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.

Phase 3

Recruiting

• Conditions: Gut microbiome; Gut barrier function; Gut biochemistry; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Alternative and Complementary Medicine - Other alternative and complementary medicine; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12621000017820
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-13
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in week 12 microbiome compared to baseline via faecal analysis[Baseline, Week 12];Change in week 12 metagenomic profile compared to baseline via faecal analysis[Baseline and week 12 ]

Secondary Outcome Measures

Name	Time	Method
Changes in Gut function (Permeability) via plasma assay[Baseline, Week 6 and Week 12 ];Changes in Gut function (SCFAs) via faecal analysis[Baseline, Week 12 ];Changes in inflammation markers (IFN-g, TFN-a, il-2, MCP-2, IL-1b, TGF-s, CRP) via serum assay as composite outcome[Baseline, Week 6 and Week 12 ];Changes in biochemistry (GLP-1, GST, glutathione, FABP, Homocysteine) via blood analysis as composite outcome[Baseline, Week 6 and Week 12];Changes in dietary (Kj) intake as assessed by 24-hour dietary recall diary[Baseline, Week 6 and Week 12 ];Quality of life as assessed by SF-36 Quality of Life questionnaire[Baseline, Week 6 and Week 12 ];Changes in sleep quality as assessed by Pittsburgh Sleep Quality Index[Baseline, week 6 and week 12 ];Changes in stress levels as assessed by Perceived Stress Scale (PSS)[Baseline, Week 6 and Week 12 ]