Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Cerebral Blood Flow and Cognitive Function
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|ClinicalTrials.gov Identifier: NCT02381860|
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Decline||Other: Placebo Dietary Supplement: 60mL tart Montmorency cherry juice||Not Applicable|
Each participant will be required to attend the laboratory on three occasions. The first of these will be an initial screening/training visit, within 14 days of the first active study visit. During the initial visit participants will be provided with written informed consent and screened with regards the study exclusion/inclusion criteria. Training will be given on the cognitive tasks and familiarisation with the study procedures will be provided.
Study days: Forty - eight hours prior to each study day, participants will begin dietary restrictions. Participants will then attend the first study day following an overnight fast. A cannula will be inserted and baseline blood samples obtained, baseline measures of cerebral blood flow will be examined using near infrared spectroscopy and its effect on cognitive function using a cognitive demand battery. The relevant drink will then be provided and blood samples and blood flow measures will be taken at hourly intervals (1, 2, 3, and 5h). No additional food or drink will be provided during the study period except for low-nitrate mineral water. After a minimum of 2 weeks, participants will be asked to return to the lab and repeat the procedure with the other drink.
Cerebral oxygenation will be assessed using near - infrared spectroscopy . Two near-infrared sensors will be placed on the skin over the right and left prefrontal cortex region of the forehead, and the signals were averaged to determine cerebral oxygenation. The sensors will be secured to the skin using double-sided adhesive tape and shielded from ambient light using an elastic bandage. The sensors alternately emit near-infrared light at wavelengths of 730 and 810 nm. Each sensor contains two detectors located at 3 and 4 cm from the emitting source that detect oxygenated and deoxygenated states of Hb to estimate regional O2 saturation based on internal algorithms (Rasmussen et al. 2007).
Blood velocity in the middle cerebral artery (MCAV) will be determined using transcranial Doppler sonography. A 2 MHz Doppler probe was positioned over the right middle cerebral artery using previously described search techniques (Aaslid et al. 1982) and will be secured with an adjustable headset (DiaMon, Compumedics DWL). The mean depth for Doppler signals was 51 ± 3 mm. Arterial blood pressure will be recorded with a transducer located at heart level (TruWave, Edwards Lifesciences, Nyon, Switzerland).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Cerebral Blood Flow and Cognitive Function|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Placebo Comparator: Placebo
The PLA supplement consisted of a commercially available, less than 5% fruit, cordial (Protein - Trace, Carbohydrate 260 mg•mL−1, Sodium 0.02 mg•mL−1, Fibre-Trace and Anthocyanins-Trace for colour), mixed with water, whey protein isolate (Arla Foods Ltd., Leeds, UK) and maltodextrin (MyProtein Ltd., Northwich, UK) until matched for carbohydrate and calorie content of the MC.
One bolus of less than 5% fruit cordial mixed with water, maltodextrin and whey protein isolate to match for carbohydrate and calorie content of the juice.
Other Name: less than 5% "Kia Ora" mixed fruit squash
Active Comparator: 60mL of cherry concentrate with 100ml water
One bolus of 60mL of tart Montmorency cherry (MC) juice mixed with 100mL of water. Independent analysis of MC (Atlas Biosciences, 2010) provided the following compositional data; Fat 0.028 mg•mL−1, Protein 31.47 mg•mL−1, Carbohydrate 669.4 mg•mL−1, Cholesterol < 0.01 mg•mL−1, Sodium 0.691 mg•mL−1, Calcium 0.137 mg•mL−1 and Iron 0.026 mg•mL−1. Additionally, according to the manufacturers guidelines (Cherry Active, Hanworth, UK),
Dietary Supplement: 60mL tart Montmorency cherry juice
One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.
- Changes in Cerebral Blood Flow [ Time Frame: 0,1,2,3, and 5 hours ]
- Changes in Cognitive Function [ Time Frame: 0,1,2,3 and 5 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381860
|Newcastle, United Kingdom, NE18ST|