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OpenTrials
Completed

NCT Number: NCT03295188

Effects of Plasmalogen on Obese Subjects

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BOOCS Clinic Fukuoka

Fukuoka, 8120025, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmalogen

Dietary Supplement

Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.

Placebo

Dietary Supplement

Placebo Group takes two placebo capsules per day for 12 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Japanese Plasmalogen Society

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2017
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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