Effect of Mango Consumption on Individuals with Pre-diabetes

NCT ID: NCT05571800

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-07-31

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.

Conditions

PreDiabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mango Supplement

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

Group Type: EXPERIMENTAL

Mango

Intervention Type: OTHER

120g of fresh Mango

Placebo Matched Supplement

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

200g isocaloric Granola Bar

Interventions

Mango

120g of fresh Mango

Intervention Type: OTHER

Placebo

200g isocaloric Granola Bar

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Mango Board

OTHER

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Hickner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Hickner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

00002545

Identifier Type: -

Identifier Source: org_study_id