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

Inflammation Clinical Trial

Official title:

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes: a Randomized Controlled Crossover Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06159543
• Other study ID #: 5230515
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Loma Linda University
• Contact: Amandeep Wright, MPH
• Phone: (909) 558-4300
• Email: amawright[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 and VCAM?

• 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 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, 12, and 28 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, 16, 20, 24, and 28 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperglycemia
• Inflammation
• Insulin Resistance
• Oxidative Stress
• Prediabetic State

Intervention

Behavioral:
• Mango
1.5 cups/day of mango for 12 weeks

Locations

Country	Name	City	State
United States	Nutrition Research Center, School of Public Health, Loma Linda University	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	National Mango Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol		LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study.
Primary	Total cholesterol		Total cholesterol will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study.
Primary	HDL-cholesterol		HDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study.
Primary	Triglycerides		Triglycerides will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study.
Primary	HgbA1c		HgbA1c will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study.
Primary	Fasting blood glucose		Fasting blood glucose will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study.
Primary	Fasting blood insulin		Fasting blood insulin will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study.
Primary	HOMA-IR (Insulin resistance)	Fasting blood glucose and fasting blood insulin will be used to quantify HOMA-IR values.	Fasting blood glucose and insulin will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study, and used to quantify HOMA-IR values
Primary	Oxidized LDL-cholesterol		Oxidized LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study
Primary	8-iso-PGF2 alpha		8-iso-PGF2 alpha will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study
Secondary	C-reactive protein		C-reactive protein will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study
Secondary	E-selectin		E-selectin will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study
Secondary	ICAM		ICAM will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study
Secondary	VCAM		VCAM will be measured in fasting blood that will be drawn at weeks 0, 12, and 28 of the study
Secondary	Percent body fat		Percent body fat will be measured at weeks 0, 4, 8, 12, 16, 20, 24, 28
Secondary	Fat mass		Fat mass will be measured at weeks 0, 4, 8, 12, 16, 20, 24, 28
Secondary	Lean body mass		Lean body mass will be measured at weeks 0, 4, 8, 12, 16, 20, 24, 28