Glycemic/Insulinemic Effects of Fresh Mango as a Sugar Substitute in Realistic Breakfasts.

NCT07045051 | Recruiting DMC

• 1 other identifier: IRB-FY2025-25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Participants

Keywords

glycemia; insulinemia; fresh mango; vascular health

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through study completion, up to 1 year.

Secondary Outcomes (4)

• HDL-C

  Through study completion, up to 1 year.

• Triglycerides

  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 (2)

• Body Composition

  Through study completion, up to 1 year.

• Systolic and Diastolic Pressure

  Through study completion, up to 1 year.

Study Arms (4)

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.

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.

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.

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.

Other: Low-Glycemic Breakfast Containing Oats and Table Sugar

Interventions

Low-Glycemic Breakfast Containing Oats and Mango OTHER

Low-glycemic breakfast of 80 grams of oats prepared with 473mL water and sweetened with 146 grams of mango.

Oat Consumption with Mango

High-Glycemic Breakfast Containing Cereal and Mango OTHER

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

Cereal Consumption with Mango

Low-Glycemic Breakfast Containing Oats and Table Sugar OTHER

Low-glycemic breakfast of 80 grams of oats prepared with 473mL of water and sweetened with 20 grams of table sugar.

Oat Consumption with Table Sugar

High-Glycemic Breakfast Containing Cereal and Table Sugar OTHER

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

Cereal Consumption with Table Sugar

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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.

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 cardiovascular disease.
• Been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
• 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.

Sponsors & Collaborators

• Ball State University: lead
• National Mango Board: collaborator

Study Sites (1)

Health Professions Building, Ball State University

Muncie, Indiana, 47306, United States

RECRUITING

MeSH Terms

Interventions

Mangifera indica extract; Dietary Sucrose

Intervention Hierarchy (Ancestors)

Dietary Sugars; Dietary Carbohydrates; Carbohydrates; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Sugars; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bryant Keirns, PhD

  Ball State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryant Keirns, PhD

CONTACT

765-285-8356; bryant.keirns@bsu.edu

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 24, 2025
• First Posted: July 1, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (1)