NCT06800833

Brief Summary

The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress44%
Jan 2025Dec 2027

Study Start

First participant enrolled

January 23, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

January 24, 2025

Last Update Submit

January 28, 2026

Conditions

Gut Microbiome

Outcome Measures

Primary Outcomes (4)

  • Change of sexual health questionnaire scores

    Change of sexual health questionnaire scores will be determined to examine effects of mango consumption vs low-fat cookies.

    Baseline and week 4

  • Change of depression questionnaire scores

    Change of depression questionnaire scores will be determined to examine effects of mango consumption vs low-fat cookies.

    Baseline and week 4

  • Change of skin hydration scores

    Change of skin hydration scores will be determined to examine effects of mango consumption vs low-fat cookies

    Baseline, 1 min post application and week 4consumption

  • Change of microbiome diversity

    Change of microbiome diversity will be determined to examine effects of mango consumption vs low-fat cookies.

    Baseline and week 4

Study Arms (2)

Low fat cookies

ACTIVE COMPARATOR

Subjects consume 100 kcal of low-fat cookies daily for 4 weeks.

Other: Low fat cookies

Mango

EXPERIMENTAL

Subjects consume 100 kcal of mango daily for 4 weeks.

Other: Mango

Interventions

Low fat cookiesOTHER

To determine the effects of low fat cookie consumption on physiological indicators of sexual, mental, skin, and gut health

Low fat cookies
MangoOTHER

To determine the effects of mango consumption on physiological indicators of sexual, mental, skin, and gut health

Mango

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy subjects
  • BMI 20-40 kg/m2

You may not qualify if:

  • Smoker
  • Pregnant woman
  • Required antibiotics use
  • Required dietary supplement use
  • Required medication of metabolic disorders, mental health and sexual health
  • Allergy to mango or wheat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

RECRUITING

MeSH Terms

Interventions

Mangifera indica extract

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

January 23, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

US(1)