Effect of Mango Consumption on Individuals with Pre-diabetes
November 17, 2024 updated by: Hickner, Florida State University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Florida State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mango Supplement
Participants will consume 120g of fresh mango per day for 24 weeks
|
120g of fresh Mango
|
|
Placebo Comparator: Placebo Matched Supplement
Participants will consume 200g isocaloric granola bar per day for 24 weeks
|
200g isocaloric Granola Bar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of mango consumption on glycemic control using blood glucose measures
Time Frame: 3 years
|
Blood glucose measures evaluated with finger prick and blood glucose meter
|
3 years
|
|
Effect of mango consumption on glycemic control using HbA1c
Time Frame: 3 years
|
HbA1c evaluated by finger prick and DCA analyzer
|
3 years
|
|
Effect of mango consumption on glycemic control evaluated by Insulin
Time Frame: 3 years
|
Insulin evaluated by blood draw Enzyme-linked immunosorbent assay
|
3 years
|
|
Effect of mango consumption on glycemic control evaluated by HOMA-IR
Time Frame: 3 years
|
HOMA-IR evaluated by blood draw 20 ml Enzyme-linked immunosorbent assay
|
3 years
|
|
Effect of mango consumption on glycemic control evaluated by HOMA-β
Time Frame: 3 years
|
HOMA-β evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of mango consumption on indicators of cardiovascular health evaluated by systolic and diastolic blood pressure
Time Frame: 3 years
|
Systolic and diastolic blood pressure evaluated by automated blood pressure monitor
|
3 years
|
|
Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with FMD
Time Frame: 3 years
|
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
|
|
Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with PWV
Time Frame: 3 years
|
Pulse wave velocity (PWV) evaluated with Sphygmocor for pulse wave velocity, aortic blood pressure and augmentation index
|
3 years
|
|
Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with ET-1
Time Frame: 3 years
|
Endothelin-1 (ET-1) evaluated with Enzyme-linked immunosorbent assay
|
3 years
|
|
Effect of mango consumption on indicators of cardiovascular health evaluated by biomarker of inflammation (C-reactive protein)
Time Frame: 3 years
|
biomarker of inflammation (C-reactive protein) evaluated by blood draw 20 ml and enzyme-linked immunosorbent assay
|
3 years
|
|
Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile
Time Frame: 3 years
|
lipid profile evaluated by blood draw and enzyme-linked immunosorbent assay consisting of
|
3 years
|
|
Atherogenic risk ratio (TC/HDL-C, LDLC/HDL-C, HDL-C/LDL-C)
Time Frame: 3 years
|
Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile
|
3 years
|
|
Effect of mango consumption on body composition evaluated by lean mass
Time Frame: 3 years
|
Lean mass evaluated by bioimpedance spectroscopy (BIS)
|
3 years
|
|
Effect of mango consumption on body composition evaluated by fat mass
Time Frame: 3 years
|
fat mass evaluated by bioimpedance spectroscopy (BIS)
|
3 years
|
|
Effect of mango consumption on body composition evaluated by phase angle (PA)
Time Frame: 3 years
|
Phase angle (PA) calculated directly from reactance and resistance using the following formula: PA=arctangent reactance(ohm)/resistance (ohm) ×180°/π
|
3 years
|
|
Effect of mango consumption on body composition evaluated by weight
Time Frame: 3 years
|
Weight evaluated by Ohaus Portable Electronic CS Series Scales
|
3 years
|
|
Effect of mango consumption on anthropometric measure of Waist circumference (WC)
Time Frame: 3 years
|
evaluated by Gulick fiberglass measuring tape with a tension handle
|
3 years
|
|
Effect of mango consumption on anthropometric measure of HC
Time Frame: 3 years
|
hip circumference (HC) evaluated by Gulick fiberglass measuring tape with a tension handle
|
3 years
|
|
Effect of mango consumption on anthropometric measure WC/HC ratio
Time Frame: 3 years
|
waist to hip ratio (WC/HC)
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Hickner, Ph.D., Florida State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
July 31, 2024
Study Completion (Actual)
July 31, 2024
Study Registration Dates
First Submitted
September 6, 2022
First Submitted That Met QC Criteria
October 6, 2022
First Posted (Actual)
October 7, 2022
Study Record Updates
Last Update Posted (Estimated)
November 20, 2024
Last Update Submitted That Met QC Criteria
November 17, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00002545
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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