Blood Pressure Clinical Trial
Official title:
The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose
| NCT number | NCT04057495 |
| Other study ID # | 1453713 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 11, 2019 |
| Est. completion date | April 1, 2020 |
| Verified date | July 2021 |
| Source | University of California, Davis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | April 1, 2020 |
| Est. primary completion date | March 1, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 50 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Regal Human Nutrition Research Center | Davis | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Davis | National Mango Board, USDA Beltsville Human Nutrition Research Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in blood pressure | Changes in measures of blood pressure (mmHg) from baseline to two hours following fasting or consumption of white bread or mango. | Baseline, 2 hours | |
| Secondary | Change in blood glucose | Changes in blood glucose from baseline to two hours following fasting or consumption of white bread or mango. | Baseline, 2 hours | |
| Secondary | Change in insulin levels | Changes in insulin from baseline to two hours following fasting or consumption of white bread or mango. | Baseline, 2 hours |
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