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PreDiabetesNCT05571800

Effect of Mango Consumption on Individuals with Pre-diabetes

A study testing Mango in people with PreDiabetes and Obesity, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
PreDiabetes, Obesity
What is being tested?
Mango
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
1 May 2022to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 %

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Florida State University

    Tallahassee, Florida, 32306

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Mango, Placebo
Keywords
Glycemic Control, Cardiovascular Health, Overweight, Obese, Glycemic Indices, Body Composition
Medical subject headings
Prediabetic State, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MangoOther

    120g of fresh Mango

  • PlaceboOther

    200g isocaloric Granola Bar

Study groups in NCT05571800
Study groupRoleWhat they receive
Mango SupplementExperimentalParticipants will consume 120g of fresh mango per day for 24 weeks
Receives: Other: Mango
Placebo Matched SupplementPlacebo comparatorParticipants will consume 200g isocaloric granola bar per day for 24 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of mango consumption on glycemic control using blood glucose measures

    Blood glucose measures evaluated with finger prick and blood glucose meter

    Measured: 3 years

  2. Effect of mango consumption on glycemic control using HbA1c

    HbA1c evaluated by finger prick and DCA analyzer

    Measured: 3 years

  3. Effect of mango consumption on glycemic control evaluated by Insulin

    Insulin evaluated by blood draw Enzyme-linked immunosorbent assay

    Measured: 3 years

  4. Effect of mango consumption on glycemic control evaluated by HOMA-IR

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

    Measured: 3 years

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

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

    Measured: 3 years

Secondary outcomes (14)

  1. 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

    Measured: 3 years

  2. 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

    Measured: 3 years

  3. 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

    Measured: 3 years

  4. 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

    Measured: 3 years

  5. 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

    Measured: 3 years

  6. 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)

    Measured: 3 years

  7. 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

    Measured: 3 years

  8. Effect of mango consumption on body composition evaluated by lean mass

    Lean mass evaluated by bioimpedance spectroscopy (BIS)

    Measured: 3 years

  9. Effect of mango consumption on body composition evaluated by fat mass

    fat mass evaluated by bioimpedance spectroscopy (BIS)

    Measured: 3 years

  10. 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

    Measured: 3 years

  11. Effect of mango consumption on body composition evaluated by weight

    Weight evaluated by Ohaus Portable Electronic CS Series Scales

    Measured: 3 years

  12. Effect of mango consumption on anthropometric measure of Waist circumference (WC)

    evaluated by Gulick fiberglass measuring tape with a tension handle

    Measured: 3 years

  13. Effect of mango consumption on anthropometric measure of HC

    hip circumference (HC) evaluated by Gulick fiberglass measuring tape with a tension handle

    Measured: 3 years

  14. Effect of mango consumption on anthropometric measure WC/HC ratio

    waist to hip ratio (WC/HC)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2022
  2. Study start1 May 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, calorie-match controlled
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05571800
Sponsor's protocol ID
00002545
Status last verified
Oct 2024
First submitted
6 Sep 2022
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mango in people with PreDiabetes and Obesity, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of mango consumption on glycemic control using blood glucose measures (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05571800.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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