Healthy ParticipantsNCT07650058
Postprandial Effects of Fresh Mango as a Table Sugar Replacement in High-Sugar Breakfasts.
A study testing High-Glycemic Breakfast Containing Cereal and Fresh Mango and High-Glycemic Breakfast Containing Cereal and Table Sugar in people with Healthy Participants, run by Ball State University at 1 site in United States.
Trial summary
Systemic inflammation and intestinal hyperpermeability (disruption of the gut barrier which allows nutrient molecules and bacteria to enter the bloodstream) are triggered by consumption of high-sugar meals and are linked to future development of cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- High-Glycemic Breakfast Containing Cereal and Fresh Mango and High-Glycemic Breakfast Containing Cereal and Table Sugar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to Jan 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 45 years.
- Body mass index between 18.5-35.0 kg/m2
- Not pregnant or expecting to become pregnant (females only)
- Not postmenopausal (females only).
- No known chronic medical conditions (e.g., type 2 diabetes, cardiovascular disease, inflammatory diseases, etc.)
- No history of using tobacco/illicit drugs
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- No history of using glucose-lowering medications/supplements.
- No history of using prescribed anti-inflammatory medications
- Does not use over-the-counter anti-inflammatory medications ≥2x/week
- Does not have a pacemaker.
- No relevant food allergies/intolerances
- Able to lay supine for at least ten minutes.
Who cannot join
- Not between the ages of 18-45
- Body mass index < 18.5 kg/m2 or >35.0 kg/m2
- Pregnant (females only)
- Postmenopausal status (females only).
- Been diagnosed with a chronic medical conditions (e.g., type 2 diabetes, cardiovascular disease, inflammatory diseases, etc.)
- Uses tobacco products or any illicit drugs.
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- Uses glucose-lowering drugs/supplements.
- Regularly takes anti-inflammatory drugs (more than 2x week).
- Have a pacemaker.
- Allergic to mango, wheat, gluten, and/or milk.
- Unable to lay in supine position in the dark for at least ten minutes.
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
Health Professions Building, Ball State University
Muncie, Indiana, 47306
Bryant Keirns, PhD, 765-285-8356, bryant.keirns@bsu.edu
About this study
Official title: Effects of Fresh Mango as a Table Sugar Replacement on Postprandial Intestinal Permeability and Inflammation Following a High-Sugar Breakfast.
Systemic inflammation and intestinal hyperpermeability (disruption of the gut barrier which allows nutrient molecules and bacteria to enter the bloodstream) are triggered by consumption of high-sugar meals and are linked to future development of cardiovascular disease (CVD). Previous research indicates that fresh mangos have properties that have positive effects on the intestinal barrier and local gut inflammation. The investigators want to understand if replacing table sugar (sucrose) with sugar from fresh mango (which also contains fiber and plant bioactives) will lead to decreased inflammatory and permeability biomarkers after eating a high-sugar breakfast. The investigators will compare the postprandial (post meal) levels of inflammatory (IL-6) and permeability (LPS, lipid binding protein (LBP), and soluble CD14) biomarkers in blood from participants who have consumed a meal sweetened with either sucrose or fresh mango.
Read the detailed description
The investigators will use banked serum samples from an ongoing randomized crossover study to determine the effects of fresh mango as a substitute for added sugar on postprandial glucose and insulin in the context of high glycemic and low glycemic breakfasts. The investigators will use samples banked from the high glycemic meals and compare indicators of intestinal permeability and inflammation following corn flakes + fresh mango and corn flakes + sucrose. the samples come from recruited individuals with a BMI in the 18.5-35.0 kg/m2 range from the Ball State University campus and surrounding communities. Each participant (N=35) will complete two meal trials in random order. An indwelling intravenous catheter (IV) is placed in a forearm vein and a baseline blood sample is collected. Next, participants will consume one of the two test meals: (1) corn flakes with 2% milk + fresh mango and (2) corn flakes with 2% milk + sucrose. Corn flakes based meals reflect a commonly consumed breakfast food with high glycemic index. In each meal, total sugar (grams) will be identical, meals are nearly isocaloric (+/- ≤ 4 kcal) and macronutrients are matched.
