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Effects of Plasmalogen on Obese Subjects

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ClinicalTrials.gov Identifier: NCT03295188
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
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

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
Estimated Study Start Date : October 2, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT03295188


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

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

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