Effects of Acetyl L-Carnitine Supplementation on Clinical, Metabolic and Inflammatory Symptoms in Obese, Diabetic, Postmenopausal Women With Osteoarthritis

June 16, 2026 updated by: Khyber Medical University Peshawar

Effects of Acetyl L-Carnitine Supplementation on Clinical, Metabolic and Inflammatory Symptoms in Obese, Diabetic, Postmenopausal Women With Osteoarthritis: Randomized Controlled Trial

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. Acetyl L-carnitine due to its known anti-inflammatory, chondroprotective, and improved insulin-sensitizing effects may help in alleviating the symptoms and progression of OA in obese diabetic postmenopausal women.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis (OA) is a chronic degenerative joint disease that commonly affects older adults and is associated with pain, stiffness, reduced mobility, and disability. 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. Postmenopausal women are particularly vulnerable because hormonal changes contribute to increased inflammation, obesity, insulin resistance, and joint degeneration.

Acetyl L-Carnitine is a naturally occurring compound involved in mitochondrial energy metabolism. Previous studies have demonstrated anti-inflammatory, antioxidant, and metabolic benefits of Acetyl L-Carnitine, including improvements in insulin resistance, lipid metabolism, oxidative stress, and inflammatory cytokine production. Experimental studies have also suggested chondroprotective effects through enhancement of cartilage matrix synthesis and mitochondrial function.

This double-blind, placebo-controlled randomized clinical trial will enroll 100 obese, diabetic, postmenopausal women with radiologically confirmed osteoarthritis. Participants will be randomly assigned to receive either Acetyl L-Carnitine (1.5 g twice daily) or placebo for 12 weeks in addition to conventional osteoarthritis treatment.

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. Laboratory outcomes will include glycemic profile, lipid profile, insulin resistance markers, inflammatory biomarkers (CRP and IL-6), oxidative stress markers, adipokines, stress hormones, and complete blood count parameters.

The study seeks to determine whether Acetyl L-Carnitine supplementation can improve clinical, metabolic, inflammatory, and radiological outcomes in obese, diabetic, postmenopausal women with osteoarthritis.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Bannu, KPK, Pakistan, 28100
        • Khalifa Gulnawaz Teaching Hospital, DHQ Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 55-65 years
  2. Duration of menopause 2-15 years.
  3. Duration of diabetes 5-15 years
  4. BMI Obese ≥30 kg/m2
  5. Grade≥2 K&L on radiologic examination

Exclusion Criteria:

  • Female patients with osteoarthritis meeting the following criteria will be excluded from the study;

    1. Age˂55 ˃65yrs
    2. Post-menopausal duration of ˂2yrs
    3. Duration of diabetes ˂ 5years
    4. Patients with alcohol abuse, asthma, cardiac disease, chronic gastric problems (malabsorption, crohn's disease chronic diarrhea), non-diabetes related renal disease,ovariectomy, rheumatoid arthritis or other rheumatic inflammatory diseases, smoking
    5. Patients taking steroids (oral/ injections)
    6. Patients with a history of parathyroid and thyroid surgery/dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetyl L-Carnitine Group
Participants will receive conventional treatment for osteoarthritis, including NSAIDs, COX-2 inhibitors, or acetaminophen as prescribed, together with Acetyl L-Carnitine capsules 1.5 g orally twice daily (total daily dose 3 g) after meals for 12 weeks. Participants will continue their usual oral antihyperglycemic medications but will not receive insulin.
Drug: Acetyl-l-carnitine
Acetyl L-Carnitine capsules, 1.5 g administered orally twice daily (total daily dose 3 g) after meals for 12 weeks in addition to conventional osteoarthritis treatment.
Other Names:
  • ALCAR, L-Carnitine (if used locally)
Placebo Comparator: Placebo Control Group
Participants will receive matching placebo capsules administered orally at a dose of two capsules daily after meals for 12 weeks, in addition to conventional osteoarthritis treatment, including NSAIDs, COX-2 inhibitors, or acetaminophen as prescribed.
Drug: Placebo
Matching placebo capsules administered orally twice daily for 12 weeks in addition to conventional osteoarthritis treatment.
Other Names:
  • Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in C-Reactive Protein (CRP)
Time Frame: Baseline and Week 12
Change in serum CRP concentration from baseline following 12 weeks of Acetyl L-Carnitine supplementation.
Baseline and Week 12
Change in Fasting Blood Glucose
Time Frame: Baseline and Week 12
Change in fasting blood glucose levels from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in Glycated Hemoglobin (HbA1c)
Time Frame: Baseline and Week 12
Change in HbA1c levels from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in Insulin Resistance (HOMA-IR)
Time Frame: Baseline and Week 12
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in Serum Insulin
Time Frame: Baseline and Week 12
Change in fasting serum insulin concentration from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in Serum Leptin
Time Frame: Baseline and Week 12
Change in serum leptin concentration from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in Serum Adiponectin
Time Frame: Baseline and Week 12
Change in serum adiponectin concentration from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in Adrenocorticotropic Hormone (ACTH)
Time Frame: Baseline and Week 12
Change in serum ACTH concentration from baseline following 12 weeks of intervention
Baseline and Week 12
Change in Malondialdehyde (MDA)
Time Frame: Baseline and Week 12
Change in serum malondialdehyde levels as a marker of oxidative stress from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in Advanced Glycation End Products (AGEs)
Time Frame: Baseline and Week 12
Change in serum AGEs levels from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in WOMAC Osteoarthritis Score
Time Frame: Baseline and Week 12
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline following 12 weeks of intervention.
Baseline and Week 12
Change in Kellgren-Lawrence Radiographic Grade
Time Frame: Baseline and Week 12
Change in osteoarthritis radiographic severity assessed by the Kellgren-Lawrence grading system from baseline following 12 weeks of intervention.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Interleukin-6 (IL-6)
Time Frame: Baseline and Week 12
Change in serum IL-6 concentration from baseline following 12 weeks of Acetyl L-Carnitine supplementation.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Medical University Peshawar

Investigators

  • Principal Investigator: Dr Safia Bibi, PhD*, Khyber Medical University Peshawar, Pakistan
  • Principal Investigator: Dr Mohsin Shah, PhD, Khyber Medical University Peshawar, Pakistan
  • Principal Investigator: Dr Zia Ullah, PhD, Khalifa Gul Nawaz Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU/DIR/CTU/2026/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in publications arising from this study will be made available to qualified researchers upon reasonable request. Shared data may include demographic characteristics, clinical outcomes, biochemical measurements, inflammatory markers, hormonal markers, and questionnaire data collected during the study. All data will be de-identified before sharing to protect participant confidentiality.

IPD Sharing Time Frame

Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound research proposal may request access to de-identified participant data. Requests will be reviewed by the principal investigator. Data will be shared following approval of the proposal and execution of an appropriate data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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