Nutritional Intervention to Enhance Recovery After Arthroscopic Knee Surgery in Adults

NCT06233825 | Completed

• 1 other identifier: 6038901
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Loss of skeletal muscle mass (atrophy) and strength in the lower limb are consequences of elective knee surgery as result of prolonged disuse from limb immobilization and impaired mobility, as well as pathophysiological trauma. The highest rates of skeletal muscle mass and strength loss occur during the 2-week post-surgery period, considered the early phase of outpatient recovery. Alternative to resistance exercise and pharmacology, nutritional intervention represents one strategy to combat skeletal muscle disuse atrophy. Essential amino acids (EAA) and omega-3 fatty acids are known to independently potentiate rates of skeletal muscle protein synthesis and attenuate skeletal muscle atrophy in humans. However, the combined actions these nutritional strategies on skeletal muscle have not been explored in a pathophysiological context, such as surgery. With the ultimate goal to test the efficacy of the combined nutritional strategy to attenuate skeletal muscle disuse atrophy in the future, the aim of this present pilot study is to explore the feasibility of recruitment and retention of anterior cruciate ligament reconstruction (ACLR) outpatients from a single centre across 18 months for a 6-week nutritional intervention. Participants will consume either an intervention of omega-3 fatty acids and EAAs, or a placebo control of safflower oil and non-essential amino acids (NEAA), for 4 weeks before and 2 weeks after elective ACLR surgery. Furthermore, this pilot will characterize secondary outcomes of skeletal muscle mass, strength, and power, and integrated rates of muscle protein synthesis, as well as report participant adherence to protocols and incidence of adverse events.

Conditions

Anterior Cruciate Ligament Reconstruction; Muscular Atrophy

Keywords

omega-3 fatty acids; fish oil; eicosapentaenoic acid; docosahexaenoic acid; skeletal muscle; anterior cruciate ligament; essential amino acids; magnetic resonance imaging; muscle protein synthesis

Outcome Measures

Primary Outcomes (1)

• Feasibility of Recruitment and Retention

  Number of participants recruited and retained. Criteria for success is 30 outpatients recruited and at least 22 retained.

  18 months and 12 weeks (8 weeks post surgery), respectively.

Secondary Outcomes (10)

• Muscle Mass

  0 and 2 weeks

• Muscle Cross-Sectional Area

  0 and 2 weeks

• Muscle Protein Synthesis

  -1 to 0 weeks and 0 to 2 weeks.

• Skeletal Muscle Phospholipid Composition

  -4 and 2 weeks.

• Erythrocyte Phospholipid Composition

  -4 and 2 weeks.

Study Arms (2)

Nutritional Intervention

EXPERIMENTAL

5 g omega-3 fatty acids (3.75 g eicosapentaenoic acid \[EPA\] + 1.25 g docosahexaenoic acid \[DHA\]) per day for 6 weeks, starting 4 weeks before and continuing 2 weeks after surgery, plus 40 g (2 x 20 g) of EAA per day, starting 1 week before and continuing 2 weeks after surgery.

Dietary Supplement: Omega-3 Fatty Acids and Essential Amino Acids

Placebo Control

PLACEBO COMPARATOR

5 g safflower oil per day for 6 weeks, starting 4 weeks before and continuing 2 weeks after surgery, plus 40 g (2 x 20 g) of NEAA per day, starting 1 week before and continuing 2 weeks after surgery.

Dietary Supplement: Safflower Oil and Non-Essential Amino Acids

Interventions

Omega-3 Fatty Acids and Essential Amino Acids DIETARY_SUPPLEMENT

Oil consumed as capsules. EAA come as powder to be mixed with water before drinking. 4 g of leucine per EAA dose.

Also known as: Fish Oil

Nutritional Intervention

Safflower Oil and Non-Essential Amino Acids DIETARY_SUPPLEMENT

Oil consumed as capsules. NEAA are isonitrogenous to intervention condition. Both supplement types are isoenergetic to intervention. NEAA come as powder to be mixed with water before drinking.

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed anterior cruciate ligament injury requiring reconstruction surgery
• Surgery in Kingston, ON
• Patellar tendon graft, quadriceps tendon graft, or hamstring tendon graft reconstruction procedure

You may not qualify if:

• Any muscular, neurological, respiratory, or metabolic disease, subject to investigators' discernment, would negatively affect the subject's ability to comply with the study requirements
• Any form of cancer currently or in the last 5 years
• Bleeding disorders or antiplatelet / anticoagulation therapy
• Currently taking fish oils or within the last 6 months
• Regular consumption (≥ 2x week) of fish oil or oily fish in the last 6 months
• Allergy or sensitivity to fish, shellfish or safflower oils
• Currently taking any form of steroid or within the last 6 months
• Medical inability to attain magnetic resonance imaging scans
• Known irregular responses to physical activity (e.g., shortness of breath, chest pain, dizziness, etc.)
• Surgery scheduled outside of research centre
• Scheduled surgery date \< 5 weeks away
• Pregnant or plans to become pregnant within the next 6 months
• Any current illness that impacts ability to participate in protocols

Sponsors & Collaborators

• Dr. Chris McGlory, PhD: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• Nyman DLE, Pufahl CJ, Hickey OGV, Stokes T, Simpson CA, Selinger JC, Mathur S, Janssen I, Giangregorio LM, Bardana DD, McGlory C. Nutritional intervention to enhance recovery after arthroscopic knee surgery in adults: a randomized controlled pilot trial. Pilot Feasibility Stud. 2024 Nov 12;10(1):138. doi: 10.1186/s40814-024-01561-w.

  PMID: 39533408 DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Fatty Acids, Omega-3; Amino Acids, Essential; Fish Oils; Safflower Oil

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Amino Acids; Amino Acids, Peptides, and Proteins; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Chris McGlory, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled feasibility pilot trial.Two-arm study. Half of participants are allocated to the nutritional intervention condition (5 g omega-3, 40 g essential amino acids \[EAA\] per day), and half to the placebo control condition (5 g safflower oil, 40 g non-essential amino acids \[NEAA\] per day).

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 31, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 14, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)