Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT04057495
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2019-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, 2 hours', 'description': 'Changes in measures of blood pressure (mmHg) from baseline to two hours following fasting or consumption of white bread or mango.'}], 'secondaryOutcomes': [{'measure': 'Change in blood glucose', 'timeFrame': 'Baseline, 2 hours', 'description': 'Changes in blood glucose from baseline to two hours following fasting or consumption of white bread or mango.'}, {'measure': 'Change in insulin levels', 'timeFrame': 'Baseline, 2 hours', 'description': 'Changes in insulin from baseline to two hours following fasting or consumption of white bread or mango.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood glucose', 'Insulin'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPolyphenolic 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal female: 50-70 years\n* Women: lack of menses for at least one year and FSH 23-116.3 mlU/mL\n* Subject is willing and able to comply with the study protocols.\n* Subject is willing participate in all study procedures\n* BMI 25.0 - 40 kg/m2\n* Weight ≥ 110 pounds\n\nExclusion Criteria:\n\n* BMI ≥ 40 kg/m2\n* Dislike or allergy for mango\n* Self-reported use of daily anticoagulation agents including aspirin, NSAIDs\n* Vegan, Vegetarians, food faddists or those consuming a non-traditional diet\n* Alcohol consumption \\> 3 drinks/week (i.e. 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)\n* Fruit consumption ≥ 2 cups/day\n* Vegetable consumption ≥ 3 cups/day for females\n* Fatty Fish ≥ 3 times/week\n* Coffee/tea ≥ 3 cups/day\n* Dark chocolate ≥ 3 oz/day\n* Self-reported restriction of physical activity due to a chronic health condition\n* Self-reported chronic/routine high intensity exercise\n* Self-reported diabetes\n* Blood pressure ≥ 140/90 mm Hg\n* Self-reported renal or liver disease\n* Self-reported heart disease, which includes cardiovascular events and Stroke\n* Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.\n* Self-reported cancer within past 5 years\n* Self-reported malabsorption'}, 'identificationModule': {'nctId': 'NCT04057495', 'briefTitle': 'The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose', 'orgStudyIdInfo': {'id': '1453713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'no mango intake', 'description': 'No mango consumption on the study visit', 'interventionNames': ['Other: further fasting']}, {'type': 'EXPERIMENTAL', 'label': 'white bread with same amount of calorie as mango', 'description': 'White bread consumption on the study visit', 'interventionNames': ['Other: white bread consumption']}, {'type': 'EXPERIMENTAL', 'label': 'mango consumption', 'description': 'mango consumption on the study visit', 'interventionNames': ['Other: mango consumption']}], 'interventions': [{'name': 'further fasting', 'type': 'OTHER', 'description': '2 hours of fasting', 'armGroupLabels': ['no mango intake']}, {'name': 'white bread consumption', 'type': 'OTHER', 'description': '113 grams of white bread consumption', 'armGroupLabels': ['white bread with same amount of calorie as mango']}, {'name': 'mango consumption', 'type': 'OTHER', 'description': '330 grams of mango consumption', 'armGroupLabels': ['mango consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Regal Human Nutrition Research Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Mango Board', 'class': 'OTHER'}, {'name': 'USDA Beltsville Human Nutrition Research Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}