36 Participants Needed

Phosphatidylserine for Type 2 Diabetes

(ADAM17 Trial)

Recruiting at 1 trial location
LM
JP
LA
Overseen ByLuis A Martinez-Lemus, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Missouri-Columbia
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Soy-derived phosphatidylserine is considered safe for older adults when taken up to 200 mg three times daily, with no significant side effects observed in studies.12345

Is the drug Phosphatidylserine promising for treating Type 2 Diabetes?

Phosphatidylserine might be promising for Type 2 Diabetes because it can influence insulin release and glucose metabolism, which are important for managing blood sugar levels.678910

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

I am between 45-64 years old with a BMI of 25-39.
No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled
I have been diagnosed with type 2 diabetes by a doctor.

Exclusion Criteria

I am on hormone replacement therapy.
I have a history of heart disease, including heart attack or stroke.
You have gained or lost more than 5% of your body weight in the last 6 months.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 weeks of supplementation with either 900mg phosphatidylserine or placebo

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Phosphatidylserine
  • Placebo
Trial Overview The study tests if phosphatidylserine (PS), a dietary supplement that inhibits ADAM17 enzyme activity can improve blood flow and vascular function in people with Type 2 Diabetes. Participants will either receive PS or a placebo to compare effects.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Phosphatidylserine SupplementationExperimental Treatment1 Intervention
Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements.
Group II: PlaceboPlacebo Group1 Intervention
Study participants will receive 4 weeks of supplementation with 900mg placebo supplements

Phosphatidylserine is already approved in United States for the following indications:

🇺🇸
Approved in United States as Phosphatidylserine for:
  • 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

Trials
387
Recruited
629,000+

Published Research Related to This Trial

Soybean transphosphatidylated phosphatidylserine (SB-tPS) was shown to significantly increase brain glucose levels in mice and restore memory in rats, indicating its potential effectiveness in improving cognitive function.
Despite differences in fatty acid composition compared to bovine brain-derived phosphatidylserine (BC-PS), SB-tPS may offer a viable alternative for preventing or improving senile dementia when taken orally.
Pharmacological effects of phosphatidylserine enzymatically synthesized from soybean lecithin on brain functions in rodents.Sakai, M., Yamatoya, H., Kudo, S.[2023]
Both bovine brain-derived (B-PSL) and soybean-derived (S-PSL) phosphatidylserine liposomes were effectively taken up by macrophage cells without significant differences in uptake rates.
Both types of liposomes significantly reduced the production of inflammatory cytokines in treated macrophages, indicating that S-PSL could be a viable anti-inflammatory agent.
Macrophage Uptake Behavior and Anti-inflammatory Response of Bovine Brain- or Soybean-derived Phosphatidylserine Liposomes.Toita, R., Fujita, S., Kang, JH.[2023]
A study involving 120 elderly participants found that soy-derived phosphatidylserine (S-PS) is safe for consumption at dosages of up to 600 mg daily, with no significant adverse effects reported over 12 weeks.
The research indicates that S-PS does not negatively impact standard health parameters, suggesting it can be a safe nutritional supplement for older adults, particularly for those with age-associated memory impairment.
Safety of soy-derived phosphatidylserine in elderly people.Jorissen, BL., Brouns, F., Van Boxtel, MP., et al.[2023]

Citations

Pharmacological effects of phosphatidylserine enzymatically synthesized from soybean lecithin on brain functions in rodents. [2023]
Macrophage Uptake Behavior and Anti-inflammatory Response of Bovine Brain- or Soybean-derived Phosphatidylserine Liposomes. [2023]
Safety of soy-derived phosphatidylserine in elderly people. [2023]
Oral administration of soybean lecithin transphosphatidylated phosphatidylserine improves memory impairment in aged rats. [2023]
Soybean-derived phosphatidylserine improves memory function of the elderly Japanese subjects with memory complaints. [2021]
Defining the importance of phosphatidylserine synthase-1 (PSS1): unexpected viability of PSS1-deficient mice. [2021]
Effect of lysophospholipids, arachidonic acid and other fatty acids on regulation of Ca2+ transport in permeabilized pancreatic islets. [2019]
Metabolism of phospholipids in peripheral nerve from rats with chronic streptozotocin-induced diabetes: increased turnover of phosphatidylinositol-4,5-bisphosphate. [2019]
Insulin inhibits changes in the phospholipid profiles in sciatic nerves from streptozocin-induced diabetic rats: a phosphorus-31 magnetic resonance study. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Group 1B phospholipase A2-mediated lysophospholipid absorption directly contributes to postprandial hyperglycemia. [2019]
Stimulation of insulin release by phospholipase D. A potential role for endogenous phosphatidic acid in pancreatic islet function. [2019]
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