Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders
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|ClinicalTrials.gov Identifier: NCT03723694|
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : July 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Memory Loss Inflammation||Dietary Supplement: 650 mg of Cocoapro flavanols Dietary Supplement: 0 mg of Cocoapro flavanols||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||November 25, 2023|
|Estimated Study Completion Date :||June 30, 2024|
Active Comparator: 650 mg of Cocoapro flavanols
Daily, each subject will consume either two cocoa flavanol-containing capsules twice a day with a meal.
Dietary Supplement: 650 mg of Cocoapro flavanols
12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(650mg) twice a day with meals.
Placebo Comparator: 0mg Cocoapro flavanols
Daily, each subject will consume either ttwo placebo-containing capsules twice a day with a meal.
Dietary Supplement: 0 mg of Cocoapro flavanols
12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(0mg) twice a day with meals.
- HMGB1 [ Time Frame: 12 weeks ]circulating levels of the inflammatory marker HMGB1
- NFkB [ Time Frame: 12 weeks ]TLR4-dependent NFkB
- TNFa [ Time Frame: 12 weeks ]TLR4-dependent TNFa
- ModBent [ Time Frame: 12 weeks ]modified Benton Recognition Task
- ModRey [ Time Frame: 12 weeks ]Modified Rey Auditory Verbal Learning Test
- multiple cognitive domains [ Time Frame: 12 weeks ]NIH Toolbox Cognition Battery, which includes adaptive computerized tests of executive function, attention, episodic memory, language, processing speed, and working memory
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723694