The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

Loma Linda University (LLU)

Status: Active, not recruiting

Conditions: Inflammation; Hyperglycemia; Dyslipidemias; Insulin Resistance; Oxidative Stress

Treatments: Behavioral: Mango

Study type: Interventional

Funder types: Other

Identifiers

NCT06159543

5230515

Details and patient eligibility

About

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are:

• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM, VCAM, TNF-alpha and IL-beta?
• What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass?

Participants will be asked to:

• Consume 1.5 cups of mango per day for 12 weeks, take a 4 to 8 week break, and then avoid consuming mangos for 12 weeks
• Attend a prerandomization clinic prior to study
• Attend three (3) clinics where blood will be drawn during weeks 0, and 12 of the first phase and last week of the second phase of the study
• Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12 of each phase of the study
• Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls.

Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.

Enrollment: 31 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HgbA1c of 5.7 to 6.4% indicative of prediabetes
• Abdominal obesity as defined as a waist circumference >102 cm for men or >88 cm for women

Exclusion criteria

• Self-reported chronic disease history (diabetes, heart disease, cancer, kidney disease, inflammatory bowel disease, etc.)
• Pacemaker
• Mango allergies
• Latex allergies (cross-reactive with mango)
• Smoking, use of tobacco, or high alcohol intake (>2 drinks/day for men or >1 drink per day for women)
• Recent significant weight loss (>5% within 6 months of study enrollment)
• BMI >35 kg/m^2
• Pregnancy or lactation
• Use of medication and/or supplements affecting glycemic indicators or lipids
• Habitual mango intake of >3 servings per week and/or habitual fruit intake of >2 servings per day
• Not able to read and/or communicate in English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Mango added to habitual diet

Experimental group

Description:

Participants will be asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet.

Treatment:

Behavioral: Mango

Habitual diet without mango

No Intervention group

Description:

Participants will be asked to refrain consuming mangos for 12 weeks while continuing their habitual diet.