Tart Cherry Supplementation and Women's Bone Health Study
Mots clés
Abstrait
La description
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.
Rendez-vous
| Dernière vérification: | 10/31/2019 |
| Première soumission: | 11/09/2019 |
| Inscription estimée soumise: | 11/14/2019 |
| Première publication: | 11/17/2019 |
| Dernière mise à jour soumise: | 11/14/2019 |
| Dernière mise à jour publiée: | 11/17/2019 |
| Date de début réelle de l'étude: | 06/05/2017 |
| Date d'achèvement primaire estimée: | 05/30/2018 |
| Date estimée d'achèvement de l'étude: | 05/30/2018 |
Condition ou maladie
Intervention / traitement
Dietary Supplement: tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| 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. |
Critère d'éligibilité
| Âges éligibles aux études | 65 Years À 65 Years |
| Sexes éligibles à l'étude | Female |
| Accepte les bénévoles en santé | Oui |
| Critères | 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 |
Résultat
Mesures des résultats primaires
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)]
Mesures des résultats secondaires
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)]
