Mango Consumption for Satiety

Overseen By Mee Young Hong

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Smoker, Pregnant, Dietary supplements, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating fresh mango pulp can help people feel fuller and improve certain health measures in those who are overweight or obese. Participants will consume either mango or low-fat cookies daily for 12 weeks to compare effects. Ideal candidates are adults with a BMI of 27 to 40 who do not smoke or have allergies to mango or gluten. The study aims to determine if mango can be a tasty way to manage weight and health. As an unphased trial, it offers a unique opportunity to explore natural dietary options for weight management.

Do I need to stop taking my current medications for the trial?

The trial requires that you do not need any medication for metabolic disorders, so if you are taking such medications, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that eating fresh mango pulp is likely safe. Studies suggest that mangos might help with issues like blood sugar and inflammation, which relate to being overweight. These studies have reported no major health problems from eating mangos, indicating they are generally well-tolerated. However, any new treatment can carry risks, so consulting a healthcare provider before joining a clinical trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike standard options for managing satiety, which often include high-fiber foods or appetite suppressant drugs, the treatment using fresh mango pulp is unique because it leverages the natural properties of mangoes to potentially enhance feelings of fullness. Mangoes are rich in dietary fiber and bioactive compounds, which can aid digestion and help control hunger in a natural way. Researchers are excited about this treatment because it offers a delicious, whole-food alternative that might improve satiety without the use of processed foods or pharmaceuticals. Plus, it could provide additional health benefits, like vitamins and antioxidants, making it a holistic option for those looking to manage their appetite.

What evidence suggests that this trial's treatments could be effective for satiety?

Research has shown that eating fresh mango can increase feelings of fullness and reduce hunger. This trial will compare the effects of consuming fresh mango with low-fat cookies. Participants in the mango fruit group will consume 100 kcal of mango daily for 12 weeks. Studies have found that fresh mango helps control blood sugar levels more effectively than dried mango and low-fat cookies. Eating fresh mango has been linked to better blood sugar and insulin control after meals. These findings suggest that fresh mango could help manage appetite and improve health in overweight or obese adults. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 with a BMI between 27 and 40, who are not pregnant, do not smoke, don't need dietary supplements or medications for metabolic disorders, and have no allergies to mango or gluten.

Inclusion Criteria

Your body mass index (BMI) is between 27 and 40.

Exclusion Criteria

Pregnant woman

I am on medication for a metabolic disorder.

Required dietary supplement use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 100 kcal of either mango fruit or low fat cookies daily

12 weeks

Regular visits for outcome measures at baseline, week 4, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fresh Mango Pulp Consumption

Trial Overview The study aims to see if eating fresh mango pulp affects how full people feel and their heart health-related numbers compared to having a low-fat cookie. Participants will be given either the fruit or the cookie in this research.

How Is the Trial Designed?

Group I: Mango fruit Experimental Treatment 1 Intervention

Subjects consume 100 kcal of mango fruit daily for 12 weeks.

Group II: Low fat cookies Active Control 1 Intervention

Subjects consume 100 kcal of low fat cookies daily for 12 weeks.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Published Research Related to This Trial

An aqueous extract of mango pulp (Mangifera indica cv. Azúcar) significantly inhibited the growth of human colon cancer cells (SW480) by 22.3% after 72 hours at a concentration of 200 µg/mL, indicating its potential as an antiproliferative agent.

In a rodent model, mango pulp in drinking water reduced the formation of precancerous lesions by over 60% in mice treated with a carcinogen, demonstrating its preventive capacity against colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[In vitro and in vivo effects of mango pulp (Mangifera indica cv. Azucar) in colon carcinogenesis]. Corrales-Bernal, A., Amparo Urango, L., Rojano, B., et al.[2016]

In a study with 23 overweight and obese participants, consuming 100 kcal of fresh mangos resulted in a significantly lower insulin response compared to isocaloric low-fat cookies, indicating better metabolic control after eating mangos.

Mango consumption also led to greater feelings of fullness and reduced hunger compared to cookies, suggesting that mangos may be more effective in promoting satiety and managing food intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh Mango Consumption Promotes Greater Satiety and Improves Postprandial Glucose and Insulin Responses in Healthy Overweight and Obese Adults. Pinneo, S., O'Mealy, C., Rosas, M., et al.[2022]

The report emphasizes the importance of thorough risk assessment strategies for food products with functional health benefits, highlighting the need for detailed product specifications, documented history of use, and intended exposure to ensure safety.

It also notes that the safety margin for these functional ingredients may be lower than for traditional food additives, necessitating careful evaluation of potential hazards and monitoring post-launch to confirm safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements. Schilter, B., Andersson, C., Anton, R., et al.[2019]

In a study involving 34 healthy adults, fresh mango consumption led to greater feelings of fullness and reduced desire to eat compared to dried mango and white bread, indicating its potential benefits for satiety.

