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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: Completed NA study of Knee Osteoarthritis, sponsored by University of Alabama at Birmingham.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score is a 0-20 score with higher scores reflecting more severe pain. Questions 1-5 are summed to provide a WOMAC pain score. Change scores will be calculated. The week 6 WOMAC pain subscale score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change.

Conditions Studied

Interventions

  • BEHAVIORAL Low-carbohydrate diet

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2020-10-01
Est. Completion 2023-09-18
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT04343716 record still lists

NCT04343716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

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.

Where NCT04343716's enrollment target sits among peer trials

19 93rd of 101 higher than 8 of 101 other Knee Osteoarthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Knee Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04343716, the US trial registry maintained by the National Library of Medicine. NCT04343716 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.