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Can a Low-Carb diet ease knee pain? a study investigates racial differences

NCT ID NCT04343716

Symptom relief Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests whether a low-carbohydrate diet (under 40 grams of carbs per day) can reduce pain and improve quality of life in women aged 65-75 with knee osteoarthritis. It specifically looks at whether the diet's effects differ between African-American and non-Hispanic white women. Participants follow the diet for 6 weeks, with meals provided, and researchers measure pain, function, mood, and blood markers of oxidative stress. The goal is to see if this dietary approach could be a personalized way to manage knee OA pain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-carbohydrate diet (less than 40 grams of carbs per day) provided as prepared meals
What this could lead to
If successful, this could show that a low-carb diet is a useful, non-drug way to reduce knee osteoarthritis pain, and that its benefits may vary by race, leading to more personalized dietary recommendations.
What could go wrong
This is a small, early study with only 19 participants, so results may not apply to everyone. The diet is restrictive and may be hard to follow, and any pain relief might not be due to the diet alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

19 people

The number who actually took part.

Started

Oct 2020

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. diagnosis of knee OA 2. pain in at least 4/7 days/week for the past 3 months 3. age between 65-75 4. average daily consumption of \>100 g carbohydrates 5. understanding of verbal and written English 6. self-identification as either AA or NHW 7. BMI between 25 and 40 kg/m2 Exclusion Criteria: 1. diabetes 2. unwillingness to follow prescribed diets 3. recent weight change (\>4 kg in past month) 4. currently on a diet 5. history of eating disorders or other psychiatric disorders 6. digestive diseases 7. difficulty chewing or swallowing 8. reliance on others for meal preparation 9. cardiovascular or pulmonary disease 10. daily opioid pain medications 11. use of medications known to alter metabolism or digestion (e.g., proton-pump inhibitors) 12. use of anti-hypertensive medications that affect glucose tolerance 13. use of tobacco 14. participation in extreme exercise 15. knee replacement

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Conditions

The condition(s) this trial relates to.

Chronic Pain osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee osteoarthritis

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.