Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04343716 · ClinicalTrials.gov registry record · NA
Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis
A NA study of Knee Osteoarthritis, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04343716 is a NA study of Knee Osteoarthritis that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 19 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04343716, a NA study of Knee Osteoarthritis, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Knee osteoarthritis (OA) is the most prevalent form of arthritis and race is a risk factor for poor outcomes. African-Americans (AAs) report greater OA-related disability and pain severity compared to their Non-Hispanic White (NHW) counterparts. These disparities are reinforced through social and biological mechanisms, ultimately resulting in dramatic racial disparities in pain experience and associated quality of life. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, but significant racial differences exist in metabolism that are rarely addressed in diet interventions. The overall objective of the proposed study is to determine whether the beneficial effects of an LCD for knee OA pain are related to race. The investigators will recruit 20 adult women (65-75) with knee OA with equal representation across racial groups (10 AA, 10 NHW). Following one week of diet and pain self-report, the investigators will assess quality of life, depression, experienced pain and evoked pain. Participants will be placed on a LCD wherein all meals and snacks will be delivered weekly after consult with study personnel. Participants will return every 3 weeks for testing during the 6-week intervention with blood drawn at baseline and at the conclusion of the 6-week diet. Blood will be assayed for oxidative stress markers. This will be the first assessment of racial differences in the efficacy of a LCD to reduce knee OA pain. Objective 1: To determine whether the LCD reduces pain after 6 weeks. Hypothesis: The LCD will significantly reduce evoked and self-reported pain. Objective 2: To determine whether the benefits of the LCD differ based on race. Hypothesis 1: The LCD will reduce evoked and self-reported pain more in AA than in NHW. Hypothesis 2: AAs will experience greater improvements in depression, quality of life, pain interference and show more weight loss than NHWs. Objective 3: To determine whether the LCD has a differential impact on oxid
Conditions Studied
Interventions
- BEHAVIORAL Low-carbohydrate diet
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2023-09-18 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04343716
The ClinicalTrials.gov registry entry for NCT04343716 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (94% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Low-carbohydrate diet is the first listed.
NCT04343716 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT04343716 about?
NCT04343716 is a clinical study titled "Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis". Knee osteoarthritis (OA) is the most prevalent form of arthritis and race is a risk factor for poor outcomes. African-Americans (AAs) report greater OA-related disability and pain severity compared to their Non-Hispanic White (NHW) counterparts. These disparities are reinforced through social and bi...
What is the current status of trial NCT04343716?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2020-10-01. Estimated completion is 2023-09-18.
What conditions does trial NCT04343716 study?
This clinical trial studies the following conditions: Knee Osteoarthritis.
What interventions are being tested in trial NCT04343716?
The interventions under investigation include: Low-carbohydrate diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT04343716?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04343716 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Knee Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
RECRUITING · NA
-
Focused Extracorporeal Shockwave Therapy for Knee Arthritis
RECRUITING · NA
-
Mechanical Alignment Vs Kalipered Kinematic Alignment Total Knee Arthroplasty
RECRUITING · NA
-
Investigating Patient Satisfaction With Smart Knee Implants
RECRUITING · NA
-
Gait Rehabilitation to Treat FastOA
RECRUITING · NA
-
Knee Biofeedback Rehabilitation Through Game Therapy
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.