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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03743519
Other study ID # Cherry juice
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2019
Est. completion date June 1, 2020

Study information

Verified date May 2019
Source University of Central Lancashire
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patellofemoral pain (PFP) is the most common chronic pathology in sports medicine and physiotherapy clinics. As pain and inflammation are the main symptoms of PFP, non-steroidal anti-inflammatory and analgesic medications are often utilized to decrease pain and inflammation; however alternative treatments are increasingly being sought due to the cardiovascular and gastrointestinal side effects of traditional pain medications. Most researchers advocate conservative treatment, though there is still insufficient clarity regarding the effectiveness of conservative treatment modalities. Dietary interventions for PFP have not received any attention in clinical literature, yet there is a growing body of evidence indicating that cherries have significant anti-inflammatory, antioxidant and pain-mediating effects.

Therefore, the primary purpose of the proposed investigation was to test (using a randomized control investigation) the ability of a tart cherry juice blend to provide symptom relief in recreational athletes with PFP and to understand the biological and mechanical mechanisms behind any changes in PFP symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 1, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Recreationally active

- Suffering from mild to moderate patellofemoral pain with no evidence of any other condition.

Exclusion Criteria:

- Rheumatoid arthritis or other systemic inflammatory condition

- Chronic pain syndrome

- Corticosteroid medication in last 2 months (intra-articular or oral)

- Intra-articular injections of hyaluronic acid in the last 9 months

- Pregnancy

- Diabetes

- Food allergies to cherries.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Cherry juice
30 mL of tart cherry juice concentrate, which will be diluted with 200 mL of water.
Placebo
Identical in taste and colour to the Cherry juice, but with no anthocyanin content

Locations

Country Name City State
United Kingdom University of Central Lancashire Preston Lancs

Sponsors (1)

Lead Sponsor Collaborator
University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee injury and Osteoarthritis Outcome Score (KOOS) - patellofemoral scale This is a questionnaire based measurement that allows participants to subjectively rate the extent of their patellofemoral pain symptoms. This measurement is scored on a 0-100 scale with 100 indicating no pain. 6-weeks
Secondary COOP-WONCA - psychological wellbeing This is a questionnaire based measurement that allows participants to subjectively rate their psychological wellbeing. This measurement provides a value that is an average score of 6 questions (overall health, daily activities, physical fitness, feelings, social activities and change in health) that range from 1-5. A lower score indicates better psychological wellbeing. 6-weeks
Secondary Plasma urate 6-weeks
Secondary Creatinine 6-weeks
Secondary human TNF-alpha 6-weeks
Secondary High sensitivity C-reactive protein 6-weeks
Secondary Pittsburgh Sleep Quality Index The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality. 6-weeks
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