ObesityNCT03295188
Effects of Plasmalogen on Obese Subjects
A study testing Plasmalogen in people with Obesity, run by Japanese Plasmalogen Society at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Plasmalogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteJapan
- Study dates
- 8 Dec 2017to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived 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.
- Conditions
- Obesity
- Being tested
- Plasmalogen, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmalogenDietary supplement
Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.
PlaceboDietary supplement
Placebo Group takes two placebo capsules per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Two 0.5 mg plasmalogen capsules per day Receives: Dietary Supplement: Plasmalogen |
| Placebo Group | Placebo comparator | Two placebo capsules containing no plasmalogen per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Profile of Mood States 2nd Edition (POMS 2)
Psychological rating scale to assess transient feelings and mood
Measured: 12 weeks
Secondary outcomes (5)
Change in body weight
Measured: 12 weeks
Change in waist diameter
Measured: 12 weeks
Change in blood levels of plasmalogen
Measured: 12 weeks
Change in Athens Insomnia Scale (AIS)
Self-assessment psychometric tool to quantify sleep difficulty
Measured: 12 weeks
Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start8 Dec 2017
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japanese Plasmalogen Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Takehiko Fujino, Study chair, BOOCS Clinic Fukuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295188
- Sponsor's protocol ID
- Pls2017-01
- Status last verified
- Feb 2019
- First submitted
- 24 Sep 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects
- ClinicalTrials.gov ID
- NCT03295188
- Acronym / sponsor ID
- Pls2017-01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Japanese Plasmalogen SocietyUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: PlasmalogenTwo 0.5 mg plasmalogen capsules per day |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboTwo placebo capsules containing no plasmalogen per day |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasmalogenTreatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks. | Dietary supplement | Intervention Group |
| PlaceboPlacebo Group takes two placebo capsules per day for 12 weeks. | Dietary supplement | Placebo Group |
Primary outcome
Change in Profile of Mood States 2nd Edition (POMS 2)
Time frame: 12 weeks
Psychological rating scale to assess transient feelings and mood
5 secondary outcomes
Change in body weight
Time frame: 12 weeks
Change in waist diameter
Time frame: 12 weeks
Change in blood levels of plasmalogen
Time frame: 12 weeks
Change in Athens Insomnia Scale (AIS)
Time frame: 12 weeks
Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
Related trials for Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takehiko Fujino study chair
BOOCS Clinic Fukuoka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmalogen in people with Obesity, run by Japanese Plasmalogen Society at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Profile of Mood States 2nd Edition (POMS 2) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.