Study to Evaluate the Effect of a Vegetal Oil on Cognitive Impairment
Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of a Vegetal Oil in the Disease's Natural Evolution in Patients Diagnosed With Cognitive Impairment or Mild to Moderate Alzheimer Disease.
調査の概要
状態
詳細な説明
The cognitive impairment syndrome is defined as a decrease of the intellectual performance with respect to a previous step in time. The Cognitive impairment has to be considered as a functional alteration with a continuous and physiological evolution in which happen a set of different circumstances:
- A increasing and normal reduction, that appears after the age of sixty, also known as Age-associated memory impairment (AAMI)
- A mild cognitive impairment (MCI), with a recent and mild loss of memory, but higher to that expected because of patient's age and educational level.
- A severe pathological decrease of the mental abilities, also known as, depending on its characteristics: Severe cognitive impairment (SCI), senile dementia and Alzheimer's disease (1).
In the next years it is expected that this disease will become one of the main health and aged-related problem in aged people.(2) Nowadays, there are 35,6 million people with any kind of dementia, and it is estimated that every year, 7,7 million of new patients are diagnosed. (3) The amount of people affected will probably duplicate every 20 years, if effective treatments to stop its evolution are not developed. The forecast estimate up to 81,1 million of patients in 2040, which make this disease in a XXI century real epidemic.(4)
Before reaching the level of dementia, SCI or Alzheimer's disease, the patient will suffer a progressive mild cognitive impairment. In this level, the disease can be early diagnosed and it would be worth to act on it.
Evidences of the Polyunsaturated oils use on the prevention and/or treatment of cognitive impairment.
Polyunsaturated fatty acids (PUFA) can help to improve the cognitive functions. Neuronal tissues, as the brain, retina and the neurone-covering membranes (myelin) include high levels of PUFA. (5) PUFA's act on the order transmission in the Nervous System. Population studies reported the beneficial effect of fish oil, with a high PUFA concentration, on the memory of patients suffering a mild cognitive impairment. (6) It can be also beneficial for Alzheimer's patients, as they are deficient in PUFA's. A diet rich in PUFA'S can improve the cognitive function on patients con cognitive impairment and Alzheimer's disease. (6-8) Epidemiological studies suggest that oils rich in short chain PUFA, should play a beneficial role stopping the initial progression of Alzheimer's disease.
The previous data confirm the possibility of a beneficial effect of the product to study (a mixture of vegetable oils, rich in triglyceride and lecithins) due to the common characteristic of the product with those PUFA's already marketed.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Vicente Navarro-López, MD
- メール：vnavarro@ucam.edu
研究連絡先のバックアップ
- 名前：Miguel A Carrión-Gutiérrez, PhD
- メール：miguelcarrion65@gmail.com
研究場所
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Alicante
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Elche、Alicante、スペイン、03293
- 募集
- Hospital Universitario Vinalopó
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コンタクト：
- Ana Fríes-Ramos, MD
- メール：afries@vinaloposalud.com
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Torrevieja,、Alicante、スペイン、03186
- 募集
- Hospital Universitario de Torrevieja
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コンタクト：
- Rosa Vela-Yebra, MD
- メール：rvela@torrevieja-salud.com
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コンタクト：
- María A Méndez-Miralles, MD
- メール：mamendez@torrevieja-salud.com
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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:
- informed consents signed by patients and/or caretaker
- The patient has to fulfil dementia clinical criteria.
- Age between 55 and 85 years old.
- MMSE score between 18 and 26.
- The patient can fulfil all neuropsychologic test, according to investigator.
- The patient has to be always with his/her caretaker during monitorization visits
- The caretaker has to be in regular contact with the patient, knowing his/her situation and participation in the study.
- The caretaker has to check four times per week, at least, the product intake, as well as the routine medication and his/her dietetic habits.
- Both caretaker and patient have to be able to complete the product intake during all the length of the study, according to the main investigator.
Exclusion Criteria:
- Patient and/or caretaker not being able to understand and agree in writing their participation in the study.
- Patient disability to oral intake of products.
- Known allergy to any of the product components (active and placebo)
- Evidence of suffering other neuropsychiatric disturbances apart of dementia as: Parkinson disease, psychotic disturbance, bipolar depression.
- regular intake of alcohol higher than 45 g ethanol/day, during the year before study inclusion.
- Any known concurrent malignant pathology in the moment of study inclusion, or severe metabolic, cardiovascular, renal, hepatic, or gastrointestinal disease that cannot allow the ending of the study according the investigator.
- Any analytical abnormality during the screening, apart from: Creatinine no less than 1.7 mg/dL; low levels of Vitamin B12, and TSH abnormal values.
