Immune and Cognitive Benefits of Mango Intake in Young Adults

Immune and Cognitive Benefits of Mango Intake in Young Adults: A Randomized Trial

The main objectives of our proposed study are to determine the effects of mango consumption on immune and cognitive functions in free-living college going young adults aged 18-30 years

Study Overview

• Status: Not yet recruiting
• Conditions: Immunity; Cognition
• Intervention / Treatment: Dietary supplement: Mango group

Detailed Description

The main objectives of our proposed study are to determine the effects of mango consumption on immune and cognitive functions in free-living college going young adults aged 18-30. To accomplish these objectives, a randomized controlled, parallel design study is proposed with two groups consuming their habitual diet, but with one (Mango group) receiving 1.5 servings of mango/day and the other (Control group) abstaining from eating any mango for the duration of the study.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• 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

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mango Group; Participants in the Mango group will consume 1.5 cups of mangos for 12 weeks	Dietary supplement: Mango group; 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

Outcome Measure	Measure Description	Time Frame
changes from baseline in global cognitive composite score	The composite score will be calculated using the scores from the tests listed below. We will calculate 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
Change in serum brain-derived neurotrophic factor (pg/mL)	changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA	baseline to 12 weeks
Changes in lymphocyte populations	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	The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)	baseline to 12 weeks
Changes in cytokine production	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	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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: National Mango Board
• Investigators: Principal Investigator: Sujatha Rajaram, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cognition; Immunity; Mango
• Other Study ID Numbers: 5230334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No