Effects of Plasmalogen on Obese Subjects
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Dec 2017
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2017
CompletedFirst Posted
Study publicly available on registry
September 27, 2017
CompletedStudy Start
First participant enrolled
December 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2018
CompletedFebruary 19, 2019
February 1, 2019
9 months
September 24, 2017
February 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Profile of Mood States 2nd Edition (POMS 2)
Psychological rating scale to assess transient feelings and mood
12 weeks
Secondary Outcomes (5)
Change in body weight
12 weeks
Change in waist diameter
12 weeks
Change in blood levels of plasmalogen
12 weeks
Change in Athens Insomnia Scale (AIS)
12 weeks
Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein
12 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALTwo 0.5 mg plasmalogen capsules per day
Placebo Group
PLACEBO COMPARATORTwo placebo capsules containing no plasmalogen per day
Interventions
Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.
Placebo Group takes two placebo capsules per day for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BOOCS Clinic Fukuoka
Fukuoka, 8120025, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Takehiko Fujino
BOOCS Clinic Fukuoka
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2017
First Posted
September 27, 2017
Study Start
December 8, 2017
Primary Completion
August 22, 2018
Study Completion
August 22, 2018
Last Updated
February 19, 2019
Record last verified: 2019-02