Effects of Plasmalogen on Obese Subjects

Japanese Plasmalogen Society

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Plasmalogen

Study type: Interventional

Funder types: Other

Identifiers

NCT03295188

Pls2017-01

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

Two 0.5 mg plasmalogen capsules per day

Treatment:

Dietary Supplement: Plasmalogen

Placebo Group

Placebo Comparator group

Description:

Two placebo capsules containing no plasmalogen per day

Treatment:

Dietary Supplement: Placebo