Effect of Palmitoylethanolamide (PEA) and Oleoylethanolamide (OEA) Compared to a Placebo on the Gut Microbiome in an Adult Population – A double blind, randomised controlled trial.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000017820

Acronym

OEA-GUT20

Enrollment

120

Registered

2021-01-13

Start date

2021-03-01

Completion date

2024-02-13

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Effect of Palmitoylethanolamide (PEA) and Oleoylethanolamide (OEA) Compared to a Placebo on the Gut Microbiome in an Adult Population – A double blind, randomised controlled trial. The aim of this study is to assess the effectiveness of PEA and OEA for altering the gut microbiome diversity and population compared to a placebo in overweight but otherwise healthy adults aged 18-65 years old.

Interventions

PEA is a TGA approved ingredient for use in listed medicines in Australia (Brand name Levagen+). OEA, a metabolite of oleic acid, is a bioactive endocannabinoid-like lipid signalling molecule belonging to the acylglycerol and N-acylethanolamine (NAE) family of endocannabinoids. PEA (Levagen+) will be taken at a dose of 600mg daily (1 capsule in the morning and one in the evening) for the duration of the intervention period (12 weeks). OEA will be taken at a dose of 300mg daily (1 capsule in the morning and 1 in the evening) for the duration of the intervention period (12 weeks). Once enrolled in the study, participants will attend the clinic and be randomly allocated to either a placebo group or one of two active intervention groups (OEA and PEA). Participants will be required to complete a number of baseline tests before starting trial product. Participants will be required to complete 4 questionnaires online, provide a blood sample (approximately 20 mL) and basic anthropometric measures before attending an imaging centre for a liver scan. Participants will also be provided with a faecal sample collection kit (with instructions) to take home and provide a baseline sample for microbiome testing. Once all baseline measures have been completed participants will start consuming the allocated study product according to the dose prescribed. During the 3-month study period, participants will be asked to undertake identical testing at week 6 (mid-point) and week-12 (end-point) of the study. The exceptions are some blood analysis, microbiome testing and the liver scan which will not be undertaken at week 6. Adherence will be monitored by return and logging of any remaining study product at completion of intervention period.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

• Male and females aged 18-65 years old • Able to provide informed consent • BMI 30-40kg/m2

Exclusion criteria

• Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, Malignancy, lung conditions, chronic asthma and mood disorders or neurological disorders such as MS)(a). • Acute sickness experienced within the past 2 months • Current use of medications (e.g. antibiotics) or supplements (e.g. pre- and probiotics) that alter the microbiome or gut health. Any use during the trial will result in exclusion from the study. • Active smokers and/or nicotine or drug abuse • Chronic alcohol use (>14 alcoholic drinks week) • Allergic to any of the ingredients in active or placebo formula • Pregnant or lactating woman • Females of child bearing potential not using a highly effective form of contraception (b,c) (i.e. methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly like the oral contraception pill, birth control implant e.g. implanon) (b,c). • People medically prescribed medications that would affect the immune and/or the inflammatory response (e.g. NSAIDs, steroids, antibiotics). • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion • Participants who have participated in any other related clinical study during the past 1 month • People with cognitive damage • People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year a An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. b Examples of acceptable forms of highly effective contraception include: • Established use of oral, injected or implanted hormonal methods of contraception. • Placement of an intrauterine device (IUD) or intrauterine system (IUS). • Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). • True abstinence: When this is in line with your preferred and usual lifestyle c Examples of non-acceptable methods of contraception include: • Condoms alone or double barrier • Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation) • Withdrawal • Spermicide (as it is not approved as a method of contraception in Australia)

Outcome results