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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.
 
ClinicalTrials.gov Identifier: NCT03295188
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Japanese Plasmalogen Society

Tracking Information
First Submitted Date  ICMJE September 24, 2017
First Posted Date  ICMJE September 27, 2017
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE December 8, 2017
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2017)
Change in Profile of Mood States 2nd Edition (POMS 2) [ Time Frame: 12 weeks ]
Psychological rating scale to assess transient feelings and mood
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2017)
  • Change in body weight [ Time Frame: 12 weeks ]
  • Change in waist diameter [ Time Frame: 12 weeks ]
  • Change in blood levels of plasmalogen [ Time Frame: 12 weeks ]
  • Change in Athens Insomnia Scale (AIS) [ Time Frame: 12 weeks ]
    Self-assessment psychometric tool to quantify sleep difficulty
  • Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Plasmalogen on Obese Subjects
Official Title  ICMJE A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Plasmalogen
    Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.
  • Dietary Supplement: Placebo
    Placebo Group takes two placebo capsules per day for 12 weeks.
Study Arms  ICMJE
  • Experimental: Intervention Group
    Two 0.5 mg plasmalogen capsules per day
    Intervention: Dietary Supplement: Plasmalogen
  • Placebo Comparator: Placebo Group
    Two placebo capsules containing no plasmalogen per day
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2019)
83
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2017)
80
Actual Study Completion Date  ICMJE August 22, 2018
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03295188
Other Study ID Numbers  ICMJE Pls2017-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Japanese Plasmalogen Society
Study Sponsor  ICMJE Japanese Plasmalogen Society
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Takehiko Fujino BOOCS Clinic Fukuoka
PRS Account Japanese Plasmalogen Society
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP