Effects of Plasmalogen on Obese Subjects

A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03295188

Enrollment

Registered

2017-09-27

Start date

2017-12-08

Completion date

2018-08-22

Last updated

2019-02-19

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

Conditions

Obesity

Brief summary

This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen in obese subjects aged 20-75 years old.

Interventions

DIETARY_SUPPLEMENTPlasmalogen

Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.

DIETARY_SUPPLEMENTPlacebo

Placebo Group takes two placebo capsules per day for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Willingness to provide informed consent to participate in the study * BMI ≥ 25 ㎏/㎡ * HbA1C ≺ 8% without antidiabetic medication in the previous 3 months * Stable medication for 3 months prior to the enrollment, and expectedly throughout the course of study

Exclusion criteria

* Scallop allergy * Symptomatic obesity, i.e., endocrinal, hypothalamic or drug-induced obesity * Hypertension under medication with 4 or more drugs * Hepatic disorder with AST ≥ 5 times upper limit of the normal range * Mental disorder including schizophrenia and neurosis * Alcohol dependence * History of malignancy for which treatment completed in the past 5 years * Inflammatory disease * Use of plasmalogen supplement in the past 3 months * Ineligible condition as determined by study physician

Design outcomes

Primary

Measure	Time frame	Description
Change in Profile of Mood States 2nd Edition (POMS 2)	12 weeks	Psychological rating scale to assess transient feelings and mood

Secondary

Measure	Time frame	Description
Change in body weight	12 weeks	—
Change in waist diameter	12 weeks	—
Change in blood levels of plasmalogen	12 weeks	—
Change in Athens Insomnia Scale (AIS)	12 weeks	Self-assessment psychometric tool to quantify sleep difficulty
Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein	12 weeks	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026