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Clinical Trials/NCT03295188
NCT03295188CompletedNot Applicable

A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects

Japanese Plasmalogen Society2 sites in 1 country83 target enrollmentStarted: December 8, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
83
Locations
2
Primary Endpoint
Change in Profile of Mood States 2nd Edition (POMS 2)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Intervention Group

Experimental

Two 0.5 mg plasmalogen capsules per day

Intervention: Plasmalogen (Dietary Supplement)

Placebo Group

Placebo Comparator

Two placebo capsules containing no plasmalogen per day

Intervention: Placebo (Dietary Supplement)

Outcomes

Primary Outcomes

Change in Profile of Mood States 2nd Edition (POMS 2)

Time Frame: 12 weeks

Psychological rating scale to assess transient feelings and mood

Secondary Outcomes

  • Change in waist diameter(12 weeks)
  • Change in body weight(12 weeks)
  • Change in Athens Insomnia Scale (AIS)(12 weeks)
  • Change in blood levels of plasmalogen(12 weeks)
  • Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein(12 weeks)

Investigators

Sponsor
Japanese Plasmalogen Society
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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