Status:
COMPLETED
Effects of Plasmalogen on Obese Subjects
Lead Sponsor:
Japanese Plasmalogen Society
Conditions:
Obesity
Eligibility:
All Genders
20-75 years
Phase:
NA
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 sub...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2018
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03295188
Start Date
December 8 2017
End Date
August 22 2018
Last Update
February 19 2019
Active Locations (1)
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1
BOOCS Clinic Fukuoka
Fukuoka, Japan, 8120025