Blood PressureNCT04057495
The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose
A study testing further fasting, white bread consumption and mango consumption in people with Blood Pressure, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- further fasting, white bread consumption and mango consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Regal Human Nutrition Research Center
Davis, California, 95616
About this study
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.
Read the detailed description
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.
Polyphenolic 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.
- Conditions
- Blood Pressure
- Being tested
- further fasting, white bread consumption, mango consumption
- Keywords
- Blood glucose, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
further fastingOther
2 hours of fasting
white bread consumptionOther
113 grams of white bread consumption
mango consumptionOther
330 grams of mango consumption
| Study group | Role | What they receive |
|---|---|---|
| no mango intake | Placebo comparator | No mango consumption on the study visit Receives: Other: further fasting |
| white bread with same amount of calorie as mango | Experimental | White bread consumption on the study visit Receives: Other: white bread consumption |
| mango consumption | Experimental | mango consumption on the study visit Receives: Other: mango consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 hours
Secondary outcomes (2)
Change in blood glucose
Changes in blood glucose from baseline to two hours following fasting or consumption of white bread or mango.
Measured: Baseline, 2 hours
Change in insulin levels
Changes in insulin from baseline to two hours following fasting or consumption of white bread or mango.
Measured: Baseline, 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start11 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Mango Board, USDA Beltsville Human Nutrition Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057495
- Sponsor's protocol ID
- 1453713
- Status last verified
- Jul 2021
- First submitted
- 13 Aug 2019
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Mango Intake (Mangifera Indica L.) on Blood Pressure and Blood Glucose
- ClinicalTrials.gov ID
- NCT04057495
- Acronym / sponsor ID
- 1453713
- Conditions
- Blood Pressure
- Keywords
- Blood glucose, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Mango Board, USDA Beltsville Human Nutrition Research Center
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Polyphenolic 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no mango intake | Placebo comparator | Other: further fastingNo mango consumption on the study visit |
| white bread with same amount of calorie as mango | Experimental | Other: white bread consumptionWhite bread consumption on the study visit |
| mango consumption | Experimental | Other: mango consumptionmango consumption on the study visit |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| further fasting2 hours of fasting | Other | no mango intake |
| white bread consumption113 grams of white bread consumption | Other | white bread with same amount of calorie as mango |
| mango consumption330 grams of mango consumption | Other | mango consumption |
Primary outcome
Change in blood pressure
Time frame: Baseline, 2 hours
Changes in measures of blood pressure (mmHg) from baseline to two hours following fasting or consumption of white bread or mango.
2 secondary outcomes
Change in blood glucose
Time frame: Baseline, 2 hours
Change in insulin levels
Time frame: Baseline, 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing further fasting, white bread consumption and mango consumption in people with Blood Pressure, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Baseline, 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.