Cardiovascular Risk FactorNCT03203187
The Effect of Daily Mango Intake on Cardiovascular Health
A study testing Mango in people with Cardiovascular Risk Factor, 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 and short-term effects of mango intake on vascular and platelet function 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
- Cardiovascular Risk Factor
- What is being tested?
- Mango
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2016to 14 Sep 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, ½ glass of wine, and 1 shot of hard liquor)
- Fruit consumption ≥ 2 cups/day
Show all 29Show 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Regal Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: The Effect of Daily Mango Intake (Mangifera Indica L.) on Cardiovascular Health
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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Mango, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MangoOther
330 grams (2 cups) of daily mango intake for two weeks, one cup in the morning, the other in the evening
No interventionOther
No mango intake for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| No mango intake | Placebo comparator | No mango intake for two weeks Receives: Other: No intervention |
| 330 grams of daily mango intake | Experimental | 330 grams (2 cups) of daily mango intake for two weeks Receives: Other: Mango |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute vascular function
Comparison of the effect of mango on acute vascular function between baseline and 2-hour postprandial response using PAT.
Measured: change from baseline to 2 hours compared on days 0 14 and 28
Long-term vascular function
The effect of mango on long-term vascular function between baseline, two week, and four week time points using PAT
Measured: Comparison of day 0, 14, and 28
Secondary outcomes (2)
Acute platelet aggregation
Comparison of the effect of mango on acute platelet aggregation between baseline and 2-hour postprandial time.
Measured: change from baseline to 2 hours compared on days 0 14 and 28
Long-term platelet aggregation
Comparison of the effect of mango on long-term platelet aggregation baseline, two week, and four week time points.
Measured: Comparison of day 0, 14, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start2 Oct 2016
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203187
- Sponsor's protocol ID
- 894860
- Status last verified
- Sep 2022
- First submitted
- 27 Feb 2017
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Mango Intake (Mangifera Indica L.) on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT03203187
- Acronym / sponsor ID
- 894860
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 2 Oct 2016 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 29 Jun 2017 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No mango intake | Placebo comparator | Other: No interventionNo mango intake for two weeks |
| 330 grams of daily mango intake | Experimental | Other: Mango330 grams (2 cups) of daily mango intake for two weeks |
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 (29 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, ½ 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 |
|---|---|---|
| Mango330 grams (2 cups) of daily mango intake for two weeks, one cup in the morning, the other in the evening | Other | 330 grams of daily mango intake |
| No interventionNo mango intake for two weeks. | Other | No mango intake |
Primary outcome
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.
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
2 secondary outcomes
Acute platelet aggregation
Time frame: change from baseline to 2 hours compared on days 0 14 and 28
Long-term platelet aggregation
Time frame: Comparison of day 0, 14, and 28
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 2 Sep 2022.
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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 Mango in people with Cardiovascular Risk Factor, 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 29 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 2 Sep 2022. 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?
Acute vascular function (time frame: change from baseline to 2 hours compared on days 0 14 and 28). The study lists 2 primary outcomes in all. 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 2 Sep 2022.