Dietary Supplementation With Blueberry in OA

Knee Osteoarthritis Clinical Trial

Official title:

Highbush Blueberry Supplementation for Osteoarthritis Pain, Intra-articular Inflammation and Post-operative Recovery in Total Knee Replacement Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784545
• Other study ID #: IRAS Number: 318841
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: September 2023
• Source: University of Exeter
• Contact: MARY OLEARY
• Phone: 01392 724759
• Email: m.oleary[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis is a painful long term joint condition that is associated with poor quality of life. There are no treatments to prevent it. Inflammation is one cause of osteoarthritis. This inflammation is complex. It involves many joint tissues, like cartilage and fat. It also involves many proteins that act as inflammatory 'signals'. Safely targeting these proteins with medications has so far proved ineffective. Physiotherapy and weight loss can help osteoarthritis, but there is a need for other approaches. Blueberries are rich in natural chemicals called polyphenols; these have well-established anti-inflammatory effects.

Blueberries and other fruits may improve osteoarthritis symptoms, but the investigators do not know how this improvement happens. It may be that these foods reduce inflammation within the joint tissues. They will investigate this. This will help us to understand 1) how blueberries improve osteoarthritis symptoms and 2) whether dietary supplementation with blueberries could slow down joint damage in osteoarthritis, rather than just improving symptoms. Additionally, high levels of joint inflammation predict poorer recovery from joint replacement surgery. Therefore, blueberry supplementation may hasten this recovery. Fifty eight people scheduled to have a knee replacement for osteoarthritis will receive either six weeks blueberry supplementation or a placebo pre-surgery. Participants will continue the supplementation for six weeks after surgery. First, this study will use tissue samples (cartilage, fat and the joint lining called synovium) obtained during surgery to investigate the effects of pre-operative blueberry supplementation on markers of joint inflammation. Second, this study will assess the ability of dietary supplementation with blueberries to improve the symptoms of osteoarthritis. Finally, this study will investigate the effect of blueberry supplementation on recovery from total knee replacement. Our investigations may provide evidence to support dietary supplementation with blueberries to slow down osteoarthritis progression and to improve recovery from osteoarthritis joint replacement surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: April 1, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Participants capable of giving informed consent

• Sex: Male and female

• Age: > 40 years - Those under 40 are more likely to have an undiagnosed secondary cause of osteoarthritis

• BMI: > 18 kg/m2

• Listed to have a total knee replacement for osteoarthritis

• Participants are permitted to participate in other ongoing surgical intervention studies, as long as these are not trials of a dietary supplement or a medication.

Exclusion Criteria:

• Those who have received intravenous or oral immunosuppressant medications in past 2 years

• Those who have had intra-articular steroid injection in 6 months preceding surgery.

• Some secondary causes of osteoarthritis (mechanistic confounders that are likely to influence tissue inflammation measures:

• Known congenital joint disorders

• Other inflammatory arthritis e.g. rheumatoid arthritis

• Avascular necrosis, infectious arthritis

• Paget disease

• Osteopetrosis

• Osteochondritis dissecans

• Hemochromatosis

• Wilson's disease

• Hemoglobinopathy

• Ehlers-Danlos syndrome

• Marfan syndrome

• Acromegaly

• Those typically consuming more than eight 80 g portions (or juice equivalent) of blueberries, blackberries, strawberries, raspberries, blackcurrants, pomegranate or cherries per week

• Those with a known fruit allergy, for which they carry an adrenaline auto-injector or have required anti-histamine, adrenaline, glucocorticoid or beta-agonist treatment.

• Those who cannot adequately understand verbal explanations or written information given in English

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis

Intervention

Dietary Supplement:
• Blueberry powder supplement
The intervention in this study is 12 weeks of daily blueberry supplementation which is comprised of freeze-dried powdered whole blueberries i.e., blueberries with water removed.
• Maltodextrin supplementation
The intervention in this study is 12 weeks of daily maltodextrin supplement used to mimic the carbohydrate composition of whole blueberries.

Locations

Country	Name	City	State
United Kingdom	Royal Devon University Hospital	Honiton	Devon

Sponsors (3)

Lead Sponsor	Collaborator
University of Exeter	Royal Devon University Healthcare NHS Foundation Trust, U.S. Highbush Blueberry Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of TNF-ALPHA gene expression in joint tissue (synovium, infrapatellar adipose tissue and cartilage)	Inflammatory protein	In knee at time of surgery (when replaced)
Secondary	Concentration of broad panel of Inflammatory and pro-cartilage cytokines samples	Using multiplex immunoassay including but not limited to at TNFa, IL-6, IL-10 and IL-1ß, MIP1a, Galectin 1, Chemerin, Eotaxin, gp130, MCP-1, IL-7, MIP3a, IL-15, Aggrecan, Resistin, Leptin, MIP1ß, MMP-1, MMP-3 and MMP-13	Baseline and pre-operatively
Secondary	Concentration of broad panel of Inflammatory and pro-cartilage degradative gene and protein expression markers	Using RTqPCR and immunoblotting including but not limited to TNFa, IL-6, IL1ß, IL-8, IL-10, IL-18, IL-7, IL-15, MCP1, LEP, ADIPOQ, NAMPT, RETN, TGFB1, MMP1, MMP2, MMP3, MMP9, MMP13, TIMP1, TIMP2, TIMP3, TIMP4, ADAMTS4, ADAMTS5, , ACAN, COL1A1, COL2A1, COL13A1, COL14A1, COL15A1, DKK1, CCL2, CCL3, CCL4, CCL5, CCL7, CCL8, CCL11, CCL20, CX3CL1, CCR3, CCR2, LGALS1, RARRES2, and IL6ST	In knee at time of surgery (when replaced)
Secondary	Western Ontario and McMaster Universities Arthritis Index Score	Validated questionnaire (0-96 where a higher score is worse)	Baseline, week 3, week 6, post-surgery, weeks 7, 9 and 12