Gut MicrobiomeNCT06800833
Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health
A study testing Low fat cookies and Mango in people with Gut Microbiome, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome
- What is being tested?
- Low fat cookies and Mango
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy subjects
- BMI 20-40 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92182
Mee Young Hong, 619-594-6825, mhong2@sdsu.edu
About this study
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.
- Conditions
- Gut Microbiome
- Being tested
- Low fat cookies, Mango
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat cookiesOther
To determine the effects of low fat cookie consumption on physiological indicators of sexual, mental, skin, and gut health
MangoOther
To determine the effects of mango consumption on physiological indicators of sexual, mental, skin, and gut health
| Study group | Role | What they receive |
|---|---|---|
| Low fat cookies | Active comparator | Subjects consume 100 kcal of low-fat cookies daily for 4 weeks. Receives: Other: Low fat cookies |
| Mango | Experimental | Subjects consume 100 kcal of mango daily for 4 weeks. Receives: Other: Mango |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start23 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800833
- Sponsor's protocol ID
- IRB-25-0010
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health
- ClinicalTrials.gov ID
- NCT06800833
- Acronym / sponsor ID
- IRB-25-0010
- Conditions
- Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low fat cookies | Active comparator | Other: Low fat cookiesSubjects consume 100 kcal of low-fat cookies daily for 4 weeks. |
| Mango | Experimental | Other: MangoSubjects consume 100 kcal of mango daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Generally healthy subjects
- BMI 20-40 kg/m2
Key exclusion criteria (6 listed)
- Smoker
- Pregnant woman
- Required antibiotics use
- Required dietary supplement use
- Required medication of metabolic disorders, mental health and sexual health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fat cookiesTo determine the effects of low fat cookie consumption on physiological indicators of sexual, mental, skin, and gut health | Other | Low fat cookies |
| MangoTo determine the effects of mango consumption on physiological indicators of sexual, mental, skin, and gut health | Other | Mango |
Primary outcome
Change of sexual health questionnaire scores
Time frame: Baseline and week 4
Change of sexual health questionnaire scores will be determined to examine effects of mango consumption vs low-fat cookies.
Change of depression questionnaire scores
Time frame: Baseline and week 4
Change of depression questionnaire scores will be determined to examine effects of mango consumption vs low-fat cookies.
Change of skin hydration scores
Time frame: Baseline, 1 min post application and week 4consumption
Change of skin hydration scores will be determined to examine effects of mango consumption vs low-fat cookies
Change of microbiome diversity
Time frame: Baseline and week 4
Change of microbiome diversity will be determined to examine effects of mango consumption vs low-fat cookies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat cookies and Mango in people with Gut Microbiome, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of sexual health questionnaire scores (time frame: Baseline and week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.