. Therefore, and as a consequence of this loss of mobility, subjects decrease their physical performance, which can affect their mood and vitality. All of these may lead to a loss of quality of life and to an increase of the risk of future adverse health events, such as disability, institutionalization, hospitalization and the need for home medical care.
For all these reasons, and considering the increase in the ageing population worldwide, it seems relevant to develop new strategies to improve joint mobility, physical performance and vitality that are safe for the consumer, affordable and not associated with undesirable side effects. In this regard, natural plant extracts have been widely used as a traditional remedy to reduce joint pain, reduce fatigue and improve mood and physical performance.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
Madrid
-
Villaviciosa de Odón、Madrid、スペイン、28670
- Universidad Europea de Madrid
-
-
参加基準
適格基準
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:
- Healthy men and women that have joint discomfort (WOMAC score >20)
Exclusion Criteria:
- Consumption of pharmacological treatments on an ongoing basis that may affect joint mobility (chondroprotectors, corticoids and/or interarticular therapy or infiltrations).
- Having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative osteoarthritis made by a rheumatologist/traumatologist
- Consuming nutritional supplements containing antioxidant substances
- Consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or scheduled basis and will continue to do so during the study, even if they do not have pain.
- Being unable to perform the physical tests required in the study.
- Have an allergy to some component of the study product.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Combination of Plant Extracts (BSL_EP028)
Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028) |
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. |
|
プラセボコンパレーター：Placebo
Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin. |
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test
時間枠：8 weeks
|
It is a questionnaire consisting of 24 items divided into 3 subscales:
|
8 weeks
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SF-36 Vitality score
時間枠：8 weeks
|
Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality) |
8 weeks
|
|
Physical activity measurement
時間枠：8 weeks
|
Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week |
8 weeks
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluation of Knee Pain
時間枠：8 weeks
|
Knee pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
8 weeks
|
|
Evaluation of Hip Pain
時間枠：8 weeks
|
Hip pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
8 weeks
|
|
Timed Up and Go test
時間枠：8 weeks
|
This test evaluates mobility and balance by measuring the time it takes a person to get up from a chair, walk three meters, turn around, walk to the chair, and sit. |
8 weeks
|
|
30 sec Chair Stand test
時間枠：8 weeks
|
This test evaluates the strength and endurance of the lower limbs by measuring the number of times a person can get up from a chair, with arms crossed at the chest, for 30 seconds. |
8 weeks
|
|
Manual Dynamometry
時間枠：8 weeks
|
Evaluates the grip strength of both hands |
8 weeks
|
|
Evaluation of Muscular power and fatigue of the lower limbs
時間枠：8 weeks
|
We evaluate the strength-velocity profile that the person has in the lower limbs through a linear encoder. It measures the speed of execution of a squat (extension of hips and knees) with three different loads. |
8 weeks
|
|
Goniometric study
時間枠：8 weeks
|
Evaluates the angles and ranges of movement of the hip joint (flexo-extension, abduction-adduction, internal-external rotation) and the femorotibial (flexo-extension). |
8 weeks
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Helios Pareja Galeano、Universidad Europea de Madrid
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
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