Effects of Plasmalogen on Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295188
• Other study ID #: Pls2017-01
• Status: Completed
• Phase: N/A
• Start date: December 8, 2017
• Est. completion date: August 22, 2018

Study information

• Verified date: February 2019
• Source: Japanese Plasmalogen Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Plasmalogen
Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.
• Placebo
Placebo Group takes two placebo capsules per day for 12 weeks.

Locations

Country	Name	City	State
Japan	BOOCS Clinic Fukuoka	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Japanese Plasmalogen Society

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Profile of Mood States 2nd Edition (POMS 2)	Psychological rating scale to assess transient feelings and mood	12 weeks
Secondary	Change in body weight		12 weeks
Secondary	Change in waist diameter		12 weeks
Secondary	Change in blood levels of plasmalogen		12 weeks
Secondary	Change in Athens Insomnia Scale (AIS)	Self-assessment psychometric tool to quantify sleep difficulty	12 weeks
Secondary	Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein		12 weeks