Effects of Plasmalogen on Obese Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Plasmalogen; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 8120025
    • Boocs Clinic Fukuoka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; Two 0.5 mg plasmalogen capsules per day	Dietary supplement: Plasmalogen; Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.
PLACEBO_COMPARATOR: Placebo Group; Two placebo capsules containing no plasmalogen per day	Dietary supplement: Placebo; Placebo Group takes two placebo capsules per day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Self-assessment psychometric tool to quantify sleep difficulty	12 weeks
Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein		12 weeks

Collaborators and Investigators

• Sponsor: Japanese Plasmalogen Society
• Investigators: Study Chair: Takehiko Fujino, Boocs Clinic Fukuoka

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2017
• Primary Completion (ACTUAL): August 22, 2018
• Study Completion (ACTUAL): August 22, 2018

Study Registration Dates

• First Submitted: September 24, 2017
• First Submitted That Met QC Criteria: September 24, 2017
• First Posted (ACTUAL): September 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pls2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No