Mangos to Reduce Cardiometabolic Risk Markers

NCT06029647 | Completed

• 1 other identifier: 603036
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will determine the effects of mango consumption on blood pressure, body weight, dietary nutrient/pattern changes, total cholesterol, LDL-cholesterol, VLDL-cholesterol, triglycerides, and HDL-cholesterol in individuals with moderately elevated blood pressure and/or LDL-cholesterol.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Blood pressure (mm Hg)

  Systolic and diastolic blood pressure will be measured.

  16 weeks for mango consumption and 16 weeks for vanilla wafer consumption

Secondary Outcomes (3)

• Body weight (kg) and height (cm)

  16 weeks for mango consumption and 16 weeks for vanilla wafer consumption

• Blood lipids (mg/dL)

  16 weeks for mango consumption and 16 weeks for vanilla wafer consumption

• Dietary analysis (six 24-hour dietary recalls per person in each treatment arm)

  16 weeks for mango consumption and 16 weeks for vanilla wafer consumption

Study Arms (2)

Mango

EXPERIMENTAL

The participants will consume one cup of fresh mango (100 kcal) per day for sixteen weeks.

Other: Mango

Wafer

PLACEBO COMPARATOR

The participants will consume vanilla wafers (100 kcal) per day for sixteen weeks.

Other: vanilla wafers

Interventions

Mango OTHER

The participants will consume the treatment for 16 weeks, followed by a 4-week washout period.

Mango

vanilla wafers OTHER

vanilla wafers

Wafer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy students (18 to 40 years)
• Attend California State Polytechnic University, Pomona
• Moderately elevated blood pressure (systolic greater than 120 mm Hg or diastolic greater than 80 mm Hg) and/or LDL-cholesterol (greater than 100 mg/dL)

You may not qualify if:

• Smokers
• Pregnancy
• Any medical issues
• Allergies or dislike of mangos
• Allergies to wheat, milk, eggs, and/or soy

Sponsors & Collaborators

• California State Polytechnic University, Pomona: lead

Study Sites (1)

California State Polytechnic University, Pomona

Pomona, California, 91768, United States

Location

Related Publications (9)

• GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.

  PMID: 30954305 BACKGROUND

• Lee-Kwan SH, Moore LV, Blanck HM, Harris DM, Galuska D. Disparities in State-Specific Adult Fruit and Vegetable Consumption - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Nov 17;66(45):1241-1247. doi: 10.15585/mmwr.mm6645a1.

  PMID: 29145355 BACKGROUND

• Gorinstein S, Zemser M, Haruenkit R, Chuthakorn R, Grauer F, Martin-Belloso O, Trakhtenberg S. Comparative content of total polyphenols and dietary fiber in tropical fruits and persimmon. J Nutr Biochem. 1999 Jun;10(6):367-71. doi: 10.1016/s0955-2863(99)00017-0.

  PMID: 15539312 BACKGROUND

• Papanikolaou Y, Fulgoni VL 3rd. Mango Consumption Is Associated with Improved Nutrient Intakes, Diet Quality, and Weight-Related Health Outcomes. Nutrients. 2021 Dec 24;14(1):59. doi: 10.3390/nu14010059.

  PMID: 35010933 BACKGROUND

• Arshad F, Umbreen H, Aslam I, Hameed A, Aftab K, Al-Qahtani WH, Aslam N, Noreen R. Therapeutic Role of Mango Peels in Management of Dyslipidemia and Oxidative Stress in Obese Females. Biomed Res Int. 2021 Oct 23;2021:3094571. doi: 10.1155/2021/3094571. eCollection 2021.

  PMID: 34725636 BACKGROUND

• Evans SF, Beebe M, Mahmood M, Janthachotikun S, Eldoumi H, Peterson S, Payton M, Perkins-Veazie P, Smith BJ, Lucas EA. Mango Supplementation Has No Effects on Inflammatory Mediators in Obese Adults. Nutr Metab Insights. 2017 Sep 25;10:1178638817731770. doi: 10.1177/1178638817731770. eCollection 2017.

  PMID: 28983188 BACKGROUND

• O'Hara C, Ojo B, Emerson SR, Simenson AJ, Peterson S, Perkins-Veazie P, Payton ME, Hermann J, Smith BJ, Lucas EA. Acute Freeze-Dried Mango Consumption With a High-Fat Meal has Minimal Effects on Postprandial Metabolism, Inflammation and Antioxidant Enzymes. Nutr Metab Insights. 2019 Aug 19;12:1178638819869946. doi: 10.1177/1178638819869946. eCollection 2019.

  PMID: 31452602 BACKGROUND

• Rosas M Jr, Pinneo S, O'Mealy C, Tsang M, Liu C, Kern M, Hooshmand S, Hong MY. Effects of fresh mango consumption on cardiometabolic risk factors in overweight and obese adults. Nutr Metab Cardiovasc Dis. 2022 Feb;32(2):494-503. doi: 10.1016/j.numecd.2021.11.001. Epub 2021 Nov 12.

  PMID: 34953634 BACKGROUND

• Ross SM. African mango (IGOB131): a proprietary seed extract of Irvingia gabonensis is found to be effective in reducing body weight and improving metabolic parameters in overweight humans. Holist Nurs Pract. 2011 Jul-Aug;25(4):215-7. doi: 10.1097/HNP.0b013e318222735a. No abstract available.

  PMID: 21697664 BACKGROUND

MeSH Terms

Interventions

Mangifera indica extract

Study Officials

• Erik Froyen, PhD

  Cal Poly Pomona

  PRINCIPAL INVESTIGATOR

• Bonny Burns-Whitmore, DrPH, RD

  Cal Poly Pomona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will follow a randomized, controlled, crossover design with two 16-week dietary interventions separated by 4-week washout periods.

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 8, 2023
• Study Start: September 18, 2023
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: February 13, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)