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The Effect of Daily Mango Intake on Cardiovascular Health

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203187
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Other: Mango Other: No intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Daily Mango Intake (Mangifera Indica L.) on Cardiovascular Health
Actual Study Start Date : October 2, 2016
Actual Primary Completion Date : September 14, 2020
Actual Study Completion Date : September 14, 2020

Arm Intervention/treatment
Placebo Comparator: No mango intake
No mango intake for two weeks
Other: No intervention
No mango intake for two weeks.

Experimental: 330 grams of daily mango intake
330 grams (2 cups) of daily mango intake for two weeks
Other: Mango
330 grams (2 cups) of daily mango intake for two weeks, one cup in the morning, the other in the evening




Primary Outcome Measures :
  1. Acute vascular function [ Time Frame: change from baseline to 2 hours compared on days 0 14 and 28 ]
    Comparison of the effect of mango on acute vascular function between baseline and 2-hour postprandial response using PAT.

  2. Long-term vascular function [ Time Frame: Comparison of day 0, 14, and 28 ]
    The effect of mango on long-term vascular function between baseline, two week, and four week time points using PAT


Secondary Outcome Measures :
  1. Acute platelet aggregation [ Time Frame: change from baseline to 2 hours compared on days 0 14 and 28 ]
    Comparison of the effect of mango on acute platelet aggregation between baseline and 2-hour postprandial time.

  2. Long-term platelet aggregation [ Time Frame: Comparison of day 0, 14, and 28 ]
    Comparison of the effect of mango on long-term platelet aggregation baseline, two week, and four week time points.



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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, 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.

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): NCT03203187


Locations
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United States, California
Regal Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03203187    
Other Study ID Numbers: 894860
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: September 2022

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