Clinical trial NCT06159543: The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
Official title: The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes: a Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperglycemia
Dyslipidemias
Insulin Resistance
Inflammation
Oxidative Stress
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: National Mango Board
First posted: 2023-12-06
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: LDL-cholesterol
timeFrame: LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: Total cholesterol
timeFrame: Total cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: HDL-cholesterol
timeFrame: HDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: Triglycerides
timeFrame: Triglycerides will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: HgbA1c
timeFrame: HgbA1c will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: Fasting blood glucose
timeFrame: Fasting blood glucose will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: Fasting blood insulin
timeFrame: Fasting blood insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: HOMA-IR (Insulin resistance)
timeFrame: Fasting blood glucose and insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: Oxidized LDL-cholesterol
timeFrame: Oxidized LDL-cholesterol will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: 8-iso-PGF2 alpha
timeFrame: 8-iso-PGF2 alpha will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Secondary outcomes:
measure: C-reactive protein
timeFrame: C-reactive protein will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: E-selectin
timeFrame: E-selectin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: ICAM
timeFrame: ICAM will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: VCAM
timeFrame: VCAM will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: TNF-alpha
timeFrame: TNF-alpha will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: IL-beta
timeFrame: IL-beta will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
measure: Percent body fat
timeFrame: Percent body fat will be measured at weeks 0, 4, 8, 12 of each phase of the study.
measure: Fat mass
timeFrame: Fat mass will be measured at weeks 0, 4, 8, 12 of each phase of the study.
measure: Lean body mass
timeFrame: Lean body mass will be measured at weeks 0, 4, 8, 12 of each phase of the study.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Nutrition Research Center, School of Public Health, Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Celine Heskey, DrPH
role: PRINCIPAL_INVESTIGATOR
References: