The Effect of Daily Mango Intake on Cardiovascular Health

Study Overview
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Brief Summary
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In the current proposal the investigators seek to evaluate the acute and short-term effects of mango intake on vascular and platelet function in postmenopausal women between 50 and 70 years old. Our aims are 1) to determine if two weeks of daily mango intake will result in favorable changes in measures of vascular function, as measured using peripheral arterial tonometry (PAT) and platelet reactivity, in overweight and obese postmenopausal women. 2) to determine if two weeks of daily mango intake will change the fermentation capacity of gut microbiota. Investigators hypothesize that the daily intake of 330 grams of mango (2 cups) will significantly increase PAT while reducing platelet aggregation after 2 hours and two weeks of daily intake.

Official Title
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The Effect of Daily Mango Intake (Mangifera Indica L.) on Cardiovascular Health

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Mango
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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, ½ 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 Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT 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 Currently taking prescription drugs or supplements, other than thyroid medication. Use of multi-vitamin and mineral other than a general formula of vitamins and minerals that meet the RDA Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment. Indications of substance or alcohol abuse within the last 3 years Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL]. Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL]. (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp); Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp). Current enrollee in a clinical research study.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No mango intake<br>No mango intake for two weeks | Other: No intervention<br>* No mango intake for two weeks.<br>|
| Experimental: 330 grams of daily mango intake<br>330 grams (2 cups) of daily mango intake for two weeks | Other: Mango<br>* 330 grams (2 cups) of daily mango intake for two weeks, one cup in the morning, the other in the evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute vascular function | Comparison of the effect of mango on acute vascular function between baseline and 2-hour postprandial response using PAT. | change from baseline to 2 hours compared on days 0 14 and 28 | 
| Long-term vascular function | The effect of mango on long-term vascular function between baseline, two week, and four week time points using PAT | Comparison of day 0, 14, and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute platelet aggregation | Comparison of the effect of mango on acute platelet aggregation between baseline and 2-hour postprandial time. | change from baseline to 2 hours compared on days 0 14 and 28 | 
| Long-term platelet aggregation | Comparison of the effect of mango on long-term platelet aggregation baseline, two week, and four week time points. | Comparison of day 0, 14, and 28 |