NCT06229262

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

January 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
2.3 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 19, 2024

Last Update Submit

January 28, 2026

Conditions

Keywords

MangoImmunitycognition

Outcome Measures

Primary Outcomes (6)

  • 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

  • changes from baseline in global cognitive composite score

    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

  • 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

Study Arms (2)

Mango Group

ACTIVE COMPARATOR

Participants in the Mango group will consume 1.5 cups of mangos for 12 weeks

Dietary Supplement: Mango group

control group

NO INTERVENTION

The control group will receive no dietary intervention. they will follow usual diet and abstain from eating mangos

Interventions

Mango groupDIETARY_SUPPLEMENT

Participants will consume 1.5 cups of mangos per day for 12 weeks.

Mango Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female college students aged 18-30 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

Location

Study Officials

  • Sujatha Rajaram, PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sujatha Rajaram, PhD

CONTACT

Amandeep Wright, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator and outcome assessor will not be aware of which participant is in which arm
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: this will be a12 week, parallel study , free living with college going young adults aged 18-30 years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 29, 2024

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations