NCT06828159

Brief Summary

The goal of this proposed study is to examine the effects of dietary wild blueberries on gut microbiome, serum markers of inflammation, and joint function in adults. Each participant will consume 25g freeze-dried blueberries or matched placebo powder for 12 weeks, with a 2-week washout phase between.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Mar 2028

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

November 5, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

February 10, 2025

Last Update Submit

November 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum biomarkers of joint function

    Serum biomarkers of inflammation and cartilage degradation will be measured in the wild blueberry and placebo groups and compared for outcomes. Pain scores will also be measured using self-reported questionnaires.

    12 weeks

Secondary Outcomes (1)

  • Gut microbiome

    12 weeks

Study Arms (2)

Wild blueberries

EXPERIMENTAL

25g freeze-dried wild blueberries daily for 12 weeks

Dietary Supplement: Wild blueberry

Placebo

PLACEBO COMPARATOR

Placebo powder free from polyphenols matched for calories

Dietary Supplement: Placebo

Interventions

Wild blueberryDIETARY_SUPPLEMENT

Freeze-dried wild blueberry powder 25g/day

Wild blueberries
PlaceboDIETARY_SUPPLEMENT

Placebo powder matched for calories and no polyphenols

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with documented multi-joint/knee arthritis

You may not qualify if:

  • inability to give informed consent
  • pregnancy or lactation
  • planned knee replacement surgery
  • allergy or contraindication to berries
  • recent trauma of the knee responsible of the symptomatic knee
  • intra-articular injection in the target knee/hip in the last 3 months
  • oral corticosteroid therapy ≥ 5 mg/day (prednisone equivalent) at baseline
  • use of berry extracts in the last 3 months
  • special diets
  • cancer treatment
  • bone diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OMRF

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

November 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations