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Effects of Plasmalogen on Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03295188
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : February 19, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Plasmalogen Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects
Actual Study Start Date : December 8, 2017
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

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.

Primary Outcome Measures :
  1. Change in Profile of Mood States 2nd Edition (POMS 2) [ Time Frame: 12 weeks ]
    Psychological rating scale to assess transient feelings and mood

Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: 12 weeks ]
  2. Change in waist diameter [ Time Frame: 12 weeks ]
  3. Change in blood levels of plasmalogen [ Time Frame: 12 weeks ]
  4. Change in Athens Insomnia Scale (AIS) [ Time Frame: 12 weeks ]
    Self-assessment psychometric tool to quantify sleep difficulty

  5. Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03295188

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BOOCS Clinic Fukuoka
Fukuoka, Japan, 8120025
Sponsors and Collaborators
Japanese Plasmalogen Society
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Study Chair: Takehiko Fujino BOOCS Clinic Fukuoka
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Responsible Party: Japanese Plasmalogen Society Identifier: NCT03295188    
Other Study ID Numbers: Pls2017-01
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No