Tart Cherry Supplementation and Women's Bone Health Study
キーワード
概要
説明
Tart cherries are an excellent course of phenolic compounds and anthocyanins, and in pre-clinical studies have been shown to prevent age-related bone loss. Based on these findings, this pilot study was designed to investigate the effects of three months of tart cherry juice supplementation on improving markers of oxidative stress and bone metabolism in older women. Women (n=30), aged 65-80 yrs, will be recruited for the study and randomly assigned to one of two doses of tart cherry juice (8 or 16 fl oz) per day prepared from a Montmorency cherry concentrate (King Orchards, Central Lake, MI). Study participants will complete two study visits to the Nutritional Sciences Clinical Research Center. At the first visit, informed consent will be obtained and relevant medical history and anthropometric measures will be taken by the research team. A blood draw will be performed to assess baseline, biochemical markers of bone metabolism and inflammation as well as indicators of oxidative status. A physical activity and food frequency questionnaire will be completed by each study participant. Whole body, hip and spine bone density (DXA) scan will be performed by certified bone densitometrist. A 3-month final visit will be scheduled for all study participants in which most of the procedures described at baseline (except DXA) will be repeated. Change in primary and secondary outcome measures (i.e., bone, inflammation and oxidative stress biomarkers) will be assessed.
日付
| 最終確認済み: | 10/31/2019 |
| 最初に提出された: | 11/09/2019 |
| 提出された推定登録数: | 11/14/2019 |
| 最初の投稿: | 11/17/2019 |
| 最終更新が送信されました: | 11/14/2019 |
| 最終更新日: | 11/17/2019 |
| 実際の研究開始日: | 06/05/2017 |
| 一次完了予定日: | 05/30/2018 |
| 研究完了予定日: | 05/30/2018 |
状態または病気
介入/治療
Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: Dose 1 Participants consume 8 fl oz of tart cherry juice per day. | |
| Experimental: Dose 2 Participants consume 2 x 8 fl oz of tart cherry juice per day. |
適格基準
| 研究の対象となる年齢 | 65 Years に 65 Years |
| 研究に適格な性別 | Female |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Women, 65-80 years of age - Capacity to give informed consent Exclusion Criteria: - Hormone replacement therapy in the 3 months prior to starting the study - Bisphosphonates in the 3 months prior to starting the study - Raloxifene in the 3 months prior to starting the study - Intermittent parathyroid hormone in the 3 months prior to starting the study - Growth hormone or steroids in the 3 months prior to starting the study - Osteoporosis - Renal disease - Cancer - Cardiovascular disease - Diabetes - Respiratory disease - Gastrointestinal diseases - Liver disease - Other chronic conditions that could affect bone metabolism |
結果
主な結果の測定
1. Bone-specific alkaline phosphatase (U/L) [Change from baseline to final visits (3 month intervention)]
2. Tartrate resistant acid phosphatase (U/L) [Change from baseline to final visits (3 month intervention)]
二次的な結果の測定
1. C-reactive protein (mg/L) [Change from baseline to final visits (3 month intervention)]
2. Thiobarbituric acid reactive species (TBARS) (U/L) [Change from baseline to final visits (3 month intervention)]
