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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057495
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborators:
National Mango Board
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
University of California, Davis

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057495


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

Locations
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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

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04057495    
Other Study ID Numbers: 1453713
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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