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Dietary Interventions for Osteoarthritis Pain (DIRECTPain Trial)

N/A
Recruiting
Led By Robert E Sorge, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), immediately before the intervention (week 3), 3 weeks after initiating the intervention (week 6), immediately after the intervention (week 9)
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate the efficacy of low-carb diets to reduce knee OA pain, with an emphasis on racial differences and interactions with biopsychosocial factors. #OA #RacialDisparities #PainRelief #LCD

Who is the study for?
This trial is for English-speaking adults aged 40-75 with knee osteoarthritis, who self-identify as either Non-Hispanic Black or White, have a BMI of 25-40, eat more than 100g of carbs daily, and experience pain most days. Excluded are those on opioids or certain other meds, with recent weight change, major surgery like knee replacement, severe diseases affecting heart/lungs/digestion/metabolism, extreme exercisers or dieters.
What is being tested?
The study tests if a low-carbohydrate diet can reduce pain and improve quality of life in people with knee OA compared to the standard USDA diet. It will also look at how race might affect these outcomes by focusing on differences between Non-Hispanic Blacks and Whites.
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects from dietary changes may include digestive discomforts such as constipation or diarrhea due to shifts in fiber intake; fatigue during initial adjustment periods; and possible nutrient deficiencies if not properly managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), immediately before the intervention (week 3), 3 weeks after initiating the intervention (week 6), immediately after the intervention (week 9)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), immediately before the intervention (week 3), 3 weeks after initiating the intervention (week 6), immediately after the intervention (week 9) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BPI pain change
TUG pain intensity change
Western Ontario and McMaster Osteoarthritis Index pain change
Secondary study objectives
BPI pain interference change
PHQ-9 Depression change
Repeated Chair Stand pain intensity change
+3 more
Other study objectives
Repeated Chair Stand time to completion change
TBARS change
TUG time to completion change
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-Hispanic WhiteExperimental Treatment2 Interventions
White adults ages 40-75 with knee OA.
Group II: Non-Hispanic BlackExperimental Treatment2 Interventions
Black adults ages 40-75 with knee OA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-carbohydrate diet
2007
N/A
~160
USDA Diet
2018
N/A
~30

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,173 Total Patients Enrolled
8 Trials studying Osteoarthritis
44,432 Patients Enrolled for Osteoarthritis
Robert E Sorge, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Osteoarthritis
20 Patients Enrolled for Osteoarthritis

Media Library

Low-carbohydrate diet Clinical Trial Eligibility Overview. Trial Name: NCT05785884 — N/A
Osteoarthritis Clinical Trial 2023: Low-carbohydrate diet Highlights & Side Effects. Trial Name: NCT05785884 — N/A
Low-carbohydrate diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05785884 — N/A
Osteoarthritis Research Study Groups: Non-Hispanic Black, Non-Hispanic White
~115 spots leftby Jun 2027
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