Clinical trial NCT05571800: Effect of Mango Consumption on Individuals with Pre-diabetes
Official title: The Effects of Fresh Mango Consumption in Indices of Glycemic Control, Cardiovascular Health, and Body Composition in Normal Weight, Overweight and Obese Individuals with Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Keywords: Glycemic Control
Cardiovascular Health
Overweight
Obese
Glycemic Indices
Body Composition
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Mango Board
First posted: 2022-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, calorie-match controlled
Primary purpose: OTHER

Brief summary: This study is designed to explore the effect of mango consumption on glycemic indices, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.

Detailed description: According to the Centers for Disease Control and Prevention (2016), at least 100 million adults in the United States are diagnosed as pre-diabetic or Type 2 diabetic. With the number of cases steadily increasing in this population, healthcare costs have subsequently increased for both the patient and the health care system. To date, there are few studies (limited to animal model and obese Type 2 diabetic humans) that have examined the efficacy of mangoes on health outcomes, particularly related to diabetes. Therefore, the purpose of the current study is to examine the effect of fresh mango on glycemic indices, body composition, and vascular health measures. Upon favorable outcomes, and with more definite evidence from human studies, mangoes can potentially be implemented in America's diet to help mitigate the advancement and diagnoses of pre and Type 2 diabetes and, as a result, aid in a reduction of healthcare costs. The current study is a 24- week, randomized, controlled experiment including 40 overweight or obese, pre-diabetic men and post-menopausal women aged 50 to 70 years with no diagnosed cardiovascular, metabolic, kidney, or other types of chronic disease to be included. Participants will be randomly assigned to one of two groups: 1) one fresh Tommy Atkins mango (120 g) per day or 2) an isocaloric granola bar per day for 24 weeks. Visits will include anthropometric measurements, glucose, and A1C values via finger prick, venous blood samples to analyze biomarkers related to glycemic control and lipid profiles, vascular measures, and body composition. To analyze the effects of the treatment, ANOVA and Bonferroni's test will be utilized. The investigators hypothesize that daily consumption of one mango per day for 24 weeks will improve the indices of glycemic control, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.

Eligibility criteria: Inclusion Criteria:

* Free of any chronic diseases such as cancer
* BMI of 18.5 kg/m2 to 34.9 kg/m2
* wHbA1c values are 100 mg/dl to 125 mg/dl and HbA1C of 5.7-6.4 %

Exclusion Criteria:

* Individuals diagnosed with cardiovascular diseases (CVD), type 2-diabetes, type 1 diabetes mellitus, other active chronic diseases such as cancer, asthma, glaucoma, kidney, liver and pancreatic disease
* Uncontrolled hypertension (≥160/100 mmHg)
* BMI \<18.5 kg/m2 or \>34.9 kg/m2
* Not post-menopausal or have been taking hormone replacement therapy for less than 3 months
* taking more than one anti-hypertensive or have been taking them for less than 3 months
* Participating in a weight loss program or having lost or gain ≥10% bodyweight within the last 6 months
* Smoke more than 1 pack/day
* Consumption of \>12 alcoholic drinks/week
* Frequent mango consumers (\>5 servings/2weeks)
* In concurrent participation with another investigational study
* Currently consuming any performance supplement (i.e. creatine, nitric oxide, whey/casein protein, branched chain amino acids).

  * None of the following special populations will be included: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, or prisoners.

Primary outcomes:
measure: Effect of mango consumption on glycemic control using blood glucose measures
timeFrame: 3 years
measure: Effect of mango consumption on glycemic control using HbA1c
timeFrame: 3 years
measure: Effect of mango consumption on glycemic control evaluated by Insulin
timeFrame: 3 years
measure: Effect of mango consumption on glycemic control evaluated by HOMA-IR
timeFrame: 3 years
measure: Effect of mango consumption on glycemic control evaluated by HOMA-β
timeFrame: 3 years
Secondary outcomes:
measure: Effect of mango consumption on indicators of cardiovascular health evaluated by systolic and diastolic blood pressure
timeFrame: 3 years
measure: Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with FMD
timeFrame: 3 years
measure: Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with PWV
timeFrame: 3 years
measure: Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with ET-1
timeFrame: 3 years
measure: Effect of mango consumption on indicators of cardiovascular health evaluated by biomarker of inflammation (C-reactive protein)
timeFrame: 3 years
measure: Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile
timeFrame: 3 years
measure: Atherogenic risk ratio (TC/HDL-C, LDLC/HDL-C, HDL-C/LDL-C)
timeFrame: 3 years
measure: Effect of mango consumption on body composition evaluated by lean mass
timeFrame: 3 years
measure: Effect of mango consumption on body composition evaluated by fat mass
timeFrame: 3 years
measure: Effect of mango consumption on body composition evaluated by phase angle (PA)
timeFrame: 3 years
measure: Effect of mango consumption on body composition evaluated by weight
timeFrame: 3 years
measure: Effect of mango consumption on anthropometric measure of Waist circumference (WC)
timeFrame: 3 years
measure: Effect of mango consumption on anthropometric measure of HC
timeFrame: 3 years
measure: Effect of mango consumption on anthropometric measure WC/HC ratio
timeFrame: 3 years
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Robert Hickner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: