Knee OsteoarthritisNCT05784545
Dietary Supplementation With Blueberry in OA
A study testing Blueberry powder supplement and Maltodextrin supplementation in people with Knee Osteoarthritis, run by University of Exeter at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Blueberry powder supplement and Maltodextrin supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon University Hospital
Honiton, Devon, EX14 9AJ
About this study
Official title: Highbush Blueberry Supplementation for Osteoarthritis Pain, Intra-articular Inflammation and Post-operative Recovery in Total Knee Replacement Patients
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
- Being tested
- Blueberry powder supplement, Maltodextrin supplementation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry powder supplementDietary 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 supplementationDietary supplement
The intervention in this study is 12 weeks of daily maltodextrin supplement used to mimic the carbohydrate composition of whole blueberries.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin supplementation |
| Blueberry Supplementation | Experimental | Not described Receives: Dietary Supplement: Blueberry powder supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of TNF-ALPHA gene expression in joint tissue (synovium, infrapatellar adipose tissue and cartilage)
Inflammatory protein
Measured: In knee at time of surgery (when replaced)
Secondary outcomes (3)
Concentration of broad panel of Inflammatory and pro-cartilage cytokines samples
Using multiplex immunoassay including but not limited to at TNFα, IL-6, IL-10 and IL-1β, MIP1α, Galectin 1, Chemerin, Eotaxin, gp130, MCP-1, IL-7, MIP3α, IL-15, Aggrecan, Resistin, Leptin, MIP1β, MMP-1, MMP-3 and MMP-13
Measured: Baseline and pre-operatively
Concentration of broad panel of Inflammatory and pro-cartilage degradative gene and protein expression markers
Using RTqPCR and immunoblotting including but not limited to TNFα, IL-6, IL1β, 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
Measured: In knee at time of surgery (when replaced)
Western Ontario and McMaster Universities Arthritis Index Score
Validated questionnaire (0-96 where a higher score is worse)
Measured: Baseline, week 3, week 6, post-surgery, weeks 7, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start22 May 2023
- Primary completion1 Feb 2025
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council, Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784545
- Sponsor's protocol ID
- IRAS Number: 318841
- Status last verified
- Apr 2025
- First submitted
- 1 Mar 2023
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highbush Blueberry Supplementation for Osteoarthritis Pain, Intra-articular Inflammation and Post-operative Recovery in Total Knee Replacement Patients
- ClinicalTrials.gov ID
- NCT05784545
- Acronym / sponsor ID
- IRAS Number: 318841
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council, Royal Devon and Exeter NHS Foundation Trust
- Study start
- 22 May 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin supplementation |
| Blueberry Supplementation | Experimental | Dietary Supplement: Blueberry powder supplement |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry powder supplementThe 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. | Dietary supplement | Blueberry Supplementation |
| Maltodextrin supplementationThe intervention in this study is 12 weeks of daily maltodextrin supplement used to mimic the carbohydrate composition of whole blueberries. | Dietary supplement | Placebo |
Primary outcome
Concentration of TNF-ALPHA gene expression in joint tissue (synovium, infrapatellar adipose tissue and cartilage)
Time frame: In knee at time of surgery (when replaced)
Inflammatory protein
3 secondary outcomes
Concentration of broad panel of Inflammatory and pro-cartilage cytokines samples
Time frame: Baseline and pre-operatively
Concentration of broad panel of Inflammatory and pro-cartilage degradative gene and protein expression markers
Time frame: In knee at time of surgery (when replaced)
Western Ontario and McMaster Universities Arthritis Index Score
Time frame: Baseline, week 3, week 6, post-surgery, weeks 7, 9 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry powder supplement and Maltodextrin supplementation in people with Knee Osteoarthritis, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of TNF-ALPHA gene expression in joint tissue (synovium, infrapatellar adipose tissue and cartilage) (time frame: In knee at time of surgery (when replaced)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.