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：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Lipidic Blend 1
Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day
|
daily intake of the content of one 45 mL bottle containing the product
|
|
アクティブコンパレータ：Lipidic Blend 2
Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day
|
daily intake of the content of one 45 mL bottle containing the product
|
|
プラセボコンパレーター：Placebo
Glass bottle with 45 ml of Olive oil. 1 bottle per day
|
daily intake of the content of one 45 mL bottle containing olive oil
|
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 |
時間枠 |
|---|---|
|
Changes in Mini-Mental State Examination (MMSE) score
時間枠：baseline, 3 month, 6 month, 9 month, 12 month
|
baseline, 3 month, 6 month, 9 month, 12 month
|
|
Changes in Global Clinical Dementia Rating (CDR) score
時間枠：baseline, 3 month, 6 month, 9 month, 12 month
|
baseline, 3 month, 6 month, 9 month, 12 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in systemic oxidative parameters in periferic blood samples (Nitric Oxyde)
時間枠：baseline, 12 month
|
baseline, 12 month
|
|
|
Changes in systemic oxidative parameters in periferic blood samples (Malondialdehyde (MDA))
時間枠：baseline, 12 month
|
baseline, 12 month
|
|
|
Changes in beta-amyloid protein concentration
時間枠：baseline, 12 month
|
Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study.
|
baseline, 12 month
|
|
Changes in TAU-Protein concentration
時間枠：baseline, 12 month
|
Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study.
|
baseline, 12 month
|
|
Changes in regular treatment for the cognitive impairment
時間枠：baseline, 3 month, 6 month, 9 month, 12 month
|
baseline, 3 month, 6 month, 9 month, 12 month
|
|
|
Changes in dietetic habits
時間枠：baseline, 3 month, 6 month, 9 month, 12 month
|
baseline, 3 month, 6 month, 9 month, 12 month
|
|
|
Changes in Barthel score
時間枠：baseline, 3 month, 6 month, 9 month, 12 month
|
baseline, 3 month, 6 month, 9 month, 12 month
|
|
|
Changes in Morisky-Green score
時間枠：baseline, 3 month, 6 month, 9 month, 12 month
|
baseline, 3 month, 6 month, 9 month, 12 month
|
|
|
changes in weight
時間枠：baseline, 3 month, 6 month, 9 month, 12 month
|
baseline, 3 month, 6 month, 9 month, 12 month
|
|
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Number of adverse events
時間枠：baseline, 3 month, 6 month, 9 month, 12 month
|
Number of adverse events related or nonrelated to the study or placebo products.
|
baseline, 3 month, 6 month, 9 month, 12 month
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター：Vicente Navarro-López, MD、Universidad Católica San Antonio de Murcia
出版物と役立つリンク
一般刊行物
- Kueider AM, Parisi JM, Gross AL, Rebok GW. Computerized cognitive training with older adults: a systematic review. PLoS One. 2012;7(7):e40588. doi: 10.1371/journal.pone.0040588. Epub 2012 Jul 11.
- Luck T, Luppa M, Briel S, Riedel-Heller SG. Incidence of mild cognitive impairment: a systematic review. Dement Geriatr Cogn Disord. 2010;29(2):164-75. doi: 10.1159/000272424. Epub 2010 Feb 11.
- Coronado M, et al. Los ácidos grasos omega-3 y omega-6: Nutrición, bioquímica y salud. REB 25(3) 2006: 72-79
- Swanson D, Block R, Mousa SA. Omega-3 fatty acids EPA and DHA: health benefits throughout life. Adv Nutr. 2012 Jan;3(1):1-7. doi: 10.3945/an.111.000893. Epub 2012 Jan 5.
- Lee LK, Shahar S, Chin AV, Yusoff NA. Docosahexaenoic acid-concentrated fish oil supplementation in subjects with mild cognitive impairment (MCI): a 12-month randomised, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2013 Feb;225(3):605-12. doi: 10.1007/s00213-012-2848-0. Epub 2012 Aug 30.
- Larrieu S, Letenneur L, Berr C, Dartigues JF, Ritchie K, Alperovitch A, Tavernier B, Barberger-Gateau P. Sociodemographic differences in dietary habits in a population-based sample of elderly subjects: the 3C study. J Nutr Health Aging. 2004;8(6):497-502.
- Gillette Guyonnet S, Abellan Van Kan G, Andrieu S, Barberger Gateau P, Berr C, Bonnefoy M, Dartigues JF, de Groot L, Ferry M, Galan P, Hercberg S, Jeandel C, Morris MC, Nourhashemi F, Payette H, Poulain JP, Portet F, Roussel AM, Ritz P, Rolland Y, Vellas B. IANA task force on nutrition and cognitive decline with aging. J Nutr Health Aging. 2007 Mar-Apr;11(2):132-52.
- Logan AC. Neurobehavioral aspects of omega-3 fatty acids: possible mechanisms and therapeutic value in major depression. Altern Med Rev. 2003 Nov;8(4):410-25.
- Bourre JM. Roles of unsaturated fatty acids (especially omega-3 fatty acids) in the brain at various ages and during ageing. J Nutr Health Aging. 2004;8(3):163-74.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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。
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