The Effect of Daily Mango Intake on Cardiovascular Health
Schlüsselwörter
Abstrakt
Termine
Zuletzt überprüft: | 05/31/2020 |
Zuerst eingereicht: | 02/26/2017 |
Geschätzte Einschreibung eingereicht: | 06/26/2017 |
Zuerst veröffentlicht: | 06/28/2017 |
Letztes eingereichtes Update: | 06/10/2020 |
Letztes Update veröffentlicht: | 06/11/2020 |
Tatsächliches Startdatum der Studie: | 10/01/2016 |
Geschätztes primäres Abschlussdatum: | 07/13/2026 |
Voraussichtliches Abschlussdatum der Studie: | 08/13/2026 |
Zustand oder Krankheit
Intervention / Behandlung
Other: 330 grams of daily mango intake
Other: No mango intake
Phase
Armgruppen
Arm | Intervention / Behandlung |
---|---|
Placebo Comparator: No mango intake No mango intake for two weeks | Other: No mango intake No mango intake for two weeks. |
Experimental: 330 grams of daily mango intake 330 grams (2 cups) of daily mango intake for two weeks | Other: 330 grams of daily mango intake 330 grams (2 cups) of daily mango intake for two weeks, one cup in the morning, the other in the evening |
Zulassungskriterien
Altersberechtigt für das Studium | 50 Years Zu 50 Years |
Studienberechtigte Geschlechter | Female |
Akzeptiert gesunde Freiwillige | Ja |
Kriterien | 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, 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 - 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. |
Ergebnis
Primäre Ergebnismaße
1. Acute vascular function [change from baseline to 2 hours compared on days 0 14 and 28]
2. Long-term vascular function [Comparison of day 0, 14, and 28]
Sekundäre Ergebnismaße
1. Acute platelet aggregation [change from baseline to 2 hours compared on days 0 14 and 28]
2. Long-term platelet aggregation [Comparison of day 0, 14, and 28]