Immune and Cognitive Benefits of Mango Intake in Young Adults
Immune and Cognitive Benefits of Mango Intake in Young Adults: A Randomized Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Amandeep Wright, MPH
- Phone Number: 47169 909-558-4300
- Email: amawright@llu.edu
Study Contact Backup
- Name: Sujatha Rajaram, PhD
- Phone Number: 47228 909-558-4300
- Email: srajaram@llu.edu
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda University School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female college students aged 18-30 years
Exclusion Criteria:
- known intolerance or allergy to mangos
- regular intake of mangos and/or fruits of a similar nutritional content such as peach, nectarine, papaya, apricot and cantaloupe
- using cognition and/or immune-boosting supplements or vitamins
- recent exposure to antibiotics and corticoids
- uncontrolled chronic diseases and mental illnesses, clinical depression, and immunocompromised state
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Mango Group
Participants in the Mango group will consume 1.5 cups of mangos for 12 weeks
|
Participants will consume 1.5 cups of mangos per day for 12 weeks.
|
|
No Intervention: control group
The control group will receive no dietary intervention.
they will follow usual diet and abstain from eating mangos
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in serum brain-derived neurotrophic factor (pg/mL)
Time Frame: baseline to 12 weeks
|
changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA
|
baseline to 12 weeks
|
|
Changes in lymphocyte populations
Time Frame: baseline to 12 weeks
|
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naive and memory cells and B cells
|
baseline to 12 weeks
|
|
Changes in Lymphocyte activity
Time Frame: baseline to 12 weeks
|
The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
|
baseline to 12 weeks
|
|
Changes in cytokine production
Time Frame: baseline to 12 weeks
|
The cytokines produced due to lymphocyte activity will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
|
baseline to 12 weeks
|
|
Changes in serum inflammatory cytokine concentration
Time Frame: baseline to 12 weeks
|
changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme linked immunoassay (ELISA) will include hs-CRP, interleukin (IL)-1B, IL-6, TNF a, IL-10, IL-2, IFN-γ, E-selectin,
|
baseline to 12 weeks
|
|
changes from baseline in global cognitive composite score
Time Frame: baseline to 12 weeks
|
The composite score will be calculated using the scores from the tests listed below.
Scores will be calculated with the standardized scores of each test as the score of each participant minus the group mean and divide by its standard deviation.
The composite score is the mean of the standardized scores.
the 5 tests are: Rey Auditory Verbal Learning Test (RAVLT), Brief Visuospatial Memory Test, Digit Span, FAS Word Fluency, Symbol Digit Modalities Test
|
baseline to 12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Sujatha Rajaram, PhD, Loma Linda University
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 5230334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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