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Can cutting carbs curb knee pain? a diet trial puts it to the test

NCT ID NCT05785884

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study investigates whether a low-carbohydrate diet can reduce pain and improve quality of life in adults with knee osteoarthritis, compared to a standard USDA-recommended diet. Participants will follow a 6-week diet plan with all meals provided, and researchers will measure changes in pain, physical function, and mood. The goal is to see if diet quality, rather than weight loss alone, can offer a non-drug approach to managing knee pain.

What this could mean

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

Active substance
A 6-week randomized diet intervention comparing a low-carbohydrate diet (LCD) to a USDA-recommended diet, with all meals provided.
What this could lead to
If successful, this could establish a low-carbohydrate diet as a safe, non-drug way to reduce knee osteoarthritis pain and improve quality of life.
What could go wrong
The trial is relatively small and short-term, and results may not apply to everyone. Adherence to the diet is key, and individual responses may vary.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

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

40 to 75 years

Sex

Anyone

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 (pain of ≥3/10 on 0-10 scale) 3. age between 40-75 4. average daily consumption of \>100 g carbohydrates (based on Phase 1 food checklist) 5. understanding of verbal and written English 6. self-identification as either NHB or NHW 7. BMI between 25 and 40 kg/m2 Exclusion Criteria: 1. unmedicated 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 requiring hospitalization within the past 6 months 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.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

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