Fresh mango also resulted in more effective control of postprandial glucose levels, showing a significant decrease in blood sugar compared to dried mango and white bread, which could be particularly beneficial for individuals managing weight or type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of fresh vs dried mango consumption on satiety and postprandial glucose in healthy adults. Stamper, C., Safadi, S., Gehr, A., et al.[2023]

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 study evaluated five mango varieties from four countries over a year, revealing that Ataulfo mangoes have significantly higher levels of phenolic antioxidants, specifically mangiferin and ellagic acid, compared to other varieties.

Total phenolic content and antioxidant capacity varied among the mango varieties, with values ranging from 19.5 to 166.7 mg of gallic acid equivalents per 100 g of puree, indicating that certain mango types may offer greater health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influences of harvest date and location on the levels of beta-carotene, ascorbic acid, total phenols, the in vitro antioxidant capacity, and phenolic profiles of five commercial varieties of mango (Mangifera indica L.). Manthey, JA., Perkins-Veazie, P.[2013]

Consuming whole apples significantly reduces energy intake at subsequent meals by 15% compared to no preload and is more effective than applesauce or apple juice, indicating that solid fruit enhances satiety more than processed forms.

The study involved 58 adults over 5 weeks, showing that whole fruit leads to greater fullness ratings than applesauce or juice, and adding fiber to juice does not improve satiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of fruit in different forms on energy intake and satiety at a meal. Flood-Obbagy, JE., Rolls, BJ.[2021]

The dried aerial parts of Hoodia parviflora are considered safe for use as a novel food ingredient in energy-reduced and sugar-free products, with no safety concerns raised by the EFSA Panel based on the provided data.

The maximum safe intake level for Hoodia parviflora as a food supplement is set at 9.4 mg per day for adults, while higher intake levels, particularly in elderly individuals, may exceed safety thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97. Turck, D., Bresson, JL., Burlingame, B., et al.[2023]

The approach to food risk analysis has evolved from aiming for zero risk to incorporating a balance of risk and benefit, reflecting a shift in how food safety is managed, especially regarding food additives and contaminants.

Quantitative risk-benefit analysis for functional foods remains challenging due to a lack of adequate tools and data, but concepts like substantial equivalence and disability adjusted life years (DALYs) are being explored to improve assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety impact--the risk/benefits of functional foods. Pascal, G.[2021]

A refined exposure assessment showed that the estimated daily intake (EDI) of synthetic food colors in the U.S. population, including children and adults, is well below the acceptable daily intake (ADI) levels set by health authorities, indicating safety in current usage.

The analysis confirmed that reported usage levels of food color additives align with FDA measurements, suggesting that the current practices of using these additives in food products do not pose a risk of excessive exposure to consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimated daily intake and safety of FD&C food-colour additives in the US population. Bastaki, M., Farrell, T., Bhusari, S., et al.[2018]

The study estimated the theoretical maximum daily intake of Sunset Yellow (SY) food dye in the Brazilian population, finding that average consumption did not exceed the acceptable daily intake (ADI) of 4.0 mg/kg body weight for most groups.

However, certain demographics, particularly adolescents and individuals in specific urban and rural areas, may consume levels of SY that approach or exceed the ADI, potentially posing health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimate of the theoretical maximum daily intake of Sunset Yellow FCF by the Brazilian population. Feitosa, LCA., Rodrigues, PDS., Da Silva, AS., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03957928?tab=table

Effects of Fresh Mango Pulp Consumption on Satiety and ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10374964/

Effects of fresh vs dried mango consumption on satiety and ... Consumption of fresh mango results showed a significant increase in satiety (tendency of greater fullness (P = 0.073) and less desire to eat (P < 0.05)) in ...

3. withpower.com withpower.com/trial/phase-2-2019-1b232

Mango Consumption for Satiety Fresh mango also resulted in more effective control of postprandial glucose levels, showing a significant decrease in blood sugar compared to dried mango and ...

4. clinicaltrial.be clinicaltrial.be/en/details/63569?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Effects of Fresh Mango Pulp Consumption on Satiety and ... The objective of the study is to determine the effects of fresh mango pulp consumption on satiety and metabolic parameters in overweight/obese ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34813369/

Fresh Mango Consumption Promotes Greater Satiety and ... Mango consumption promotes greater satiety, reduces hunger, and improves postprandial glucose and insulin responses compared to low-fat cookies.

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. liebertpub.com liebertpub.com/doi/10.1089/jmf.2021.0063

Fresh Mango Consumption Promotes Greater Satiety and ... These results suggest that relative to a refined cookie snack, mangos promote greater satiety and improve postprandial glycemic responses.