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NCT05785884 · ClinicalTrials.gov registry record · NA

Diet Interventions: Remitted and Evaluated as Complementary Treatments for Pain

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

Recruiting
Registry status
NA
Development phase
200
Enrollment target
1
Study location

NCT05785884 is a NA study of Knee Osteoarthritis that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 200 participants, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05785884, a NA study of Knee Osteoarthritis, is actively recruiting participants, sponsored by University of Alabama at Birmingham.

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
1
Study location

Study Summary

Knee osteoarthritis (OA) is the most prevalent form of arthritis, a significant cause of disability in the U.S. With an aging population and the rise in obesity rates, the prevalence of knee OA is expected to climb, significantly reducing quality of life (QOL) for those suffering from this debilitating condition. Current national efforts to reduce analgesic utilization highlight the critical need for safe, effective, and accessible alternatives for pain relief. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological complementary treatment. However, differences exist in metabolism that are rarely addressed in diet intervention studies. Thus, it is important to assess the potential of different diets in a broad population of chronic pain sufferers to determine the potential of diets to reduce knee OA pain. We have shown that a LCD was associated with reduced evoked knee OA pain, daily pain and oxidative stress when compared to either a USDA diet or a diet-as-usual control. Both experimental diets reduced weight to a similar degree, arguing that diet quality was likely the key factor in pain reduction, as opposed to weight loss. However, previous studies comparing diets have utilized diet prescriptions with less control for adherence to the diets. To overcome this obstacle, and in line with our recent work, we will provide all snacks and meals during the diet intervention to increase adherence and retention in the study, allowing for better control over diet interventions and consistency of foods within each study group. We will recruit adults with knee OA (N=200) to complete our two-phase protocol. Phase 1 will involve a 1-week diet run-up that will allow for quantification of pain measures, psychosocial variables (socioeconomic status, nutritional knowledge, proximity to grocery stores, food insecurity), and diet quality to provide a baseline for comparison. Phase 2 will be

Conditions Studied

Interventions

  • BEHAVIORAL Diet

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2023-02-01
Est. Completion 2027-06-30
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT05785884

The ClinicalTrials.gov registry entry for NCT05785884 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (34% 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 Diet is the first listed.

NCT05785884 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT05785884 about?

NCT05785884 is a clinical study titled "Diet Interventions: Remitted and Evaluated as Complementary Treatments for Pain". Knee osteoarthritis (OA) is the most prevalent form of arthritis, a significant cause of disability in the U.S. With an aging population and the rise in obesity rates, the prevalence of knee OA is expected to climb, significantly reducing quality of life (QOL) for those suffering from this debilitat...

What is the current status of trial NCT05785884?

This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-02-01. Estimated completion is 2027-06-30.

What conditions does trial NCT05785884 study?

This clinical trial studies the following conditions: Knee Osteoarthritis.

What interventions are being tested in trial NCT05785884?

The interventions under investigation include: Diet (BEHAVIORAL).

Who is sponsoring clinical trial NCT05785884?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05785884 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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