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Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome
Bu çalışma, metabolik sendromu (metabolic syndrome) olan bireylerde zerdeçal (turmeric) içeren MERIVA tabletlerinin bilişsel performans üzerindeki etkisini plaseboya (etkisiz tablet) karşı değerlendirmiştir. Çalışmaya, standart ölçütlere göre metabolik sendrom tanısı almış, 60 yaş ve üzeri kişiler katılabilmiştir. Faz uygulanmayan bu çalışma yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria:
* Male or female subjects.
* Subjects aged ≥ 60 years.
* Subjects with Metabolic Syndrome diagnosed according to standard criteria:
1. Presence of abdominal obesity (waist circumference\> 94 cm for males and\> 80 cm for females).
In addition, at least two of the following alterations:
2. Fasting blood glucose ≥ 100 mg / dl.
3. Triglycerides ≥ 150 mg / dl.
4. HDL cholesterol \<40 mg / dl for males, \<50 mg / dl for females.
5. Arterial hypertension (≥ 135/85 mmHg).
* Subjects who understand the nature of the study and provide their informed consent to participate.
* Subjects willing and able to participate in the visits and in the procedures foreseen by the study protocol.
Exclusion Criteria:
* Subjects with dementia with MMSE \<24 test and on therapy with cholinesterase inhibitors or memantine\*.
* Subjects with serious concomitant internal medical conditions or with neurological pathologies capable of causing cognitive dysfunction.
* Subjects with hepato-biliary disorders, including bile duct obstruction, cholangitis, gallstones.
* Subjects addicted to alcohol or drugs, or treated with psychotropic drugs at the time of enrollment.
* Subjects with known or suspected allergy or hypersensitivity to turmeric or other components of the experimental / placebo product.
* Subjects with Mild Cognitive Impairment (MCI) and in experimental therapy with Alzheimer's disease drugs.
* Subjects who are participating or have participated in other clinical studies within 30 days before enrollment.
* Subjects unable to sign the Informed Consent to Participation.
* In case of conversion to dementia the Subjects will be kept in the study, will be subjected to the most appropriate therapies provided for the dementia pathology but will not enter the subsequent statistical evaluations.