Mango for Prediabetes

Overseen By Celine Heskey, DrPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Glycemic, Lipid supplements

Disqualifiers: Diabetes, Heart disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating 1.5 cups of fresh mango (Mangifera indica, commonly known as Tommy Atkins mango) daily for 12 weeks can improve health markers in people with prediabetes. Researchers aim to determine if mango can help control blood sugar, reduce inflammation, and improve cholesterol levels and body composition. Participants will consume mango for 12 weeks, take a break, and then avoid it for another 12 weeks to compare results. The trial suits individuals with prediabetes and abdominal obesity who do not have chronic diseases or mango allergies. As an unphased trial, it offers a unique opportunity to contribute to the scientific understanding of dietary impacts on prediabetes.

Will I have to stop taking my current medications?

The trial requires that participants do not use medications or supplements that affect blood sugar levels or cholesterol. If you are taking such medications, you may need to stop them to participate.

Is there any evidence suggesting that consuming mango is safe for individuals with prediabetes?

Research has shown that eating mango is safe for people. In one study, participants ate mango daily for 24 weeks and experienced better blood sugar control and less insulin resistance, without any negative effects on weight or health. Another study found that eating freeze-dried mango did not cause weight gain and also helped with blood sugar levels. Additionally, an animal study using high doses of mango extract showed no harmful effects. Overall, these studies suggest that mango is well-tolerated and does not cause health problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prediabetes, which often include medications like metformin and lifestyle changes such as diet and exercise, consuming mango as a treatment is unique because it leverages a natural food source with potential health benefits. Mangoes are rich in fiber, vitamins, and antioxidants, which might help improve blood sugar control and insulin sensitivity. Researchers are excited about this approach because it offers a simple, dietary-based intervention that could be easily incorporated into daily life, possibly providing an alternative or complementary option to traditional medical treatments.

What evidence suggests that mango might be an effective treatment for prediabetes?

In this trial, participants will either add mango to their habitual diet or continue their habitual diet without mango. A previous study showed that eating mango daily for 24 weeks helped people with prediabetes control their blood sugar and reduce insulin resistance. Research has also shown that mango can aid in body composition, potentially helping manage body fat and muscle. Another study found that the "Tommy Atkins" mango variety improved blood sugar response and body composition. These findings suggest that mango could help manage prediabetes by improving blood sugar levels and overall metabolic health. ^{1 2 3 6 7}

Who Is on the Research Team?

Celine Heskey, DrPH

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for individuals with prediabetes, indicated by HgbA1c levels of 5.7 to 6.4%, and abdominal obesity (waist >102 cm for men, >88 cm for women). Excluded are those with chronic diseases, pacemakers, mango or latex allergies, smokers, high alcohol consumers (>2 drinks/day for men or >1 drink/day for women), recent significant weight loss (>5% in past 6 months), BMI over 35 kg/m^2, pregnant or breastfeeding women, on certain medications/supplements affecting blood sugar/lipids or who regularly consume lots of mangos/fruits.

Inclusion Criteria

My waist is over 102 cm if I am a man, or over 88 cm if I am a woman.

HgbA1c of 5.7 to 6.4% indicative of prediabetes

Exclusion Criteria

Pregnancy or lactation

Habitual mango intake of >3 servings per week and/or habitual fruit intake of >2 servings per day

I have a chronic condition like diabetes or heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Prerandomization

Participants attend a prerandomization clinic prior to study

1 day

1 visit (in-person)

Mango Consumption Phase

Participants consume 1.5 cups of mango per day for 12 weeks

12 weeks

4 visits (in-person) for anthropometric measurements and blood draws

Washout Period

Participants take a 4 to 8 week break from mango consumption

4-8 weeks

No Mango Consumption Phase

Participants avoid consuming mangos for 12 weeks

12 weeks

4 visits (in-person) for anthropometric measurements and blood draws

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mango

Trial Overview The study tests if eating 1.5 cups of fresh mango daily over a period of 12 weeks can improve glucose control and insulin resistance in people with prediabetes. It also looks at the effects on cholesterol levels (LDL/HDL/total/triglycerides), oxidative stress markers like oxidized LDL-cholesterol and inflammation indicators such as c-reactive protein. Participants will alternate between consuming mangos and not consuming them to compare changes.

How Is the Trial Designed?

Group I: Mango added to habitual diet Experimental Treatment 1 Intervention

Participants will be asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet.

Group II: Habitual diet without mango Active Control 1 Intervention

Participants will be asked to refrain consuming mangos for 12 weeks while continuing their habitual diet.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

National Mango Board

Collaborator

Trials

7

Recruited

300+

Published Research Related to This Trial

In a study of 27 individuals with overweight and obesity consuming 280 g of mango pulp daily for 8 weeks, there was a significant 3.5% reduction in systolic blood pressure and a 10.5% reduction in 2-hour plasma glucose levels, indicating potential cardiometabolic benefits.

