Clinical TrialID 745

Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption

NCT04726293

Overweight or Obesity|Healthy

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Record Fields

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Clinical Trial Id
745
Evidence Id
745
Core Evidence Id
745
Source Clinical Trial Id
730
Herb2 Clinical Trial Id
HBCT000730
Nct Id
NCT04726293
Title
Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption
Status
Active_Not_Recruiting
Phase
Study Result
No
Study Condition
Overweight or Obesity|Healthy
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Intervention
DIETARY_SUPPLEMENT: Mango|DIETARY_SUPPLEMENT: Control
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Single
Intervention Purpose
Other
Gender
All
Age
Adult
Enrollment
60
Outcome Measure
Characterize indices of systemic inflammation (IL-6) after 4 week intake of mango beverage compared to a control beverage, Assessments to address this aim will include analysis of systemic markers of inflammation (IL-6) in plasma, Baseline to 4 weeks|Characterize indices of systemic inflammation mechanism of action after 4 week intake of mango beverage compared to a control beverage, Assessments to address this aim via Toll like receptor, Nuclear factor erythroid 2-related factor 2, and nuclear factor kappa-light-chain-enhancer of activated B cells (TLR/Nrf2/NF-κB) activation in Monocytes isolated from peripheral blood., Baseline to 4 weeks|Characterize indices of systemic inflammation mechanism of action (Toll like receptor) after 4 week intake of mango beverage compared to a control beverage, Assessments to address this aim via Toll-like receptor, activation in Monocytes isolated from peripheral blood., Baseline to 4 weeks|Characterize indices of systemic inflammation mechanism of action (nuclear factor kappa-light-chain-enhancer of activated B cells ) after 4 week intake of mango beverage compared to a control beverage, Assessments to address this aim via nuclear factor kappa-light-chain-enhancer of activated B cells activation in Monocytes isolated from peripheral blood., Baseline to 4 weeks|Characterize indices of systemic inflammation mechanism of action (Nuclear factor erythroid 2-related factor 2) after 4 week intake of mango beverage compared to a control beverage, Assessments to address this aim via (Nuclear factor erythroid 2-related factor 2 activation in Monocytes isolated from peripheral blood., Baseline to 4 weeks|Characterize the gut microbiota in response to regular mango intake in OW/OB participants with chronic low grade inflammation., Fecal samples will be collected with standard collection kits and stored at -80°C until analysis. Metagenomic and transcriptomic analyses will be performed, Baseline to 4 weeks|Characterize indices of systemic inflammation (hs-CRP) after 4 week intake of mango beverage compared to a control beverage, Assessments to address this aim will include analysis of systemic markers of inflammation (hs-CRP) in plasma, Baseline to 4 weeks|Characterize indices of systemic inflammation (TNF-α) after 4 week intake of mango beverage compared to a control beverage, Assessments to address this aim will include analysis of systemic markers of inflammation (TNF-α) in plasma, Baseline to 4 weeks|Characterize indices of systemic inflammation (MCP-1) after 4 week intake of mango beverage compared to a control beverage, Assessments to address this aim will include analysis of systemic markers of inflammation (MCP-1) in plasma, Baseline to 4 weeks
Sponsor Collaborator
Clinical Nutrition Research Center, Illinois Institute of Technology|Food and Drug Administration (FDA)
Funded By
INDUSTRY
Location
Clinical Nutrition Research Center, Chicago, Illinois, 60616, United States
Other Id
IRB-2020-57
Start Date
2021-02-22
Primary Completion Date
2023-03-31
Completion Date
2025-01-28
First Posted
2021-01-27
Results First Posted
Last Update Posted
2024-08-09
Study Document
Study Url
https://clinicaltrials.gov/study/NCT04726293
Title Cn
Title En
Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption
Bilingual Status
semi_complete