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OEA and LipiSperse Metabolic Study

PHASE4COMPLETED

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

  1. Have a serious illness e.g. neurological disorders such as MS, kidney disease, liver disease or heart conditions
  2. History of any glucose or insulin regulation problem, including diabetes.
  3. Have an unstable illness e.g. thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar).
  4. Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinemia, hypoglycaemia.
  5. Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin.
  6. Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
  7. Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)
  8. Active smokers, nicotine use or drug (prescription or illegal substances) abuse
  9. Chronic past and/or current alcohol use (>21 alcoholic drinks week)
  10. Pregnant or lactating women
  11. Allergic to any of the ingredients in active or placebo formula
  12. 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).
  13. Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
  14. Regular use within the past 4 weeks of supplements containing OEA and/or LipiSperse

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: FEMALE

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

OTHER

phase

Phase

    PHASE4

trial

Study ID

NCT06840080

Intervention or treatment

OTHER: Placebo

DIETARY_SUPPLEMENT: 125mg OEA with LipiSperse

DIETARY_SUPPLEMENT: 250mg OEA with LipiSperse

Conditions

  • Healthy Volunteers - Male and Female
  • Pharmacokinetic Study in Healthy Volunteers

  • Condition: Healthy Volunteers - Male and Female, Pharmacokinetic Study in Healthy Volunteers

  • OTHER: Placebo and other drugs

  • Brisbane, Queensland, Australia

  • Sponsor: RDC Clinical Pty Ltd

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

RDC Clinical

Select from list below to view details:

  • RDC Clinical

    Brisbane, Queensland, Australia

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Who is running the clinical trial?

RCPL

RDC Clinical Pty Ltd

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
PLACEBO_COMPARATOR: Placebo
  • Single dose of 2 capsules will be administered that appear identical to active arms.
Other: Placebo
    EXPERIMENTAL: 125mg OEA with LipiSperse
    • Single dose of 2 capsules will be administered. 1 capsule will contain 125mg OEA and 13.9mg of LipiSperse and 1 capsule will be a placebo.
    Dietary Supplement: 125mg OEA with LipiSperse
      EXPERIMENTAL: 250mg OEA with LipiSperse
      • Single dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse.
      Dietary Supplement: 250mg OEA with LipiSperse

        What is the study measuring?

        Primary Outcome

        MeasureDescriptionTime Frame
        Changes in serum/plasma GLP-1 AUCChange from baseline to the end of the study period in serum/plasma GLP-1 AUC for each arm of treatment.Baseline and 8 hours

        Secondary Outcome

        MeasureDescriptionTime Frame
        Changes in serum/plasma GIP AUCChange from baseline to the end of the study period in serum/plasma GIP AUC for each of the 3 arms.Baseline and 8 hours
        Changes in serum/plasma DPP-4 AUCChange from baseline to the end of the study period in serum/plasma DPP-4 AUC for each of the 3 arms.Baseline and 8 hours
        Changes in serum/plasma glucagon AUCChange from baseline to the end of the study period in serum/plasma glucagon AUC for each of the 3 arms.Baseline and 8 hours
        Changes in serum/plasma glucose AUCChange from baseline to the end of the study period in serum/plasma glucose AUC for each of the 3 arms.Baseline and 8 hours
        Changes in serum/plasma insulin AUCChange from baseline to the end of the study period in serum/plasma insulin AUC for each of the 3 arms.Baseline and 8 hours
        Tmax of GLP-1Tmax of GLP-1 for each of the 3 arms.Baseline to 8 hours
        Tmax of GIPTmax of GIP for each of the 3 arms.Baseline to 8 hours
        Tmax of DPP-4Tmax of DPP-4 for each of the 3 arms.Baseline to 8 hours
        Tmax of glucagonTmax of glucagon for each of the 3 arms.Baseline to 8 hours
        Tmax of glucoseTmax of glucose for each of the 3 arms.Baseline to 8 hours
        Tmax of insulinTmax of insulin for each of the 3 arms.Baseline to 8 hours
        Cmax of GLP-1Cmax of GLP-1 for each of the 3 arms.Baseline to 8 hours
        Cmax of GIPCmax of GIP for each of the 3 arms.Baseline to 8 hours
        Cmax of DPP-4Cmax of DPP-4 for each of the 3 arms.Baseline to 8 hours
        Cmax of glucagonCmax of glucagon for each of the 3 arms.Baseline to 8 hours
        Cmax of glucoseCmax of glucose for each of the 3 arms.Baseline to 8 hours
        Cmax of insulinCmax of insulin for each of the 3 arms.Baseline to 8 hours
        Individual absorption data for each subjectIndividual 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.Baseline to 8 hours
        Tolerability including GIT toleranceTolerability including Gastrointestinal (GIT) tolerance. A GIT tolerance questionnaire will be administered prior to lunch. Will be reviewed for each of the 3 armsBaseline to 8 hours
        Safety via AE monitoringSafety via AE monitoring for each of the 3 armsBaseline to 8hours post dose
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GLP-1)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in GLP-1 over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GIP)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in GIP over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in DPP-4)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in DPP-4 over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucagon)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in glucagon over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucose)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in glucose over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in insulin)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in insulin over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GLP-1)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of GLP-1 over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GIP)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of GIP over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of DPP-4)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of DPP-4 over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucagon)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of glucagon over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucose)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of glucose over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of insulin)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of insulin over 8-hoursBaseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GLP-1)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of GLP-1 over 8-hours.Baseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GIP)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for GIP over 8-hours.Baseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of DPP-4)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of DPP-4 over 8-hours.Baseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucagon)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of glucagon over 8-hours.Baseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucose)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of glucose over 8-hours.Baseline to 8 hours
        Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of insulin)Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of insulin over 8-hours.Baseline to 8 hours
        VAS for appetiteA 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.Baseline to 4 hours
        Food consumption during the time in clinic (Lunch)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.Baseline to 8 hours.
        Food consumption during the time in clinic (Breakfast)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.Baseline to 8 hours.
        Food consumption during the time in clinic (snacks)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 differencesBaseline to 8 hours.
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        References

        Clinical Trials Gov: OEA and LipiSperse Metabolic Study

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