Sağlıklı Yaşlanmada Kızılcığın Mikrobiyom ve Beyin Üzerindeki Etkisi Çalışması (COMBAT)

Sade dilde özet

Bu çalışma, dondurularak kurutulmuş kızılcık (cranberry) tozunun sağlıklı yaşlanmada bağırsak mikrobiyomu ve beyin üzerindeki etkisini plaseboyla karşılaştırıyor. 50-80 yaş arası, herhangi bir bunama veya önemli bir nörolojik durumu olmayan sağlıklı kişiler katılabiliyor. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Tamamlandı

Sponsor

University of East Anglia

Müdahale

Freeze-Dried Cranberry Powder, Placebo

Başlangıç

02.10.2018

Tahmini bitiş

22.05.2020

Ülkeler

United Kingdom

İlgili genler

Merkezler

• Norwich, United Kingdom

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Aged between 50 and 80 years old.
* Willing and able to provide written informed consent.
* Fluent in written and spoken English.
* Normal or corrected to normal vision and hearing.
* Understands and is willing and able to comply with all study procedures.

Exclusion Criteria:

* Diagnosis of any form of dementia or significant neurological condition.
* Significant memory complaints.
* Past history or MRI evidence of brain damage, including significant trauma, stroke, learning difficulties or serious neurological disorder, including a loss of consciousness for more than 24 hours.
* Currently smoking or ceased smoking less than 6 months ago.
* Chronic fatigue syndrome, liver disease, diabetes mellitus, or gall bladder abnormalities.
* History of alcohol or drug dependency.
* Clinically diagnosed psychiatric disorder.
* Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids.
* Known allergy to the intervention supplement.
* Any significant medical condition likely to affect participation.
* Currently a participant or have been a participant in any other study involving an investigational product within the last 4 weeks.
* Uncontrolled hypertension (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg).
* Major cardiovascular event, such as myocardial infarction, within the last 12 months.
* On a stable prescription of blood pressure lowering medication or non-steroidal anti-inflammatory drugs. for fewer than 2 months.
* Prescribed anti-coagulant/blood thinning medication (eg. warfarin).
* Taking flavonoid containing supplements (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements.
* High flavonoid intake defined as \> 15 portions of flavonoid rich foods per day
* Are currently taking medication or supplements which have a significant impact on the outcome measures.

In addition, any participants with claustrophobia will not be invited to participate in the neuroimaging component of the study. Likewise for metal implants, e.g. pacemaker that precludes MRI.