Mango Cardiometabolic Study

Investigators are looking for men and women between 40-60 years of age with prediabetes (HbA1C: 5.7-6.4%) and with excess adiposity (either a waist circumference >102 cm for men or >88 cm for women or a BMI between 25 to 39 kg/m2). Participants should be able to commute to Loma Linda University, Loma Linda, California.

If you have any of the following criteria you will not qualify for this study:

1. Intolerance or allergy to mangos or latex
2. Regular intake of mangos (greater than 3 servings per week) and/or other fruit (greater than 2 servings/day)
3. Smoking, use of tobacco, or alcohol intake (greater than 2 drinks/day for men or 1 drink per day for women)
4. Recent significant weight loss of greater than 5% within the last 6 months
5. A body mass index (BMI) greater than 39 kg/m2
6. Pregnancy or breastfeeding
7. Having a chronic disease (diabetes, heart disease, cancer, kidney disease, inflammatory bowel disease, or similar) or relevant psychiatric illness, including major depression
8. Use of medications or supplements that can affect blood glucose or lipids
9. Use of a pacemaker
10. Not having access to a computer or tablet with internet access.
11. Not able to read and/or communicate in English

If a participant has any of these criteria, he/she will not be included in the study.

After the pre-randomization visit, participants must be willing to commit for a total duration of up to 32 weeks and to attend office visits. During this time, participants are expected to attend all scheduled meetings and visits. Participants must be equally willing to consume mangos or abstain from mangos and limit other fruit, while continuing their usual diet and other routines or lifestyle habits.

Participants will be randomized to 12 weeks of mango (1.5 servings per day) followed by 12 weeks off of mango following a 4 to 8 week break, or vice versa. Mangos will be available for pick up every 2 weeks.

Participants are expected to visit the clinic 8 times during the study (about once a month). Body composition measurements which means measuring your weight, body fat mass and muscle mass using an InBody machine will be done at each of the clinic visits (8 total) by a trained clinician. During three of these visits participants will be fasting (this means that you must have nothing to eat and drink except water after 8 p.m. the evening before) to provide blood samples. About 3 tablespoons of blood will be collected during the blood draw visits.

You can let us know if you are interested in the study by any of the following 2 ways:

1. Send us an email to mangostudy@llu.edu
2. Call us at 909-558-8382 from 9am to 3pm

Please let us know the days and the time you will be available to take calls.

The study will last for up to 32 weeks (approximately 7 months) from start to finish.

There is NO cost to the participants for any of the study-associated intervention or tests.

The committee at Loma Linda University that reviews human studies (Institutional Review Board) has determined that participating in this study could expose you to minimal risk. Some of the foreseeable risks or discomforts of your participation include discomfort, bruising or bleeding from the A1C (finger prick) test and blood draw, and potential allergic reaction to the mangos. There  is a risk of breach of confidentiality. This risk will be minimized by deindentifying your research record, and keeping records protected by encryption, passwords, and/or in locked offices. Only authorized personnel will have access to the study data.

You may or may not benefit from this study. However, it is hoped that the information learned from this study will benefit other people in the future.

You will be provided with the results of your diet assessment and a variety of tests at the completion of the study. These results will provide information that may pertain to your health, and if there are any abnormalities detected, we recommend that you follow-up with your primary care provider.

You will be paid a total of $200 in the form of gift cards over the course of this study. Upon your completion of the first blood draw clinic (week 0) you will receive $25; upon completion of the second blood draw clinic (week 12) you will receive $50; and upon completion of the third blood draw clinic (end of study) you will receive $125.

Participation in this study is voluntary. Your decision on whether to participate in or withdraw at any time from the study will not affect your ongoing medical care or relationship to your doctors and will not involve any penalty or loss of benefits to which you are otherwise entitled.

Dates will be provided soon.