Mango for Prediabetes

Overseen by Celine Heskey, DrPH

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Loma Linda University

Must not be taking: Glycemic, Lipid supplements

Disqualifiers: Diabetes, Heart disease, Cancer, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are: * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM, VCAM, TNF-alpha and IL-beta? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass? Participants will be asked to: * Consume 1.5 cups of mango per day for 12 weeks, take a 4 to 8 week break, and then avoid consuming mangos for 12 weeks * Attend a prerandomization clinic prior to study * Attend three (3) clinics where blood will be drawn during weeks 0, and 12 of the first phase and last week of the second phase of the study * Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12 of each phase of the study * Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls. Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.

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.

What data supports the effectiveness of the treatment Mango, Mangifera indica, Tommy Atkins mango for prediabetes?

Research suggests that mango has compounds that may help lower blood sugar levels, as seen in studies with both animals and humans. Additionally, a study found that consuming freeze-dried mango reduced blood glucose levels in obese individuals, indicating potential benefits for managing blood sugar. ^{1 2 3 4 5}

Is mango safe for human consumption?

Research suggests that mango is generally safe for human consumption. 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. ^{1 4 5 6 7}

Research Team

Celine Heskey, DrPH

Principal Investigator

Loma Linda University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Mango (Cancer Vaccine)

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mango supplementation improves blood glucose in obese individuals. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mangosteen Extract Shows a Potent Insulin Sensitizing Effect in Obese Female Patients: A Prospective Randomized Controlled Pilot Study. [2018]

3. England 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. [2017]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Antidiabetic properties of mango in animal models and humans: A systematic review. [2023]

6. Ireland 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. [2021]

7. Canada 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. [2022]