Phosphatidylserine for Type 2 Diabetes
(ADAM17 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a dietary supplement called phosphatidylserine to see if it can help improve blood flow in people with Type 2 Diabetes. The supplement works by blocking an enzyme that affects blood vessels. Researchers will compare the effects of the supplement over a period of time.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant or hormone replacement therapy, you are not eligible to participate.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressant or hormone replacement therapy, you may not be eligible to participate.
What safety data exists for phosphatidylserine treatment?
Phosphatidylserine, particularly soy-derived, has been studied for safety in elderly populations. A study involving 120 elderly participants found that soy-phosphatidylserine (S-PS) at dosages of 300 mg and 600 mg daily was safe, with no significant differences in safety parameters compared to placebo. Another study with 78 elderly Japanese subjects reported no adverse effects or changes in blood markers and vital signs during 6 months of Soy-PS treatment. These findings suggest that soy-derived phosphatidylserine is a safe supplement for older adults.12345
Is phosphatidylserine safe for human use?
Is the drug Phosphatidylserine promising for treating Type 2 Diabetes?
How does the drug Phosphatidylserine work differently for type 2 diabetes?
Phosphatidylserine may influence insulin secretion by affecting calcium mobilization in pancreatic cells, which is different from other diabetes treatments that primarily focus on insulin sensitivity or glucose absorption. This unique mechanism could potentially offer a novel approach to managing type 2 diabetes by directly impacting insulin release.678910
What data supports the idea that Phosphatidylserine for Type 2 Diabetes is an effective treatment?
The available research does not provide direct evidence that Phosphatidylserine is an effective treatment for Type 2 Diabetes. The studies mainly focus on its effects on brain functions, memory improvement, and anti-inflammatory responses. For example, one study showed that soybean-derived Phosphatidylserine improved memory in elderly people with memory complaints, and another study indicated its potential as an anti-inflammatory agent. However, there is no specific data supporting its use for Type 2 Diabetes.123511
What evidence supports the effectiveness of the treatment Phosphatidylserine for Type 2 Diabetes?
Research shows that phosphatidylserine, especially when derived from soybeans, has been effective in improving memory and cognitive functions in elderly individuals with memory complaints. It also has anti-inflammatory properties, which might be beneficial for managing conditions like Type 2 Diabetes, although direct evidence for diabetes is not provided.123511
Are You a Good Fit for This Trial?
This trial is for men and women aged 45-64 with Type 2 Diabetes, a BMI of 25-39 kg/m2, and no recent significant weight change. It excludes those with active cancer, autoimmune diseases, heavy alcohol use, chronic kidney or liver disease, current smokers, cardiovascular conditions, on immunosuppressants or hormone therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 weeks of supplementation with either 900mg phosphatidylserine or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Phosphatidylserine
- Placebo
Phosphatidylserine is already approved in United States for the following indications:
- Dietary management of certain lipid imbalances associated with attention-deficit/hyperactivity disorder (ADHD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Missouri-Columbia
Lead Sponsor