Healthy ParticipantsNCT07045051
Glycemic/Insulinemic Effects of Fresh Mango as a Sugar Substitute in Realistic Breakfasts.
A study testing Low-Glycemic Breakfast Containing Oats and Mango, High-Glycemic Breakfast Containing Cereal and Mango and Low-Glycemic Breakfast Containing Oats and Table Sugar in people with Healthy Participants, run by Ball State University at 1 site in United States.
Trial summary
Large blood sugar and insulin increases after meals high in table sugar are related to risk for diabetes and heart disease. Additionally, large increases in blood sugar may also negatively impact vascular health. 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?
- Low-Glycemic Breakfast Containing Oats and Mango, High-Glycemic Breakfast Containing Cereal and Mango and Low-Glycemic Breakfast Containing Oats and Table Sugar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to 1 Dec 2026
- 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 (females only)
- Not postmenopausal (females only).
- Not been diagnosed with cardiovascular disease.
- Not been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
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- Not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- Does not regularly take anti-inflammatory drugs (more than 2x week).
- Does not use glucose-lowering drugs (e.g., metformin)
- Does not use lipid-lowering drugs (e.g., statins)
- Does not use tobacco products or any illicit drugs.
- Does not have a pacemaker.
- Can consume mango, wheat, gluten, and milk.
- Can stay in a supine position in the dark 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 cardiovascular disease.
- Been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
Show all 14Show fewer
- Been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- Regularly take anti-inflammatory drugs (more than 2x week).
- Uses glucose-lowering drugs (e.g., metformin)
- Uses lipid-lowering drugs (e.g., statins)
- Uses tobacco products or any illicit drugs.
- 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 Sugar Substitute Within High and Low Glycemic Breakfasts on Postprandial Glucose and Insulin
Large blood sugar and insulin increases after meals high in table sugar are related to risk for diabetes and heart disease. Additionally, large increases in blood sugar may also negatively impact vascular health. Previous research suggests that mango consumed in small quantities has blood sugar-lowering properties, but the evidence of this within larger, more realistic meals is limited. 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 more favorable blood sugar, insulin, and vascular responses after eating breakfast meals. The investigators will compare the postprandial glycemic, insulinemic, and vascular response to low and high glycemic meals sweetened with either fresh mango or sucrose.
Read the detailed description
The investigators will recruit individuals with a BMI in the 18.5-35.0 kg/m2 range from the Ball State University campus and surrounding communities. Each participant will complete four meal trials in a randomized crossover design. At each meal trial, an intravenous catheter will be inserted and baseline blood sample collected. Brachial artery dilation will be measured using prior to the meal. Next, participants will consume one of four breakfast meals in a randomized crossover design: (1) cornflakes with 2% milk + fresh mango, (2) cornflakes with 2% milk + sucrose, (3) steel cut oats with water + fresh mango, and (4) steel cut oats with water + sucrose. Corn flakes based meals and oats based meals reflect high and low glycemic breakfasts, respectively. Within high and low glycemic meal conditions, total sugar from mango and sugar are matched, total energy is nearly identical (within 4 kcal), and macronutrients are matched.
After each meal, blood samples will be collected at the .5-, 1-, 2-, and 3-hour mark and brachial artery dilation (using the flow-mediated dilation technique) will be measured at 1-, 2-, and 3-hour marks. An acceptability survey (9-point hedonic scale) will be completed following the meal, and a satiety survey (the SLIM) will be filled out at baseline and .5-, 1-, 1.5-, 2-, 2.5-, and 3-hour mark. The investigators will measure metabolic markers (i.e., glucose, triglycerides, HDL-C) immediately after each sample collection using the Piccolo Xpress clinical chemical analyzer. Additional blood will be collected and stored as serum in order to measure insulin using commercially available ELISAs. Participants will complete a one-time DXA scan to measure body composition and bone density.