After each meal, additional whole blood samples will be collected at 30-, 60-, 120-, and 180 minutes after participants take their first bite of food. Blood is collected into serum separator tubes, allowed to clot, centrifuged, and stored at -80 degrees C until study completion. Serum LPS, LBP, and sCD14 will be assayed in duplicate at all timepoints as indicators of intestinal permeability. Direct LPS measurement will be carried out using a cutting-edge assay (Pyrogene rFC; Lonza) that detects LPS in a single enzymatic step. LPS assays will be conducted with LPS-free consumables in sterile biosafety cabinet. LBP and sCD14 will be measured with commercially available ELISAs. Serum IL-6 will be assayed in duplicate at all time points as a measure of inflammation. IL-6 analyses will be measured externally at the Indiana University School of Medicine Translational Core on a high-sensitivity single-plex assay.
- Conditions
- Healthy Participants
- Being tested
- High-Glycemic Breakfast Containing Cereal and Fresh Mango, High-Glycemic Breakfast Containing Cereal and Table Sugar
- Keywords
- fresh mango, inflammation, intestinal permeability
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Glycemic Breakfast Containing Cereal and Fresh MangoOther
High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 262 grams of fresh mango.
High-Glycemic Breakfast Containing Cereal and Table SugarOther
High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 36 grams of table sugar.
| Study group | Role | What they receive |
|---|---|---|
| Cereal Consumption with Fresh Mango | Experimental | During the Cereal and Fresh Mango arm, participants will consume a bowl of corn flakes with 2% milk sweetened with fresh mango. Receives: Other: High-Glycemic Breakfast Containing Cereal and Fresh Mango |
| Cereal Consumption with Table Sugar | Experimental | During the Cereal and Table Sugar arm, participants will consume a bowl of corn flakes with 2% milk sweetened with table sugar. Receives: Other: High-Glycemic Breakfast Containing Cereal and Table Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPS
The investigators will measure LPS at baseline and 30-, 60-, 120-, and 180- minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1 year.
LPS Binding Protein
The investigators will measure LPS binding protein at baseline and 30-, 60-, 120-, and 180-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1 year.
IL-6
The investigators will measure IL-6 at baseline and 30-, 60-, 120-, and 180-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1 year.
Secondary outcomes (3)
sCD14
The investigators will measure soluble CD14 at baseline and 30-, 60-, 120-, and 180-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1 year.
Acceptability
The investigators will measure acceptability of each meal with a survey at each study visit once post-meal.
Measured: Through study completion, up to 1 year.
Satiety
The investigators will measure satiety through a survey at baseline and at 30-, 60-, 90-, 120-, 150-, and 180-minutes after the meal.
Measured: Through study completion, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Mango Board
- Responsible party
- Sponsor
- Investigators
- Bryant Keirns, PhD, Principal investigator, Ball State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650058
- Sponsor's protocol ID
- IRB-FY2025-25-1
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fresh Mango as a Table Sugar Replacement on Postprandial Intestinal Permeability and Inflammation Following a High-Sugar Breakfast.
- ClinicalTrials.gov ID
- NCT07650058
- Acronym / sponsor ID
- IRB-FY2025-25-1
- Conditions
- Healthy Participants
- Keywords
- fresh mango, inflammation, intestinal permeability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Collaborators
- National Mango Board
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Jun 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.
Systemic inflammation and intestinal hyperpermeability (disruption of the gut barrier which allows nutrient molecules and bacteria to enter the bloodstream) are triggered by consumption of high-sugar meals and are linked to future development of cardiovascular disease (CVD). Previous research indicates that fresh mangos have properties that have positive effects on the intestinal barrier and local gut inflammation. The investigators want to understand if replacing table sugar (sucrose) with sugar from fresh mango (which also contains fiber and plant bioactives) will lead to decreased inflammatory and permeability biomarkers after eating a high-sugar breakfast. The investigators will compare the postprandial (post meal) levels of inflammatory (IL-6) and permeability (LPS, lipid binding protein (LBP), and soluble CD14) biomarkers in blood from participants who have consumed a meal sweetened with either sucrose or fresh mango.
