Effects of Plasmalogen on Obese Subjects

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Plasmalogen; Dietary Supplement: Placebo

• Registration Number: NCT03295188
• Lead Sponsor: Japanese Plasmalogen Society

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-24
• Study First Submitted QC: 2017-09-24
• Study First Posted: 2017-09-27
• Study Start: 2017-12-08
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Plasmalogen	Two 0.5 mg plasmalogen capsules per day
Placebo Group	Placebo	Two placebo capsules containing no plasmalogen per day

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

BOOCS Clinic Fukuoka; 🇯🇵 Fukuoka, Japan