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Completed

NCT Number: NCT06840080

OEA and LipiSperse Metabolic Study

A placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (OEA) with LipiSperse supplementation on metabolic pathways in healthy participants.

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Key information

Conditions

Healthy Volunteers - Male and Female Pharmacokinetic Study in Healthy Volunteers

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RDC Clinical

Brisbane, Queensland, 4006, Australia

About this study

This study aims to compare the metabolic effects of two different doses of OEA with LipiSperse to a placebo in healthy participants over an 8-hour period. There are three trial arms in this study. Each participant will complete all 3 arms of the study, for a 3-way cross-over.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 30 years and older
  • Generally healthy
  • BMI 25.0-34.9 kg/m2
  • Able to provide informed consent
  • Agree to not participate in another clinical trial while enrolled in this trial
  • Agree not to change current diet and/or exercise frequency or intensity during entire study period
  • Females using a prescribed form of birth control (e.g. oral contraceptive)
  • Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points

Exclusion criteria

  • Have a serious illness e.g. neurological disorders such as MS, kidney disease, liver disease or heart conditions
  • History of any glucose or insulin regulation problem, including diabetes.
  • Have an unstable illness e.g. thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar).
  • Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinemia, hypoglycaemia.
  • Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin.
  • Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
  • Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)
  • Active smokers, nicotine use or drug (prescription or illegal substances) abuse
  • Chronic past and/or current alcohol use (>21 alcoholic drinks week)
  • Pregnant or lactating women
  • Allergic to any of the ingredients in active or placebo formula
  • Participants who are or who have participated in any other clinical trial during the past 1 month (excludes RDC clinical trials which are to be assessed on a case-by-case basis).
  • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
  • Regular use within the past 4 weeks of supplements containing OEA and/or LipiSperse

Treatment and study plan

Placebo

Other

Single dose of 2 capsules. Capsules contain the same excipients as the active arms, except for the OEA with LipiSperse in capsules that appear identical to the OEA with LipiSperse capsules

125mg OEA with LipiSperse

Dietary Supplement

Single dose of 2 capsules. 1 capsule contains 125mg of OEA and 13.9mg of LipiSperse, the other capsule is a placebo.

Other names: 125mg oleoylethanolamide

250mg OEA with LipiSperse

Dietary Supplement

Single dose of 2 capsules. Each capsule contains 125mg of OEA and 13.9mg of LipiSperse.

Other names: 250mg oleoylethanolamide

Primary outcomes

  1. Changes in serum/plasma GLP-1 AUC

    Time frame: Baseline and 8 hours

    Change from baseline to the end of the study period in serum/plasma GLP-1 AUC for each arm of treatment.

Secondary outcomes

  1. Changes in serum/plasma GIP AUC

    Time frame: Baseline and 8 hours

    Change from baseline to the end of the study period in serum/plasma GIP AUC for each of the 3 arms.

  2. Changes in serum/plasma DPP-4 AUC

    Time frame: Baseline and 8 hours

    Change from baseline to the end of the study period in serum/plasma DPP-4 AUC for each of the 3 arms.

  3. Changes in serum/plasma glucagon AUC

    Time frame: Baseline and 8 hours

    Change from baseline to the end of the study period in serum/plasma glucagon AUC for each of the 3 arms.

  4. Changes in serum/plasma glucose AUC

    Time frame: Baseline and 8 hours

    Change from baseline to the end of the study period in serum/plasma glucose AUC for each of the 3 arms.

  5. Changes in serum/plasma insulin AUC

    Time frame: Baseline and 8 hours

    Change from baseline to the end of the study period in serum/plasma insulin AUC for each of the 3 arms.

  6. Tmax of GLP-1

    Time frame: Baseline to 8 hours

    Tmax of GLP-1 for each of the 3 arms.

  7. Tmax of GIP

    Time frame: Baseline to 8 hours

    Tmax of GIP for each of the 3 arms.

  8. Tmax of DPP-4

    Time frame: Baseline to 8 hours

    Tmax of DPP-4 for each of the 3 arms.

  9. Tmax of glucagon

    Time frame: Baseline to 8 hours

    Tmax of glucagon for each of the 3 arms.

  10. Tmax of glucose

    Time frame: Baseline to 8 hours

    Tmax of glucose for each of the 3 arms.

  11. Tmax of insulin

    Time frame: Baseline to 8 hours

    Tmax of insulin for each of the 3 arms.

  12. Cmax of GLP-1

    Time frame: Baseline to 8 hours

    Cmax of GLP-1 for each of the 3 arms.