Detailed description
The investigators will use banked serum samples from an ongoing randomized crossover study to determine the effects of fresh mango as a substitute for added sugar on postprandial glucose and insulin in the context of high glycemic and low glycemic breakfasts. The investigators will use samples banked from the high glycemic meals and compare indicators of intestinal permeability and inflammation following corn flakes + fresh mango and corn flakes + sucrose. the samples come from recruited individuals with a BMI in the 18.5-35.0 kg/m2 range from the Ball State University campus and surrounding communities. Each participant (N=35) will complete two meal trials in random order. An indwelling intravenous catheter (IV) is placed in a forearm vein and a baseline blood sample is collected. Next, participants will consume one of the two test meals: (1) corn flakes with 2% milk + fresh mango and (2) corn flakes with 2% milk + sucrose. Corn flakes based meals reflect a commonly consumed breakfast food with high glycemic index. In each meal, total sugar (grams) will be identical, meals are nearly isocaloric (+/- ≤ 4 kcal) and macronutrients are matched.
After each meal, additional whole blood samples will be collected at 30-, 60-, 120-, and 180 minutes after participants take their first bite of food. Blood is collected into serum separator tubes, allowed to clot, centrifuged, and stored at -80 degrees C until study completion. Serum LPS, LBP, and sCD14 will be assayed in duplicate at all timepoints as indicators of intestinal permeability. Direct LPS measurement will be carried out using a cutting-edge assay (Pyrogene rFC; Lonza) that detects LPS in a single enzymatic step. LPS assays will be conducted with LPS-free consumables in sterile biosafety cabinet. LBP and sCD14 will be measured with commercially available ELISAs. Serum IL-6 will be assayed in duplicate at all time points as a measure of inflammation. IL-6 analyses will be measured externally at the Indiana University School of Medicine Translational Core on a high-sensitivity single-plex assay.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cereal Consumption with Fresh Mango | Experimental | Other: High-Glycemic Breakfast Containing Cereal and Fresh MangoDuring the Cereal and Fresh Mango arm, participants will consume a bowl of corn flakes with 2% milk sweetened with fresh mango. |
| Cereal Consumption with Table Sugar | Experimental | Other: High-Glycemic Breakfast Containing Cereal and Table SugarDuring the Cereal and Table Sugar arm, participants will consume a bowl of corn flakes with 2% milk sweetened with table sugar. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 18 - 45 years.
- Body mass index between 18.5-35.0 kg/m2
- Not pregnant or expecting to become pregnant (females only)
- Not postmenopausal (females only).
- No known chronic medical conditions (e.g., type 2 diabetes, cardiovascular disease, inflammatory diseases, etc.)
Key exclusion criteria (11 listed)
- Not between the ages of 18-45
- Body mass index < 18.5 kg/m2 or >35.0 kg/m2
- Pregnant (females only)
- Postmenopausal status (females only).
- Been diagnosed with a chronic medical conditions (e.g., type 2 diabetes, cardiovascular disease, inflammatory diseases, etc.)
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 |
|---|---|---|
| High-Glycemic Breakfast Containing Cereal and Fresh MangoHigh-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 262 grams of fresh mango. | Other | Cereal Consumption with Fresh Mango |
| High-Glycemic Breakfast Containing Cereal and Table SugarHigh-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 36 grams of table sugar. | Other | Cereal Consumption with Table Sugar |
Primary outcome
LPS
Time frame: Through study completion, up to 1 year.
The investigators will measure LPS at baseline and 30-, 60-, 120-, and 180- minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
LPS Binding Protein
Time frame: Through study completion, up to 1 year.
The investigators will measure LPS binding protein at baseline and 30-, 60-, 120-, and 180-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
IL-6
Time frame: Through study completion, up to 1 year.
The investigators will measure IL-6 at baseline and 30-, 60-, 120-, and 180-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
3 secondary outcomes
sCD14
Time frame: Through study completion, up to 1 year.
Acceptability
Time frame: Through study completion, up to 1 year.
Satiety
Time frame: Through study completion, up to 1 year.
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 Jun 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.
Bryant Keirns, PhD principal investigator
Ball State 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 High-Glycemic Breakfast Containing Cereal and Fresh Mango and High-Glycemic Breakfast Containing Cereal and Table Sugar in people with Healthy Participants, run by Ball 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 12 inclusion and 11 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 16 Jun 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 Bryant Keirns, PhD (765-285-8356, bryant.keirns@bsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LPS (time frame: Through study completion, up to 1 year.). 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 Jun 2026.