The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose

• ClinicalTrials.gov Identifier: NCT04057495
• Recruitment Status: Recruiting
• First Posted: August 15, 2019
• Last Update Posted: November 22, 2019
• Sponsor: University of California, Davis
• Collaborators: National Mango Board; USDA Beltsville Human Nutrition Research Center
• Information provided by (Responsible Party): University of California, Davis

Study Description

Brief Summary:

In the current proposal the investigators seek to evaluate the acute effects of mango intake on blood pressure, blood glucose and insulin in postmenopausal women between 50 and 70 years old.

Condition or disease	Intervention/treatment	Phase
Blood Pressure	Other: further fasting; Other: white bread consumption; Other: mango consumption	Not Applicable

Detailed Description:

Cardiovascular disease (CVD) is the leading cause of mortality in the U.S, and aging is the largest risk factor for vascular diseases. Both male and female adults have increased risk for CVD as they age. For postmenopausal women, this risk is particularly elevated due to the loss of the protective effect of estrogen. It is evident that nutrition plays a crucial role in prevention of chronic diseases such as heart disease, stroke and cancer. Scientific evidence shows that high intake of plant-based food lowers the risk of CVD and many other chronic diseases.

Polyphenolic compounds in fruits and nuts have been the focus of extensive research regarding their potential to reduce risk for a number of chronic diseases. However, fruits and nuts vary largely in the type and amounts of phytonutrients they provide. Mango (Mangifera Idica L.), a commonly cultivated fruit worldwide, is rich in polyphenolic compounds such as gallic acid, mangiferin, quercetin glycosides, ferulic acid, and hydroxybenzoic acid. Many of those bioactive compounds have been found to have anti-diabetic and anti-inflammatory effects in cell models. For instance, mangiferin has been proved to effectively reducing glucose-induced endoplasmic reticulum stress by inhibiting IREα phosphorylation and ROS production in endothelial cells. However, it is unknown if the phytonutrients in mango will demonstrate a similar impact in humans. Therefore, the overall objective of this study is to investigate the effects of acute mango intake on blood pressure and blood glucose.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose
• Actual Study Start Date: November 11, 2019
• Estimated Primary Completion Date: June 1, 2020
• Estimated Study Completion Date: July 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: no mango intake; No mango consumption on the study visit	Other: further fasting; 2 hours of fasting
Experimental: white bread with same amount of calorie as mango; White bread consumption on the study visit	Other: white bread consumption; 113 grams of white bread consumption
Experimental: mango consumption; mango consumption on the study visit	Other: mango consumption; 330 grams of mango consumption

Outcome Measures

Primary Outcome Measures :

1. Change in blood pressure [ Time Frame: Baseline, 2 hours ]
   Changes in measures of blood pressure (mmHg) from baseline to two hours following fasting or consumption of white bread or mango.

Secondary Outcome Measures :

1. Change in blood glucose [ Time Frame: Baseline, 2 hours ]
   Changes in blood glucose from baseline to two hours following fasting or consumption of white bread or mango.
2. Change in insulin levels [ Time Frame: Baseline, 2 hours ]
   Changes in insulin from baseline to two hours following fasting or consumption of white bread or mango.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Postmenopausal female: 50-70 years
• Women: lack of menses for at least one year and FSH 23-116.3 mlU/mL
• Subject is willing and able to comply with the study protocols.
• Subject is willing participate in all study procedures
• BMI 25.0 - 40 kg/m2
• Weight ≥ 110 pounds

Exclusion Criteria:

• BMI ≥ 40 kg/m2
• Dislike or allergy for mango
• Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
• Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
• Alcohol consumption > 3 drinks/week (i.e. 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)
• Fruit consumption ≥ 2 cups/day
• Vegetable consumption ≥ 3 cups/day for females
• Fatty Fish ≥ 3 times/week
• Coffee/tea ≥ 3 cups/day
• Dark chocolate ≥ 3 oz/day
• Self-reported restriction of physical activity due to a chronic health condition
• Self-reported chronic/routine high intensity exercise
• Self-reported diabetes
• Blood pressure ≥ 140/90 mm Hg
• Self-reported renal or liver disease
• Self-reported heart disease, which includes cardiovascular events and Stroke
• Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
• Self-reported cancer within past 5 years
• Self-reported malabsorption

Contacts and Locations

Contacts

Contact: Robert Hackman, PhD; 5309790417; rmhackman@ucdavis.edu

Locations

United States, California

Regal Human Nutrition Research Center; Recruiting

Davis, California, United States, 95616

Contact: Xiang Li 530-761-8971 xxlli@ucdavis.edu

Sponsors and Collaborators

University of California, Davis

National Mango Board

USDA Beltsville Human Nutrition Research Center

More Information

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04057495
• Other Study ID Numbers: 1453713
• First Posted: August 15, 2019
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:

Blood glucose; Insulin