ACTIVE_NOT_RECRUITING

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes: a Randomized Controlled Crossover Trial

Quick Facts

Study Start:2024-07-30
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06159543

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * HgbA1c of 5.7 to 6.4% indicative of prediabetes
  2. * Abdominal obesity as defined as a waist circumference \>102 cm for men or \>88 cm for women
  1. * Self-reported chronic disease history (diabetes, heart disease, cancer, kidney disease, inflammatory bowel disease, etc.)
  2. * Pacemaker
  3. * Mango allergies
  4. * Latex allergies (cross-reactive with mango)
  5. * Smoking, use of tobacco, or high alcohol intake (\>2 drinks/day for men or \>1 drink per day for women)
  6. * Recent significant weight loss (\>5% within 6 months of study enrollment)
  7. * BMI \>35 kg/m\^2
  8. * Pregnancy or lactation
  9. * Use of medication and/or supplements affecting glycemic indicators or lipids
  10. * Habitual mango intake of \>3 servings per week and/or habitual fruit intake of \>2 servings per day
  11. * Not able to read and/or communicate in English

Contacts and Locations

Principal Investigator

Celine Heskey, DrPH
PRINCIPAL_INVESTIGATOR
Loma Linda University

Study Locations (Sites)

Nutrition Research Center, School of Public Health, Loma Linda University
Loma Linda, California, 92350
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Celine Heskey, DrPH, PRINCIPAL_INVESTIGATOR, Loma Linda University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-30
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-07-30
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Hyperglycemia
  • Dyslipidemias
  • Insulin Resistance
  • Inflammation
  • Oxidative Stress