Mango consumption also led to enhanced gut microbiota diversity and changes in specific gut bacterial species, suggesting a link between mango intake and improved gut health, which may contribute to the observed health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in systolic blood pressure, postprandial glucose, and gut microbial composition following mango consumption in individuals with overweight and obesity. Keathley, J., Kearney, M., Garneau, V., et al.[2022]

A 90-day toxicity study in Sprague Dawley rats showed that a hot-water extract of thinned immature mango fruits (TIMEx) is safe for consumption, with no deaths or significant behavioral changes observed at doses up to 2500 mg/kg body weight/day.

The study established a no-observed-adverse-effect level (NOAEL) of 2500 mg/kg/day for TIMEx, suggesting it could be a viable candidate for food applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subchronic safety evaluation of hot-water extract from thinned immature mangos (Mangifera indica 'Irwin'): 90-days oral toxicity study in rats. Tajiri, H., Tanaka, W., Takashima, M., et al.[2021]

In a 26-week pilot study involving 22 obese female patients, those who received mangosteen extract alongside behavioral therapy showed a significant improvement in insulin sensitivity, with a reduction in insulin resistance of 53.22% compared to 15.23% in the control group.

The study reported no adverse side effects from the mangosteen treatment, suggesting it has a strong safety profile and may serve as a beneficial supplement in managing obesity and insulin resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mangosteen Extract Shows a Potent Insulin Sensitizing Effect in Obese Female Patients: A Prospective Randomized Controlled Pilot Study. Watanabe, M., Gangitano, E., Francomano, D., et al.[2018]

A systematic review of 28 studies found that various parts of the mango plant, including leaves and flesh, exhibit glucose-lowering properties, suggesting potential benefits for managing type 2 diabetes in both animal models and humans.

The proposed mechanisms for mango's antidiabetic effects include inhibition of enzymes that break down carbohydrates, improved insulin sensitivity, and enhanced glucose uptake, although more research is needed to fully understand these mechanisms and their effectiveness in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiabetic properties of mango in animal models and humans: A systematic review. Zarasvand, SA., Mullins, AP., Arjmandi, B., et al.[2023]

In a pilot study of 20 obese adults over 12 weeks, supplementation with 10 g/day of freeze-dried mango significantly reduced fasting blood glucose levels in both males and females, indicating potential benefits for blood sugar management.

While there were no significant changes in overall body weight or composition, males experienced a notable reduction in hip circumference, suggesting that mango supplementation may help with specific body measurements without negatively affecting weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mango supplementation improves blood glucose in obese individuals. Evans, SF., Meister, M., Mahmood, M., et al.[2022]

Mango consumers, both children and adults, showed significantly better nutrient intakes and diet quality, including higher levels of dietary fiber, vitamins, and lower intakes of added sugars and cholesterol compared to non-consumers.

In children and male adults, mango consumption was linked to lower BMI and waist circumference, suggesting potential health benefits associated with including mangoes in the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mango Consumption Is Associated with Improved Nutrient Intakes, Diet Quality, and Weight-Related Health Outcomes. Papanikolaou, Y., Fulgoni, VL.[2022]

The ethanolic extract of mango leaves significantly reduced serum glucose and triglyceride levels in KK-A(y) mice, indicating its potential as a natural treatment for managing blood sugar and lipid levels.

The beneficial effects of mango leaf extract are linked to the activation of the PI3K/AKT and AMPK signaling pathways, which enhance glucose metabolism and alter lipid metabolism by regulating key genes involved in these processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of lipid and glucose homeostasis by mango tree leaf extract is mediated by AMPK and PI3K/AKT signaling pathways. Zhang, Y., Liu, X., Han, L., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12428706/

Daily Mango Intake Improves Glycemic and Body ... In conclusion, daily consumption of mango for 24 weeks improved both short- and long-term blood glucose control, reduced insulin resistance, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05571800

Study Details | NCT05571800 | Effect of Mango ... The investigators hypothesize that daily consumption of one mango per day for 24 weeks will improve the indices of glycemic control, cardiovascular health, and ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05571800/effect-of-mango-consumption-on-individuals-with-pre-diabetes

Effect of Mango Consumption on Individuals with Pre- ... The investigators hypothesize that daily consumption of one mango per day for 24 weeks will improve the indices of glycemic control, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4155986/

Mango Supplementation Improves Blood Glucose in ... The “Tommy Atkins” variety of mango was chosen for this study since this is the variety that demonstrated improved body composition and glucose response in our ...

5. researchgate.net researchgate.net/publication/394996751_Daily_Mango_Intake_Improves_Glycemic_and_Body_Composition_Outcomes_in_Adults_with_Prediabetes_A_Randomized_Controlled_Study

(PDF) Daily Mango Intake Improves Glycemic and Body ... Conclusions: The daily consumption of mango for 24 weeks improved the glycemic control, insulin sensitivity, and body composition in adults with ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S093947532100541X

Effects of fresh mango consumption on cardiometabolic ... Mangos may improve certain risk factors associated with overweight and obesity including improved glycemic control and reduced inflammation.

7. withpower.com withpower.com/trial/phase-hyperglycemia-2024-2d530

Mango for Prediabetes · Info for Participants Studies have shown no negative effects on body weight or health markers, and a 90-day study in rats found no harmful effects at high doses of mango extract. ...