The Effect of Daily Mango Intake on Cardiovascular Health

NCT03203187 | Completed

• 1 other identifier: 894860
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Acute vascular function

  Comparison of the effect of mango on acute vascular function between baseline and 2-hour postprandial response using PAT.

  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

  Comparison of day 0, 14, and 28

Secondary Outcomes (2)

• Acute platelet aggregation

  change from baseline to 2 hours compared on days 0 14 and 28

• Long-term platelet aggregation

  Comparison of day 0, 14, and 28

Study Arms (2)

No mango intake

PLACEBO COMPARATOR

No mango intake for two weeks

Other: No intervention

330 grams of daily mango intake

EXPERIMENTAL

330 grams (2 cups) of daily mango intake for two weeks

Other: Mango

Interventions

Mango OTHER

330 grams (2 cups) of daily mango intake for two weeks, one cup in the morning, the other in the evening

330 grams of daily mango intake

No intervention OTHER

No mango intake for two weeks.

No mango intake

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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, ½ 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Regal Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

Mangifera indica extract

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: February 27, 2017
• First Posted: June 29, 2017
• Study Start: October 2, 2016
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

US (1)