NCT06323070

Brief Summary

The objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Mar 2024

Longer than P75 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 Progress46%
Mar 2024Dec 2028

Study Start

First participant enrolled

March 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

March 14, 2024

Last Update Submit

January 16, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change of sexual health questionnaire scores

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

    Baseline, 1 min post application and week 4 consumption

  • Change of microbiome diversity

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

    Baseline and week 4

Secondary Outcomes (1)

  • Change of depression questionnaire scores

    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

Watermelon

EXPERIMENTAL

Subjects consume 100 kcal of watermelon daily for 4 weeks.

Other: Watermelon

Interventions

To determine the effects of watermelon consumption on physiological indicators of wellness regarding sexual, skin, and gut health

Watermelon

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

Low-fat cookies

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 watermelon or wheat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Exercise and Nutritional Sciences

San Diego, California, 92182, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mee Young Hong, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mee Young Hong, PhD

CONTACT

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

March 14, 2024

First Posted

March 21, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations