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Mango for Prediabetes
N/A
Recruiting
Led By Celine Heskey, DrPH
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Abdominal obesity as defined as a waist circumference >102 cm for men or >88 cm for women
Be between 18 and 65 years old
Must not have
Not able to read and/or communicate in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up fasting blood glucose and insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the effect of eating 1.5 cups of mango per day for 12 weeks on indicators of glycemia, insulin resistance, lipids, inflammation, oxidation and body composition in people with prediabetes.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from consuming mangos may include digestive issues like bloating or gas due to increased fiber intake; however specific side effects related to this intervention have not been detailed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My waist is over 102 cm if I am a man, or over 88 cm if I am a woman.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot read or communicate in English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ fasting blood glucose and insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fasting blood glucose and insulin will be measured in fasting blood that will be drawn at weeks 0 and 12 of the first phase and the last week of the second phase of the study.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
HOMA-IR (Insulin resistance)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mango added to habitual dietExperimental Treatment1 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 mangoActive Control1 Intervention
Participants will be asked to refrain consuming mangos for 12 weeks while continuing their habitual diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mango
2022
Completed Phase 1
~290
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
316 Previous Clinical Trials
266,669 Total Patients Enrolled
National Mango BoardOTHER
6 Previous Clinical Trials
270 Total Patients Enrolled
Celine Heskey, DrPHPrincipal InvestigatorLoma Linda University
1 Previous Clinical Trials
59 Total Patients Enrolled
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