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Effects of Acetyl L-Carnitine Supplementation on Clinical, Metabolic and Inflammatory Symptoms in Obese, Diabetic, Postmenopausal Women With Osteoarthritis
Plain-language guide to NCT07660081: not phased randomized trial of L-Carnitine, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07660081
- Phase
- not phased
- Status
- completed
- Start
- 2025-12-01
- Completion (planned or actual)
- 2026-07-15
- Participants
- 100 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Osteoarthritis; Type 2 Diabetes; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test L-Carnitine.
OA is a degenerative bone disease more common in postmenopausal women.
Diabetes and obesity are common risk factors for the development of OA.
The common symptoms include pain and disability of the affected joint, leading to mobility issues.
It had two arms (groups): Acetyl L-Carnitine Group (experimental) and Placebo Control Group (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
The coexistence of obesity and type 2 diabetes mellitus may aggravate the progression and severity of OA through metabolic dysfunction, chronic low-grade inflammation, oxidative stress, and altered adipokine profiles.
Acetyl L-Carnitine is a naturally occurring compound involved in mitochondrial energy metabolism.
This double-blind, placebo-controlled randomized clinical trial will enroll 100 obese, diabetic, postmenopausal women with radiologically confirmed osteoarthritis.
Clinical outcomes will include assessment of osteoarthritis symptoms using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), radiological severity using the Kellgren-Lawrence grading system, perceived stress, and depression, anxiety and stress scores.
Who Took Part
The registry lists 100 actual participants took part.
It was open to women only aged from 55 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age 55-65 years. Duration of menopause 2-15 years. Duration of diabetes 5-15 years. BMI Obese ≥30 kg/m2. Grade≥2 K\&L on radiologic examination.
The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: female patients with osteoarthritis meeting the following criteria will be excluded from the study;; age˂55 ˃65yrs; post-menopausal duration of ˂2yrs.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.
Those kept unaware of assignments: care provider and investigator.
It started in 2025-12-01 with completion listed for 2026-07-15.
It ran at 1 site in Pakistan.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Serum C-Reactive Protein Concentration (time frame: Baseline and Week 12). Fasting Blood Glucose Concentration (time frame: Baseline and Week 12). Glycated Hemoglobin (HbA1c) Percentage (time frame: Baseline and Week 12).
It also tracked 1 secondary outcome, for example Interleukin-6 (IL-6).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of L-Carnitine in 100 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the L-Carnitine compound page, all human trials.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.