We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03295188
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Information provided by (Responsible Party):

Study Description
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
Obesity Dietary Supplement: Plasmalogen Dietary Supplement: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Anticipated Study Start Date : October 2, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018
Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

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.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03295188

Contact: Chikako Wakana +81 92 283 6852 wakana@boocsclinic.com

BOOCS Clinic Fukuoka Recruiting
Fukuoka, Japan, 8120025
Contact: Chikako Wakana    +81 92 283 6852    wakana@boocsclinic.com   
Sponsors and Collaborators
Japanese Plasmalogen Society
Study Chair: Takehiko Fujino BOOCS Clinic Fukuoka
More Information

Responsible Party: Japanese Plasmalogen Society
ClinicalTrials.gov Identifier: NCT03295188     History of Changes
Other Study ID Numbers: Pls2017-01
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

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