Effects of Cranberry Juice on Cardiovascular Risk Factors
キーワード
概要
説明
The investigators propose to conduct a 2-period randomized, crossover, placebo-controlled study to evaluate the effect of cranberry juice on central and peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics, and HDL function. Eligibility requires non-smoking men and women to be 30 to 65 years of age with BMI greater than or equal to 18 and less than or equal to 39, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, triglycerides below 350 mg/dL, and have systolic blood pressure of 120 to 159 mmHg and/or diastolic blood pressure of 80 to 99 mmHg. Subjects will undergo randomized treatments including 500 mL/d cranberry juice beverage and 500 mL/d of a color and taste matched placebo beverage. The two 8 to 12 week treatment periods will be separated by an 8 week washout.
日付
| 最終確認済み: | 11/30/2019 |
| 最初に提出された: | 09/17/2015 |
| 提出された推定登録数: | 09/20/2015 |
| 最初の投稿: | 09/21/2015 |
| 最終更新が送信されました: | 12/11/2019 |
| 最終更新日: | 12/12/2019 |
| 実際の研究開始日: | 09/30/2015 |
| 一次完了予定日: | 04/30/2019 |
| 研究完了予定日: | 04/30/2019 |
状態または病気
介入/治療
Dietary Supplement: Cranberry Juice Beverage
Dietary Supplement: Placebo Beverage
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Cranberry Juice Beverage 16 ounces of 54% cranberry juice cocktail | Dietary Supplement: Cranberry Juice Beverage 16 ounces of 54% cranberry juice cocktail |
| Placebo Comparator: Placebo Beverage Color, calorie, and taste matched beverage without cranberry bioactives | Dietary Supplement: Placebo Beverage Color, calorie, and taste matched beverage without cranberry bioactives |
適格基準
| 研究の対象となる年齢 | 30 Years に 30 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Men and women 30-65 years of age 2. BMI ≥ 18 and ≤ 39 kg/m^2 3. Total cholesterol below 273 mg/dL for men and below 284 mg/dL for women 4. Triglycerides below 350 mg/dL 5. Non-smokers 6. At least one of the following: 1. Systolic blood pressure 120-159 mmHg 2. Diastolic blood pressure 80-99 mmHg Exclusion Criteria: 1. History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within previous 6 months are provided) 2. History of diabetes mellitus (and/or a fasting glucose >126 mg/dL at screening) 3. Stage II hypertension (blood pressure ≥ 160/100 mmHg) 4. Lactation, pregnancy, or desire to become pregnant during the study 5. Unwillingness to discontinue nutritional supplements, herbs, or vitamins unless approved by investigator 6. Use of medications/supplements for elevated lipids, blood pressure, or glucose 7. Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication 8. Conditions requiring the use of steroids 9. Unwillingness to refrain from blood donation prior to and during the study 10. Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator 11. Allergy or sensitivity to cranberry juice or any ingredient in the study beverages |
結果
主な結果の測定
1. Central Blood Pressure [Change from baseline after 8 week treatments with cranberry and placebo]
2. Peripheral Blood Pressure [Change from baseline after 8 week treatments with cranberry and placebo]
二次的な結果の測定
1. Efflux capacity of HDL [Change from baseline after 8 week treatments with cranberry and placebo]
2. Augmentation Index [Change from baseline after 8 week treatments with cranberry and placebo]
3. Pulse Wave Velocity [Change from baseline after 8 week treatments with cranberry and placebo]
4. LDL-C [Change from baseline after 8 week treatments with cranberry and placebo]
5. LDL Particle Size [Change from baseline after 8 week treatments with cranberry and placebo]
6. Total Cholesterol [Change from baseline after 8 week treatments with cranberry and placebo]
7. Triglycerides [Change from baseline after 8 week treatments with cranberry and placebo]
8. HDL-C [Change from baseline after 8 week treatments with cranberry and placebo]
9. Oxidized LDL (oxLDL) [Change from baseline after 8 week treatments with cranberry and placebo]
10. Malondialdehyde (MDA) [Change from baseline after 8 week treatments with cranberry and placebo]
11. High Sensitivity C Reactive Protein (hs-CRP) [Change from baseline after 8 week treatments with cranberry and placebo]
12. 24-hr Ambulatory Blood Pressure [Change from baseline after 8 week treatments with cranberry and placebo]
