Dietary Supplementation With Blueberry in OA

NCT05784545 | Active Not Recruiting

• 1 other identifier: IRAS Number: 318841
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Concentration of broad panel of Inflammatory and pro-cartilage cytokines samples

  Baseline and pre-operatively

• Concentration of broad panel of Inflammatory and pro-cartilage degradative gene and protein expression markers

  In knee at time of surgery (when replaced)

• Western Ontario and McMaster Universities Arthritis Index Score

  Baseline, week 3, week 6, post-surgery, weeks 7, 9 and 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Maltodextrin supplementation

Blueberry Supplementation

EXPERIMENTAL

Dietary Supplement: Blueberry powder supplement

Interventions

Blueberry powder supplement DIETARY_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.

Blueberry Supplementation

Maltodextrin supplementation DIETARY_SUPPLEMENT

The intervention in this study is 12 weeks of daily maltodextrin supplement used to mimic the carbohydrate composition of whole blueberries.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• U.S. Highbush Blueberry Council: collaborator
• Royal Devon and Exeter NHS Foundation Trust: collaborator

Study Sites (1)

Royal Devon University Hospital

Honiton, Devon, EX14 9AJ, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 27, 2023
• Study Start: May 22, 2023
• Primary Completion: February 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)