Immune and Cognitive Benefits of Mango Intake in Young Adults

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06229262
• Other study ID #: 5230334
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Loma Linda University
• Contact: Sujatha Rajaram, PhD
• Phone: 909-558-4300
• Email: srajaram[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition
• Immunity

Intervention

Dietary Supplement:
• Mango group
Participants will consume 1.5 cups of mangos per day for 12 weeks.

Locations

Country	Name	City	State
United States	Loma Linda University School of Public Health	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	National Mango Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in Lymphocyte activity	The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)	baseline to 12 weeks
Primary	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
Primary	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-?, E-selectin,	baseline to 12 weeks
Primary	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
Primary	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