Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513052
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Flavanol-rich Cocoa on Digestive and Cerebrovascular Health in the Colombian Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Consuming Flavanol-rich Cocoa on Biomarkers Associated with Digestive and Cerebrovascular Health in the Colombian Adult Population
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effects of consuming flavanol-rich cocoa on biomarkers associated with digestive and cerebrovascular health in a group of adults
Detailed Description:
The study seeks 40 adults aged 20-50 with normal or slightly overweight by BMI who regularly consume cocoachocolate After recruitment participants will receive a detailed explanation of the objectives and conditions of the study and will sign the informed consent and will be randomly assigned to randomly divided into two groups Control Group that consumes a daily beverage with low-flavanol cocoa or the intervention group that consumes a daily beverage with high-flavanol cocoa Participants in each intervention arm will be matched by BMI category normal weight or overweight sex female or male and age plus or minus 5 years Both groups will consume a single daily serving 8 grams of their assigned cocoa packaged individually dissolved in low-fat and lactose-free milk 200 ml before or with their breakfast At baseline time 0 and at the end of the intervention 12 weeks each participant will be assessed for biological indicators gastrointestinal health the composition of the gut microbiota and cerebrovascular health markers associated with neuroinflammation oxidative stress and barrier function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None