Gut HealthNCT07559604
The Effects of Mango on Gut Health Markers
A study testing Mango in people with Gut Health and LBP, run by Loma Linda University at 1 site in United States.
Trial summary
This is an ancillary study of NCT06159543, which was a clinical trial that examined the effect of a 12-week 1.5 cups daily mango crossover intervention on cardiometabolic outcomes in individuals with prediabetes, male and female, and 40-60 years of age. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Gut Health, LBP, Short Chain Fatty Acids
- What is being tested?
- Mango
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participated in NCT06159543
Who cannot join
- Did not participate in NCT06159543
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
Nutrition Research Center, School of Public Health, Loma Linda University
Loma Linda, California, 92350
About this study
Official title: The Effects of Fresh Mango Consumption on Gut Permeability Markers and Short Chain Fatty Acid Production in Individuals With Prediabetes
This is an ancillary study of NCT06159543, which was a clinical trial that examined the effect of a 12-week 1.5 cups daily mango crossover intervention on cardiometabolic outcomes in individuals with prediabetes, male and female, and 40-60 years of age. The goal of this ancillary study is to test the effect of the mango intervention on gut health markers in individuals with prediabetes. The main questions it aims to answer are:
- What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of gut permeability as measured by lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14)?
- What is the effect of 1.5 cups per day of fresh mango over 12 weeks on microbiome modulation as estimated by short chain fatty acids (SCFAs)?
Read more
Secondarily:
- Is LBP a mediator of the relationship between systemic inflammation [as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)] and SCFAs?
- Is LBP a mediator of the relationship between insulin resistance [as determined by HOMA-IR] and SCFAs?
- Is sCD14 a mediator of the relationship between systemic inflammation [as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)] and SCFAs?
- Is sCD14 a mediator of the relationship between insulin resistance [as determined by HOMA-IR] and SCFAs?
Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in LBP, sCD14, and SCFAs.
As noted, this is an ancillary study of NCT06159543. Fasting blood was collected at baseline, and at the end of each phase of NCT06159543. This blood will be used to analyze LBP, sCD14 and SCFAs. Fasting blood and insulin were analyzed in NCT06159543, and will used to calculate HOMA-IR in the ancillary study. C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1) will be analyzed NCT06159543.
- Conditions
- Gut Health, LBP, Short Chain Fatty Acids, sCD14
- Being tested
- Mango
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MangoBehavioural
1.5 cups/day of mango for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mango added to habitual diet | Experimental | In NCT06159543 participants were asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet. Receives: Behavioral: Mango |
| Habitual diet without mango | No intervention | In NCT06159543 participants were asked to refrain consuming mangoes for 12 weeks while continuing their habitual diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipopolysaccharide-binding protein (LBP)
Lipopolysaccharide-binding protein (LBP) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
Measured: From baseline to the end of 8 months
sCD14
sCD14 will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
Measured: From baseline to the end of 8 months
Short Chain Fatty Acids (SCFAs)
Short Chain Fatty Acids (SCFAs) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
Measured: From baseline to the end of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celine Heskey, Loma Linda University
- Investigators
- Celine Heskey, DrPH, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559604
- Sponsor's protocol ID
- 5260012
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fresh Mango Consumption on Gut Permeability Markers and Short Chain Fatty Acid Production in Individuals With Prediabetes
- ClinicalTrials.gov ID
- NCT07559604
- Acronym / sponsor ID
- 5260012
- Conditions
- Gut Health, LBP, Short Chain Fatty Acids, sCD14
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Apr 2026 (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.
This is an ancillary study of NCT06159543, which was a clinical trial that examined the effect of a 12-week 1.5 cups daily mango crossover intervention on cardiometabolic outcomes in individuals with prediabetes, male and female, and 40-60 years of age. The goal of this ancillary study is to test the effect of the mango intervention on gut health markers in individuals with prediabetes. The main questions it aims to answer are:
- What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of gut permeability as measured by lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14)?
- What is the effect of 1.5 cups per day of fresh mango over 12 weeks on microbiome modulation as estimated by short chain fatty acids (SCFAs)?
Secondarily:
- Is LBP a mediator of the relationship between systemic inflammation [as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)] and SCFAs?
- Is LBP a mediator of the relationship between insulin resistance [as determined by HOMA-IR] and SCFAs?
- Is sCD14 a mediator of the relationship between systemic inflammation [as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)] and SCFAs?
- Is sCD14 a mediator of the relationship between insulin resistance [as determined by HOMA-IR] and SCFAs?
Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in LBP, sCD14, and SCFAs.
As noted, this is an ancillary study of NCT06159543. Fasting blood was collected at baseline, and at the end of each phase of NCT06159543. This blood will be used to analyze LBP, sCD14 and SCFAs. Fasting blood and insulin were analyzed in NCT06159543, and will used to calculate HOMA-IR in the ancillary study. C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1) will be analyzed NCT06159543.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mango added to habitual diet | Experimental | Behavioral: MangoIn NCT06159543 participants were asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet. |
| Habitual diet without mango | No intervention | –In NCT06159543 participants were asked to refrain consuming mangoes for 12 weeks while continuing their habitual diet. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participated in NCT06159543
Key exclusion criteria (1 listed)
- Did not participate in NCT06159543
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 |
|---|---|---|
| Mango1.5 cups/day of mango for 12 weeks | Behavioural | Mango added to habitual diet |
Primary outcome
Lipopolysaccharide-binding protein (LBP)
Time frame: From baseline to the end of 8 months
Lipopolysaccharide-binding protein (LBP) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
sCD14
Time frame: From baseline to the end of 8 months
sCD14 will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
Short Chain Fatty Acids (SCFAs)
Time frame: From baseline to the end of 8 months
Short Chain Fatty Acids (SCFAs) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
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 16 Oct 2026.
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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.
Celine Heskey, DrPH principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mango in people with Gut Health and LBP, run by Loma Linda 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 16 Oct 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?
Contact Amandeep Wright, MPH ((909) 558-4300 ext. 47169, amawright@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipopolysaccharide-binding protein (LBP) (time frame: From baseline to the end of 8 months). The study lists 3 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 16 Oct 2026.