Optimizing Mango's Glycemic Impact: Investigating Mango Consumption Timing in Prediabetic Individuals

NCT06986161 | Recruiting

• 1 other identifier: 2025-95
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of mango intake on metabolic and inflammatory responses relative to meals in individuals at risk of developing diabetes, as well as to understand how the beneficial compounds found in mangoes are absorbed and processed in the body.

Conditions

Pre Diabetes

Outcome Measures

Primary Outcomes (6)

• Change in postprandial glucose

  Change in postprandial glucose as measured by absolute values and calculated insulin sensitivity using homeostasis model assessment of fasting insulin sensitivity (HOMA-%S) and B-cell function (HOMA-%).

  7 hours

• Change in postprandial glucose through peripheral insulin sensitivity

  Change in postprandial glucose as measured by assessment of peripheral insulin sensitivity using Matsuda index.

  7 hours

• Change in postprandial insulin

  Change in postprandial insulin as measured by absolute values and calculated insulin sensitivity using homeostasis model assessment of fasting insulin sensitivity (HOMA-%S) and B-cell function (HOMA-%).

  7 hours

• Change in postprandial insulin through peripheral insulin sensitivity

  Change in postprandial insulin as measured by assessment of peripheral insulin sensitivity using Matsuda index.

  7 hours

• Evaluate Interleukin-6 (IL-6) as an index of systemic inflammatory response

  Assessments to address this aim will include analysis of systemic markers of inflammation (IL-6) in plasma using ELISA method

  7 hours

• Evaluate Tumor Necrosis Factor-alpha (TNF-α) as an index of systemic inflammatory response

  Assessments to address this aim will include analysis of systemic markers of inflammation (TNF-α) in plasma using ELISA method

  7 hours

Secondary Outcomes (1)

• Characterize metabolite profiles

  7 hours

Study Arms (4)

Mango Before Meal

EXPERIMENTAL

1 cup (165 grams) of mango before standardized breakfast

Other: Mango

Mango With Meal

EXPERIMENTAL

1 cup (165 grams) of mango with standardized breakfast

Other: Mango

Mango After Meal

EXPERIMENTAL

1 cup (165 grams) of mango after standardized breakfast

Other: Mango

Control (no mango)

PLACEBO COMPARATOR

Control beverage (230 grams) with standardized breakfast

Other: Control Beverage

Interventions

Mango OTHER

Mango beverage

Mango After Meal; Mango Before Meal; Mango With Meal

Control Beverage OTHER

Italian Ice beverage

Control (no mango)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be between 20-60 years old.
• Have a BMI of 25-35 kilograms per square meter.
• Have fasting blood glucose between 100-125 milligrams per deciliter or Glycated hemoglobin (HbA1c) between 5.7-6.4%.
• Be non-smokers for at least 12 months.
• Be generally healthy, with no major organ-related diseases.
• Not take medications or supplements that could interfere with the study.
• Be able to follow study procedures, including dietary restrictions and scheduled visits.

You may not qualify if:

• Smoke, vape, or use marijuana.
• Have allergies or intolerance to mangoes or study foods.
• Have blood pressure above 160/100 millimeters of Mercury.
• Have fasting blood glucose above 125 milligrams per deciliter.
• Have a history of major heart disease, stroke, or cancer in the past five years.
• Be pregnant, planning to become pregnant, or breastfeeding.
• Take anti-inflammatory drugs or certain dietary supplements.
• Have had major surgery or trauma in the past two months.
• Follow extreme diets (e.g., vegan, Atkins).
• Have used antibiotics in the last six weeks.
• Have a history of eating disorders or substance abuse in the past two years.
• Drink more than three cups of coffee or tea per day.
• Have donated blood in the last three months.
• Be professional athletes or do excessive exercise.
• Have had weight changes of more than 11 pounds in the past two months.

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• National Mango Board: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Mangifera indica extract

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Indika Edirisinghe, PhD.

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

• Britt Burton-Freeman, PhD.

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandeep K. Sandhu, PhD.

CONTACT

708-563-1576; asandhu2@iit.edu

Chelsea Preiss, M.S.

CONTACT

312-567-5300; cpreiss@iit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The pilot study will use a single-blinded, randomized, 4-arm, within-subjects crossover design lasting approximately 5 weeks.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 22, 2025
• Study Start: April 14, 2025
• Primary Completion: April 13, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)