  13. Cmax of GIP

    Time frame: Baseline to 8 hours

    Cmax of GIP for each of the 3 arms.

  14. Cmax of DPP-4

    Time frame: Baseline to 8 hours

    Cmax of DPP-4 for each of the 3 arms.

  15. Cmax of glucagon

    Time frame: Baseline to 8 hours

    Cmax of glucagon for each of the 3 arms.

  16. Cmax of glucose

    Time frame: Baseline to 8 hours

    Cmax of glucose for each of the 3 arms.

  17. Cmax of insulin

    Time frame: Baseline to 8 hours

    Cmax of insulin for each of the 3 arms.

  18. Individual absorption data for each subject

    Time frame: Baseline to 8 hours

    Individual change data obtained for serum/plasma GLP-1, GIP, DPP-4, glucagon, glucose and insulin from each participant for each of the 3 study arms will be individually compared for change. Individual results will then be combined for whole group comparison/analysis.

  19. Tolerability including GIT tolerance

    Time frame: Baseline to 8 hours

    Tolerability including Gastrointestinal (GIT) tolerance. A GIT tolerance questionnaire will be administered prior to lunch. Will be reviewed for each of the 3 arms

  20. Safety via AE monitoring

    Time frame: Baseline to 8hours post dose

    Safety via AE monitoring for each of the 3 arms

  21. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GLP-1)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in GLP-1 over 8-hours

  22. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GIP)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in GIP over 8-hours

  23. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in DPP-4)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in DPP-4 over 8-hours

  24. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucagon)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in glucagon over 8-hours

  25. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucose)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in glucose over 8-hours

  26. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in insulin)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in insulin over 8-hours

  27. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GLP-1)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of GLP-1 over 8-hours

  28. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GIP)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of GIP over 8-hours

  29. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of DPP-4)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of DPP-4 over 8-hours

  30. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucagon)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of glucagon over 8-hours

  31. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucose)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of glucose over 8-hours

  32. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of insulin)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of insulin over 8-hours

  33. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GLP-1)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of GLP-1 over 8-hours.

  34. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GIP)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for GIP over 8-hours.

  35. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of DPP-4)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of DPP-4 over 8-hours.

  36. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucagon)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of glucagon over 8-hours.

  37. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucose)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of glucose over 8-hours.

  38. Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of insulin)

    Time frame: Baseline to 8 hours

    Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of insulin over 8-hours.

  39. VAS for appetite

    Time frame: Baseline to 4 hours

    A visual analogue scale (VAS) for appetite will be administered 3.5 - 4 hours after dosing, and will be assessed for each of the 3 arms.

  40. Food consumption during the time in clinic (Lunch)

    Time frame: Baseline to 8 hours.

    Participants will be supplied with a standardised lunch meal of known nutritional value (i.e., calories, carbohydrate, fat and protein content). Each participants food will be provided to them via a standardised container (i.e., the same dimension with foods segregated). Prior to and upon completion of the meal, all meal containers will be photographed. The photos will be used to assess the percentage of food that was consumed at each of the 3 visits.

  41. Food consumption during the time in clinic (Breakfast)

    Time frame: Baseline to 8 hours.

    Participants will be supplied with a standardised breakfast meal of known nutritional value (i.e., calories, carbohydrate, fat and protein content). Each participants food will be provided to them via a standardised container (i.e., the same dimension with foods segregated). Prior to and upon completion of the meal, all meal containers will be photographed. The photos will be used to assess the percentage of food that was consumed at each of the 3 visits.

  42. Food consumption during the time in clinic (snacks)

    Time frame: Baseline to 8 hours.

    Any snacks consumed during the day (baseline to 8-hours) at each visit will be recorded. The number of snacks consumed during each visit will be assessed as a numerical number (i.e., number of biscuits or pieces of fruit). The difference in snacks consumed at each visit will then be analysed for any differences

Other outcomes

  1. E/LFT for triglycerides, cholesterol and safety markers

    Time frame: Baseline and 8 hours

    Electrolyte/Liver Function Test (E/LFT) for triglycerides, cholesterol and safety markers for each arm. Samples will be analysed for a range of safety biomarkers within the E/LFT including Sodium, Potassium, Chloride, Bicarbonate, Calcium.

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Gencor Pacific Limited, Hong Kong

Registry information

Official study title

Short-term Effect of Oleoylethanolamide (OEA) and LipiSperse Supplementation on Metabolic Pathways in Otherwise Healthy Participants - a Single Blind, Cross-over Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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