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Effect of Mango Consumption on Individuals With Pre-diabetes

Primary Purpose

PreDiabetes, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mango
Placebo
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PreDiabetes focused on measuring Glycemic Control, Cardiovascular Health, Overweight, Obese, Glycemic Indices, Body Composition

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Florida State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mango Supplement

Placebo Matched Supplement

Arm Description

Participants will consume 120g of fresh mango per day for 24 weeks

Participants will consume 200g isocaloric granola bar per day for 24 weeks

Outcomes

Primary Outcome Measures

Effect of mango consumption on glycemic control using blood glucose measures
Blood glucose measures evaluated with finger prick and blood glucose meter
Effect of mango consumption on glycemic control using HbA1c
HbA1c evaluated by finger prick and DCA analyzer
Effect of mango consumption on glycemic control evaluated by Insulin
Insulin evaluated by blood draw Enzyme-linked immunosorbent assay
Effect of mango consumption on glycemic control evaluated by HOMA-IR
HOMA-IR evaluated by blood draw 20 ml Enzyme-linked immunosorbent assay
Effect of mango consumption on glycemic control evaluated by HOMA-β
HOMA-β evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay

Secondary Outcome Measures

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
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
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
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
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
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)
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
Effect of mango consumption on body composition evaluated by lean mass
Lean mass evaluated by bioimpedance spectroscopy (BIS)
Effect of mango consumption on body composition evaluated by fat mass
fat mass evaluated by bioimpedance spectroscopy (BIS)
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°/π
Effect of mango consumption on body composition evaluated by weight
Weight evaluated by Ohaus Portable Electronic CS Series Scales
Effect of mango consumption on anthropometric measure of Waist circumference (WC)
evaluated by Gulick fiberglass measuring tape with a tension handle
Effect of mango consumption on anthropometric measure of HC
hip circumference (HC) evaluated by Gulick fiberglass measuring tape with a tension handle
Effect of mango consumption on anthropometric measure WC/HC ratio
waist to hip ratio (WC/HC)

Full Information

First Posted
September 6, 2022
Last Updated
October 6, 2022
Sponsor
Florida State University
Collaborators
National Mango Board
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1. Study Identification

Unique Protocol Identification Number
NCT05571800
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Mango Board

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Obesity
Keywords
Glycemic Control, Cardiovascular Health, Overweight, Obese, Glycemic Indices, Body Composition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, calorie-match controlled
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mango Supplement
Arm Type
Experimental
Arm Description
Participants will consume 120g of fresh mango per day for 24 weeks
Arm Title
Placebo Matched Supplement
Arm Type
Placebo Comparator
Arm Description
Participants will consume 200g isocaloric granola bar per day for 24 weeks
Intervention Type
Other
Intervention Name(s)
Mango
Intervention Description
120g of fresh Mango
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
200g isocaloric Granola Bar
Primary Outcome Measure Information:
Title
Effect of mango consumption on glycemic control using blood glucose measures
Description
Blood glucose measures evaluated with finger prick and blood glucose meter
Time Frame
3 years
Title
Effect of mango consumption on glycemic control using HbA1c
Description
HbA1c evaluated by finger prick and DCA analyzer
Time Frame
3 years
Title
Effect of mango consumption on glycemic control evaluated by Insulin
Description
Insulin evaluated by blood draw Enzyme-linked immunosorbent assay
Time Frame
3 years
Title
Effect of mango consumption on glycemic control evaluated by HOMA-IR
Description
HOMA-IR evaluated by blood draw 20 ml Enzyme-linked immunosorbent assay
Time Frame
3 years
Title
Effect of mango consumption on glycemic control evaluated by HOMA-β
Description
HOMA-β evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Effect of mango consumption on indicators of cardiovascular health evaluated by systolic and diastolic blood pressure
Description
Systolic and diastolic blood pressure evaluated by automated blood pressure monitor
Time Frame
3 years
Title
Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with FMD
Description
Flow-mediated dilation (FMD) evaluated with high-resolution doppler ultrasound (HD11XE, Phillips Ultrasound, Bothwell, WA, USA) with a 3-12 MHz linear array transducer
Time Frame
3 years
Title
Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with PWV
Description
Pulse wave velocity (PWV) evaluated with Sphygmocor for pulse wave velocity, aortic blood pressure and augmentation index
Time Frame
3 years
Title
Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with ET-1
Description
Endothelin-1 (ET-1) evaluated with Enzyme-linked immunosorbent assay
Time Frame
3 years
Title
Effect of mango consumption on indicators of cardiovascular health evaluated by biomarker of inflammation (C-reactive protein)
Description
biomarker of inflammation (C-reactive protein) evaluated by blood draw 20 ml and enzyme-linked immunosorbent assay
Time Frame
3 years
Title
Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile
Description
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)
Time Frame
3 years
Title
Atherogenic risk ratio (TC/HDL-C, LDLC/HDL-C, HDL-C/LDL-C)
Description
Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile
Time Frame
3 years
Title
Effect of mango consumption on body composition evaluated by lean mass
Description
Lean mass evaluated by bioimpedance spectroscopy (BIS)
Time Frame
3 years
Title
Effect of mango consumption on body composition evaluated by fat mass
Description
fat mass evaluated by bioimpedance spectroscopy (BIS)
Time Frame
3 years
Title
Effect of mango consumption on body composition evaluated by phase angle (PA)
Description
Phase angle (PA) calculated directly from reactance and resistance using the following formula: PA=arctangent reactance(ohm)/resistance (ohm) ×180°/π
Time Frame
3 years
Title
Effect of mango consumption on body composition evaluated by weight
Description
Weight evaluated by Ohaus Portable Electronic CS Series Scales
Time Frame
3 years
Title
Effect of mango consumption on anthropometric measure of Waist circumference (WC)
Description
evaluated by Gulick fiberglass measuring tape with a tension handle
Time Frame
3 years
Title
Effect of mango consumption on anthropometric measure of HC
Description
hip circumference (HC) evaluated by Gulick fiberglass measuring tape with a tension handle
Time Frame
3 years
Title
Effect of mango consumption on anthropometric measure WC/HC ratio
Description
waist to hip ratio (WC/HC)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahram Arjmandi, Ph.D.
Phone
(850) 645-1517
Email
barjmandi@fsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kallie Dawkins, MS
Phone
8505566251
Email
ked17h@fsu.edu
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahram Arjmandi, Ph.D.
Phone
850-645-1517
Email
barjmandi@fsu.edu
First Name & Middle Initial & Last Name & Degree
Kallie Dawkins, MS
Phone
8505566251
Email
ked17h@fsu.edu

12. IPD Sharing Statement

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Effect of Mango Consumption on Individuals With Pre-diabetes

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