- Conditions
- Healthy Participants
- Being tested
- Low-Glycemic Breakfast Containing Oats and Mango, High-Glycemic Breakfast Containing Cereal and Mango, Low-Glycemic Breakfast Containing Oats and Table Sugar, High-Glycemic Breakfast Containing Cereal and Table Sugar
- Keywords
- glycemia, insulinemia, fresh mango, vascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Glycemic Breakfast Containing Oats and MangoOther
Low-glycemic breakfast of 80 grams of oats prepared with 473mL water and sweetened with 146 grams of mango.
High-Glycemic Breakfast Containing Cereal and MangoOther
High-glycemic breakfast of 84 grams of corn flakes prepared with 355mL of 2% milk and sweetened with 262 grams of mango.
Low-Glycemic Breakfast Containing Oats and Table SugarOther
Low-glycemic breakfast of 80 grams of oats prepared with 473mL of water and sweetened with 20 grams of table sugar.
High-Glycemic Breakfast Containing Cereal and Table SugarOther
High-glycemic breakfast of 84 grams of corn flakes prepared with 355mL of 2% milk and sweetened with 36 grams of table sugar.
| Study group | Role | What they receive |
|---|---|---|
| Cereal Consumption with Mango | Experimental | During the Cereal and 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 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 |
| Oat Consumption with Mango | Experimental | During the Oats and Mango Arm, participants will consume a bowl of oats prepared with water and sweetened with fresh mango. Receives: Other: Low-Glycemic Breakfast Containing Oats and Mango |
| Oat Consumption with Table Sugar | Experimental | During the Oat and Table Sugar arm, participants will consume a bowl of oats prepared with water and sweetened with table sugar. Receives: Other: Low-Glycemic Breakfast Containing Oats and Table Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
The investigators will measure glucose at baseline and .5-, 1-, 2-, and 3-hours 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 1.5 years.
Insulin
The investigators will measure insulin at baseline and .5- 1-, 2-, and 3-hours after each meal containing. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Flow-mediated Dilation
The investigators will measure FMD at baseline and 1-, 2-, and 3-hours after the 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 (4)
HDL-C
The investigators will measure HDL-C at baseline and .5-, 1-, 2-, and 3-hours 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.
Triglycerides
The investigators will measure triglycerides at baseline and .5-, 1-, 2-, and 3-hours 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 .5-, 1-, 1.5-, 2-, 2.5-, and 3-hours 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 posted1 Jul 2025
- Study start26 Mar 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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
- 24 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
- NCT07045051
- Sponsor's protocol ID
- IRB-FY2025-25
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 1 Jul 2025
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fresh Mango as a Sugar Substitute Within High and Low Glycemic Breakfasts on Postprandial Glucose and Insulin
- ClinicalTrials.gov ID
- NCT07045051
- Acronym / sponsor ID
- IRB-FY2025-25
- Conditions
- Healthy Participants
- Keywords
- glycemia, insulinemia, fresh mango, vascular health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Collaborators
- National Mango Board
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Jul 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.
Large blood sugar and insulin increases after meals high in table sugar are related to risk for diabetes and heart disease. Additionally, large increases in blood sugar may also negatively impact vascular health. Previous research suggests that mango consumed in small quantities has blood sugar-lowering properties, but the evidence of this within larger, more realistic meals is limited. 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 more favorable blood sugar, insulin, and vascular responses after eating breakfast meals. The investigators will compare the postprandial glycemic, insulinemic, and vascular response to low and high glycemic meals sweetened with either fresh mango or sucrose.
Detailed description
The investigators will recruit individuals with a BMI in the 18.5-35.0 kg/m2 range from the Ball State University campus and surrounding communities. Each participant will complete four meal trials in a randomized crossover design. At each meal trial, an intravenous catheter will be inserted and baseline blood sample collected. Brachial artery dilation will be measured using prior to the meal. Next, participants will consume one of four breakfast meals in a randomized crossover design: (1) cornflakes with 2% milk + fresh mango, (2) cornflakes with 2% milk + sucrose, (3) steel cut oats with water + fresh mango, and (4) steel cut oats with water + sucrose. Corn flakes based meals and oats based meals reflect high and low glycemic breakfasts, respectively. Within high and low glycemic meal conditions, total sugar from mango and sugar are matched, total energy is nearly identical (within 4 kcal), and macronutrients are matched.
