Effect of Mango Consumption on Individuals With Pre-diabetes

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05571800
• Other study ID #: 00002545
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

Other:
• Mango
120g of fresh Mango
• Placebo
200g isocaloric Granola Bar

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	National Mango Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of mango consumption on glycemic control using blood glucose measures	Blood glucose measures evaluated with finger prick and blood glucose meter	3 years
Primary	Effect of mango consumption on glycemic control using HbA1c	HbA1c evaluated by finger prick and DCA analyzer	3 years
Primary	Effect of mango consumption on glycemic control evaluated by Insulin	Insulin evaluated by blood draw Enzyme-linked immunosorbent assay	3 years
Primary	Effect of mango consumption on glycemic control evaluated by HOMA-IR	HOMA-IR evaluated by blood draw 20 ml Enzyme-linked immunosorbent assay	3 years
Primary	Effect of mango consumption on glycemic control evaluated by HOMA-ß	HOMA-ß evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay	3 years
Secondary	Effect of mango consumption on indicators of cardiovascular health evaluated by systolic and diastolic blood pressure	Systolic and diastolic blood pressure evaluated by automated blood pressure monitor	3 years
Secondary	Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with FMD	Flow-mediated dilation (FMD) evaluated with high-resolution doppler ultrasound (HD11XE, Phillips Ultrasound, Bothwell, WA, USA) with a 3-12 MHz linear array transducer	3 years
Secondary	Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with PWV	Pulse wave velocity (PWV) evaluated with Sphygmocor for pulse wave velocity, aortic blood pressure and augmentation index	3 years
Secondary	Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with ET-1	Endothelin-1 (ET-1) evaluated with Enzyme-linked immunosorbent assay	3 years
Secondary	Effect of mango consumption on indicators of cardiovascular health evaluated by biomarker of inflammation (C-reactive protein)	biomarker of inflammation (C-reactive protein) evaluated by blood draw 20 ml and enzyme-linked immunosorbent assay	3 years
Secondary	Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile	lipid profile evaluated by blood draw and enzyme-linked immunosorbent assay consisting of; Triglycerides (TG); Total cholesterol (TC); Low-density lipoprotein cholesterol (LDL-C); Oxidized LDL (Ox-LDL); High-density lipoprotein cholesterol (HDL-C)	3 years
Secondary	Atherogenic risk ratio (TC/HDL-C, LDLC/HDL-C, HDL-C/LDL-C)	Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile	3 years
Secondary	Effect of mango consumption on body composition evaluated by lean mass	Lean mass evaluated by bioimpedance spectroscopy (BIS)	3 years
Secondary	Effect of mango consumption on body composition evaluated by fat mass	fat mass evaluated by bioimpedance spectroscopy (BIS)	3 years
Secondary	Effect of mango consumption on body composition evaluated by phase angle (PA)	Phase angle (PA) calculated directly from reactance and resistance using the following formula: PA=arctangent reactance(ohm)/resistance (ohm) ×180°/p	3 years
Secondary	Effect of mango consumption on body composition evaluated by weight	Weight evaluated by Ohaus Portable Electronic CS Series Scales	3 years
Secondary	Effect of mango consumption on anthropometric measure of Waist circumference (WC)	evaluated by Gulick fiberglass measuring tape with a tension handle	3 years
Secondary	Effect of mango consumption on anthropometric measure of HC	hip circumference (HC) evaluated by Gulick fiberglass measuring tape with a tension handle	3 years
Secondary	Effect of mango consumption on anthropometric measure WC/HC ratio	waist to hip ratio (WC/HC)	3 years