OEA and LipiSperse Metabolic Study

RDC Clinical

Status and phase: Enrolling; Phase 4

Conditions: Pharmacokinetic Study in Healthy Volunteers; Healthy Volunteers - Male and Female

Treatments: Dietary Supplement: 250mg OEA with LipiSperse; Other: Placebo; Dietary Supplement: 125mg OEA with LipiSperse

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06840080

GLP1PK

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Crossover Assignment

Masking: Single Blind

---

40 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single dose of 2 capsules will be administered that appear identical to active arms.

Treatment:

Other: Placebo

125mg OEA with LipiSperse

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 125mg OEA with LipiSperse

250mg OEA with LipiSperse

Experimental group

Description:

Single dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse.

Treatment:

Dietary Supplement: 250mg OEA with LipiSperse