NCT07650058

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Feb 2026

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 Progress54%
Feb 2026Jan 2027

Study Start

First participant enrolled

February 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

fresh mangoinflammationintestinal permeability

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Through study completion, up to 1 year.

Secondary Outcomes (3)

  • sCD14

    Through study completion, up to 1 year.

  • Acceptability

    Through study completion, up to 1 year.

  • Satiety

    Through study completion, up to 1 year.

Other Outcomes (1)

  • Body Composition

    Through study completion, up to 1 year.

Study Arms (2)

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.

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.

Other: High-Glycemic Breakfast Containing Cereal and Table Sugar

Interventions

High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 262 grams of fresh mango.

Cereal Consumption with Fresh Mango

High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 36 grams of table sugar.

Cereal Consumption with Table Sugar

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Professions Building, Ball State University

Muncie, Indiana, 47306, United States

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Dietary Sucrose

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SugarsDietary CarbohydratesCarbohydratesSucroseDisaccharidesOligosaccharidesPolysaccharidesSugarsNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bryant Keirns, PhD

    Ball State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryant Keirns, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 16, 2026

Study Start

February 1, 2026

Primary Completion

July 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

June 16, 2026

Record last verified: 2026-06

Locations