After each meal, blood samples will be collected at the .5-, 1-, 2-, and 3-hour mark and brachial artery dilation (using the flow-mediated dilation technique) will be measured at 1-, 2-, and 3-hour marks. An acceptability survey (9-point hedonic scale) will be completed following the meal, and a satiety survey (the SLIM) will be filled out at baseline and .5-, 1-, 1.5-, 2-, 2.5-, and 3-hour mark. The investigators will measure metabolic markers (i.e., glucose, triglycerides, HDL-C) immediately after each sample collection using the Piccolo Xpress clinical chemical analyzer. Additional blood will be collected and stored as serum in order to measure insulin using commercially available ELISAs. Participants will complete a one-time DXA scan to measure body composition and bone density.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cereal Consumption with Mango | Experimental | Other: High-Glycemic Breakfast Containing Cereal and MangoDuring the Cereal and 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. |
| Oat Consumption with Mango | Experimental | Other: Low-Glycemic Breakfast Containing Oats and MangoDuring the Oats and Mango Arm, participants will consume a bowl of oats prepared with water and sweetened with fresh mango. |
| Oat Consumption with Table Sugar | Experimental | Other: Low-Glycemic Breakfast Containing Oats and Table SugarDuring the Oat and Table Sugar arm, participants will consume a bowl of oats prepared with water and sweetened with table sugar. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 18 - 45 years.
- Body mass index between 18.5-35.0 kg/m2
- Not pregnant (females only)
- Not postmenopausal (females only).
- Not been diagnosed with cardiovascular disease.
Key exclusion criteria (14 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 cardiovascular disease.
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-Glycemic Breakfast Containing Oats and MangoLow-glycemic breakfast of 80 grams of oats prepared with 473mL water and sweetened with 146 grams of mango. | Other | Oat Consumption with Mango |
| High-Glycemic Breakfast Containing Cereal and MangoHigh-glycemic breakfast of 84 grams of corn flakes prepared with 355mL of 2% milk and sweetened with 262 grams of mango. | Other | Cereal Consumption with Mango |
| Low-Glycemic Breakfast Containing Oats and Table SugarLow-glycemic breakfast of 80 grams of oats prepared with 473mL of water and sweetened with 20 grams of table sugar. | Other | Oat Consumption with Table Sugar |
| High-Glycemic Breakfast Containing Cereal and Table SugarHigh-glycemic breakfast of 84 grams of corn flakes prepared with 355mL of 2% milk and sweetened with 36 grams of table sugar. | Other | Cereal Consumption with Table Sugar |
Primary outcome
Glucose
Time frame: Through study completion, up to 1.5 years.
The investigators will measure glucose at baseline and .5-, 1-, 2-, and 3-hours after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Insulin
Time frame: Through study completion, up to 1.5 years.
The investigators will measure insulin at baseline and .5- 1-, 2-, and 3-hours after each meal containing. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Flow-mediated Dilation
Time frame: Through study completion, up to 1 year.
The investigators will measure FMD at baseline and 1-, 2-, and 3-hours after the meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
4 secondary outcomes
HDL-C
Time frame: Through study completion, up to 1 year.
Triglycerides
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 1 Jul 2025.
- 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 Low-Glycemic Breakfast Containing Oats and Mango, High-Glycemic Breakfast Containing Cereal and Mango and Low-Glycemic Breakfast Containing Oats 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 14 inclusion and 14 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 1 Jul 2025. 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?
Glucose (time frame: Through study completion, up to 1.5 years.). 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 1 Jul 2025.