Effect of Mango Consumption on Individuals with Pre-diabetes

NCT05571800 | Completed

• 1 other identifier: 00002545
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Obesity

Keywords

Glycemic Control; Cardiovascular Health; Overweight; Obese; Glycemic Indices; Body Composition

Outcome Measures

Primary Outcomes (5)

• Effect of mango consumption on glycemic control using blood glucose measures

  Blood glucose measures evaluated with finger prick and blood glucose meter

  3 years

• Effect of mango consumption on glycemic control using HbA1c

  HbA1c evaluated by finger prick and DCA analyzer

  3 years

• Effect of mango consumption on glycemic control evaluated by Insulin

  Insulin evaluated by blood draw Enzyme-linked immunosorbent assay

  3 years

• 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

• Effect of mango consumption on glycemic control evaluated by HOMA-β

  HOMA-β evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay

  3 years

Secondary Outcomes (14)

• Effect of mango consumption on indicators of cardiovascular health evaluated by systolic and diastolic blood pressure

  3 years

• Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with FMD

  3 years

• Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with PWV

  3 years

• Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with ET-1

  3 years

• Effect of mango consumption on indicators of cardiovascular health evaluated by biomarker of inflammation (C-reactive protein)

  3 years

Study Arms (2)

Mango Supplement

EXPERIMENTAL

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

Other: Mango

Placebo Matched Supplement

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Mango OTHER

120g of fresh Mango

Mango Supplement

Placebo OTHER

200g isocaloric Granola Bar

Placebo Matched Supplement

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead
• National Mango Board: collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Prediabetic State; Obesity; Overweight

Interventions

Mangifera indica extract

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Hickner, Ph.D.

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, calorie-match controlled

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: October 7, 2022
• Study Start: May 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-10

Locations

US (1)