Mangos to Reduce Cardiometabolic Risk Markers

Healthy Clinical Trial

Official title:

Mangos to Reduce Cardiometabolic Risk Markers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06029647
• Other study ID #: 603036
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: California State Polytechnic University, Pomona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cardiovascular disease (CVD) is the leading cause of death in the United States and worldwide. Risk factors for CVD include, obesity, high serum concentrations of low-density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides, and total cholesterol, as well as low serum concentrations of high-density lipoprotein (HDL) cholesterol. Hypertension (high blood pressure) is an additional risk factor for CVD. Dietary strategies to reduce the risk for CVD include consuming adequate amounts of fruits, vegetables, and whole grains. However, there is limited published research regarding the effects of specific food items on CVD risk factors. One such example are mangos; there are murine studies, but there is a paucity of human clinical trial research on the effects of mango consumption on decreasing the risk factors for CVD. Therefore, the objective of this proposed study will examine whether mango consumption lowers these CVD risk factors in individuals with hypertension and/or dyslipidemia. The hypothesis is that mango consumption will decrease LDL-cholesterol, VLDL-cholesterol, triglycerides, total cholesterol, body weight, and blood pressure, and increase HDL-cholesterol. This proposed study will follow a randomized, controlled, cross-over design. Blood draws will be performed at baseline, after 8 weeks, and at the end of each dietary treatment, at the Student Health Services at California State Polytechnic University, Pomona. In addition, height, body weight, and blood pressure measurements will be taken. Subsequently, lipid panels will be generated for each participant, and those with dyslipidemia and/or hypertension will consume either 1 cup of mango or vanilla wafers (iso-caloric control) per day for 16 weeks. After a 4-week washout period, the subjects will consume the other dietary treatment for 16 weeks. Two-way repeated measures Analysis of Variance (ANOVA), followed by least significant difference (LSD) post-hoc analysis, will be used to determine if there are significant differences in CVD risk factors between the mango and wafer diets. Furthermore, the participants will complete two 24-hour recalls during the week before each laboratory visit. It is expected that the consumption of mangos will decrease LDL-cholesterol, VLDL-cholesterol, triglycerides, total cholesterol, body weight, and blood pressure, and increase HDL-cholesterol compared to the wafer diet. This proposed study will be the first to determine the cardiovascular health benefits of mango consumption in humans.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Mango
The participants will consume the treatment for 16 weeks, followed by a 4-week washout period.
• vanilla wafers
vanilla wafers

Locations

Country	Name	City	State
United States	California State Polytechnic University, Pomona	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
California State Polytechnic University, Pomona

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2021 Jun 26;397(10293):2466. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body weight (kg) and height (cm)	Body weight, height, and body mass index (BMI) will be measured.	16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
Secondary	Blood lipids (mg/dL)	Total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides will be measured.	16 weeks for mango consumption and 16 weeks for vanilla wafer consumption
Secondary	Dietary analysis (six 24-hour dietary recalls per person in each treatment arm)	Dietary nutrient consumption will be measured (g or mg).	16 weeks for mango consumption and 16 weeks for vanilla wafer consumption