Effect of PEA on Muscle Recovery Following Resistance Exercise

NCT05753111 | Completed

• 1 other identifier: S67315
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of short term palmitoylethanolamide (PEA) supplementation on functional responses (i.e. muscle soreness and performance parameters) to strenuous eccentric exercise, and investigateq the systemic and muscle molecular mechanisms through which PEA impacts on these functional responses.

Conditions

Muscle Recovery; Muscle Soreness

Keywords

PEA; Skeletal muscle

Outcome Measures

Primary Outcomes (7)

• Isometric muscle strength

  Maximal isometric peak torque (N x m) assessed via Promett

  4 months

• Eccentric muscle strength

  Eccentric isometric peak torque (N x m) assessed via Promett

  4 months

• Concentric muscle strength

  Concentricisometric peak torque (N x m) assessed via Promett

  4 months

• Jump height

  2 leg jump height on a force platform (m)

  4 months

• Plasma concentrations of PEA, creatine kinase (CK), IL-6 and TNFα

  Plasma concentrations of PEA, creatine kinase (CK), IL-6 and TNFα

  4 months

• Muscle inflammatory signaling

  pro- and anti-inflammatory cytokine expression (TNFα, IL-6, IL-10, IL-4) assessed via western blotting and PCR (arbitrary units)

  4 months

• Muscle immune cell infiltration

  immune cell infiltration (macrophages and neutrophils) (number/area) assessed via histological analyses of muscle biopsies

  4 months

Secondary Outcomes (3)

• Dietary behaviour

  4 months

• Perceived sleep quality

  4 months

• Perceived sleep quantity

  4 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants receive placebo supplements on two separate occasions in a randomized order. The placebo supplements contain 350 mg of maltodextrine. Placebo supplements are packaged in non-see-through hard capsules to assure that there are no differences in appearance or taste. Participants are instructed to ingest their supplement twice a day (in the morning and one hour before bedtime) for 6 consecutive days starting after collection of baseline measures.

Dietary Supplement: PLACEBO

Palmitoylethanolamide (PEA) supplementation

EXPERIMENTAL

Participants receive PEA supplements on two separate occasions in a randomized order. The PEA supplements contain 350 mg of Levagen+ (315 mg of PEA and 35 mg of excipients). Levagen+ consists for 90% of palmitoylethanolamide and for 10% of a mixture of coconut oil (fractionated), polyglycerol polyricinoleate, citrus oil, olive oil, lecithin, dl-alpha tocopheryl acetate, and silicon dioxide to improve the bioavailability of PEA. Both PEA supplements are packaged in non-see-through hard capsules to assure that there are no differences in appearance or taste. Participants are instructed to ingest their supplement twice a day (in the morning and one hour before bedtime) for 6 consecutive days starting after collection of baseline measures.

Dietary Supplement: PEA

Interventions

PEA DIETARY_SUPPLEMENT

PEA supplementation

Also known as: Levagen+

Palmitoylethanolamide (PEA) supplementation

PLACEBO DIETARY_SUPPLEMENT

Maltodextrin supplementation

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males between 18 and 35 years old
• Non-elite athletes (training load \> 5h/wk)
• Good health status confirmed by a medical screening
• Body Mass Index (BMI) between 18 and 25 kg/m2
• Masters the Dutch language

You may not qualify if:

• Participant has a history of smoking
• Concomitant participation in another interventional Trial (e.g. with an investigational medicinal product, medical device or experimental surgical technique)
• Involvement in a structural resistance training program 6 months prior to the start of the experimental trial
• Any kind of injury/incapability that is a contra-indication to perform high-intensity resistance exercise
• Intake of any performance enhancing medication or nutritional supplement 6 months prior to the start of the experimental trial
• Use of PEA supplements or CBD related products (including CBD oil, cannabis or other substances containing cannabinoids) 1 year prior to the start of the experimental trial
• Blood donation within 3 months prior to the start of the experimental trial

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Exercise Physiology Research Group

Leuven, 3001, Belgium

Location

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katrien Koppo, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding: To avoid bias, treatment arms will be blinded to Investigators/Trial staff/participants, as follows: the supplement will be manufactured, packaged and labelled in such a way that the visual appearance, nor the smell and/or touch of the supplement can be distinguished from the placebo. Supplements are delivered to the participants by a member of the research group that is not involved in any of the experimental procedures or analyses. Furthermore, to maintain the blind, the supplement and placebo will follow the same administration route and process.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher

Model Details: Double-blind, placebo-controlled, crossover trial design

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: March 3, 2023
• Study Start: February 16, 2023
• Primary Completion: May 16, 2023
• Study Completion: May 26, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)