The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2019
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedStudy Start
First participant enrolled
November 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJuly 23, 2021
July 1, 2021
4 months
August 13, 2019
July 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in blood glucose
Baseline, 2 hours
Change in insulin levels
Baseline, 2 hours
Study Arms (3)
no mango intake
PLACEBO COMPARATORNo mango consumption on the study visit
white bread with same amount of calorie as mango
EXPERIMENTALWhite bread consumption on the study visit
mango consumption
EXPERIMENTALmango consumption on the study visit
Interventions
113 grams of white bread consumption
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- National Mango Boardcollaborator
- USDA Beltsville Human Nutrition Research Centercollaborator
Study Sites (1)
Regal Human Nutrition Research Center
Davis, California, 95616, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2019
First Posted
August 15, 2019
Study Start
November 11, 2019
Primary Completion
March 1, 2020
Study Completion
April 1, 2020
Last Updated
July 23, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share