Phosphatidylserine for Type 2 Diabetes

(ADAM17 Trial)

Recruiting at 1 trial location

Overseen By Luis A Martinez-Lemus, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Immunosuppressants, Hormone therapy

Disqualifiers: Cardiovascular disease, Cancer, Autoimmune, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

36 Participants Needed

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{1 3 4 5 6}

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. ^{1 3 4 5 6}

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. ^{7 8 9 10 11}

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. ^{7 8 9 10 11}

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.

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Phosphatidylserine Supplementation Experimental Treatment 1 Intervention

Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements.

Group II: Placebo Placebo Group 1 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)

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of soy-derived phosphatidylserine in elderly people. Jorissen, BL., Brouns, F., Van Boxtel, MP., et al.[2023]

Oral administration of soybean lecithin transphosphatidylated phosphatidylserine (SB-tPS) significantly improved memory performance in aged rats over 60 days, as shown by the Morris water maze test, indicating its potential as a cognitive enhancer.

SB-tPS increased acetylcholine release and Na(+), K(+)-ATPase activity in the brains of aged rats, suggesting that its nootropic effects may be linked to these biochemical changes, similar to the effects of phosphatidylserine derived from bovine brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral administration of soybean lecithin transphosphatidylated phosphatidylserine improves memory impairment in aged rats. Suzuki, S., Yamatoya, H., Sakai, M., et al.[2023]

A study involving 78 elderly individuals with mild cognitive impairment showed that supplementation with soybean-derived phosphatidylserine (Soy-PS) for 6 months was safe, with no observed side effects or changes in vital signs.

While overall cognitive scores improved in all groups, significant memory improvements were noted in those with lower baseline scores in the Soy-PS groups, particularly in delayed verbal recall, suggesting potential benefits for early-stage dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soybean-derived phosphatidylserine improves memory function of the elderly Japanese subjects with memory complaints. Kato-Kataoka, A., Sakai, M., Ebina, R., et al.[2021]

Mice lacking the PSS1 enzyme were found to be viable and fertile, despite a significant reduction (up to 85%) in total serine-exchange activity, indicating that PSS1 is not essential for mouse survival.

The study shows that mice can tolerate a drastic reduction in phosphatidylserine (PS) and phosphatidylethanolamine levels, surviving with only 10% of normal serine-exchange activity, which suggests a remarkable adaptability in lipid metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the importance of phosphatidylserine synthase-1 (PSS1): unexpected viability of PSS1-deficient mice. Arikketh, D., Nelson, R., Vance, JE.[2021]

Lysophospholipids and unsaturated fatty acids can effectively increase calcium (Ca2+) levels in pancreatic islets from ob/ob mice, which is important for insulin secretion.

The study suggests that both lysophospholipids and inositol-1,4,5-trisphosphate (IP3) mobilize Ca2+ through different mechanisms, indicating that targeting these pathways could enhance insulin secretion in response to glucose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of lysophospholipids, arachidonic acid and other fatty acids on regulation of Ca2+ transport in permeabilized pancreatic islets. Rustenbeck, I., Lenzen, S.[2019]

Chronic diabetes induced by streptozotocin in rats leads to significant changes in phospholipid metabolism, particularly an increase in phosphatidylinositol-4,5-bisphosphate levels, which may contribute to nerve dysfunction.

The study found that while nerve conduction velocities decreased after 10 and 20 weeks of diabetes, the increase in phosphatidylinositol-4,5-bisphosphate turnover occurred as early as 2 weeks, suggesting a potential early metabolic marker for diabetic nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolism of phospholipids in peripheral nerve from rats with chronic streptozotocin-induced diabetes: increased turnover of phosphatidylinositol-4,5-bisphosphate. Bell, ME., Peterson, RG., Eichberg, J.[2019]

In a study of male Sprague-Dawley rats with diabetes, insulin treatment was found to significantly influence nerve phospholipid metabolism, particularly increasing phosphatidylcholine levels and altering the ratios of ethanolamine and choline-containing phospholipids.

Diabetic rats exhibited elevated phosphatidylcholine and decreased levels of ethanolamine plasmalogen and choline plasmalogen compared to healthy and insulin-treated rats, indicating potential disruptions in nerve lipid composition due to diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin inhibits changes in the phospholipid profiles in sciatic nerves from streptozocin-induced diabetic rats: a phosphorus-31 magnetic resonance study. Driscoll, DM., Romano, FD., Smith, CA., et al.[2019]

Mice lacking the group 1B phospholipase A2 (Pla2g1b) gene showed lower postprandial blood sugar levels after a glucose-rich meal due to improved glucose uptake in the liver, heart, and muscle tissues.

The study suggests that reducing the absorption of dietary lysophospholipids can enhance insulin sensitivity and protect against postprandial hyperglycemia, indicating a potential mechanism for preventing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group 1B phospholipase A2-mediated lysophospholipid absorption directly contributes to postprandial hyperglycemia. Labonté, ED., Kirby, RJ., Schildmeyer, NM., et al.[2019]

Exogenous phospholipases of the D type (PLD) stimulate the production of phosphatidic acid (PA) in rat pancreatic islets, which correlates closely with increased insulin secretion, indicating a potential mechanism for enhancing insulin release.

The study suggests that PLD activation leads to both immediate effects on insulin release through PA and delayed effects through the production of other lipid signals, highlighting the role of endogenous PA in regulating endocrine function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation of insulin release by phospholipase D. A potential role for endogenous phosphatidic acid in pancreatic islet function. Metz, SA., Dunlop, M.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Pharmacological effects of phosphatidylserine enzymatically synthesized from soybean lecithin on brain functions in rodents. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

Macrophage Uptake Behavior and Anti-inflammatory Response of Bovine Brain- or Soybean-derived Phosphatidylserine Liposomes. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Safety of soy-derived phosphatidylserine in elderly people. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Oral administration of soybean lecithin transphosphatidylated phosphatidylserine improves memory impairment in aged rats. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Soybean-derived phosphatidylserine improves memory function of the elderly Japanese subjects with memory complaints. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Defining the importance of phosphatidylserine synthase-1 (PSS1): unexpected viability of PSS1-deficient mice. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of lysophospholipids, arachidonic acid and other fatty acids on regulation of Ca2+ transport in permeabilized pancreatic islets. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Metabolism of phospholipids in peripheral nerve from rats with chronic streptozotocin-induced diabetes: increased turnover of phosphatidylinositol-4,5-bisphosphate. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Insulin inhibits changes in the phospholipid profiles in sciatic nerves from streptozocin-induced diabetic rats: a phosphorus-31 magnetic resonance study. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Group 1B phospholipase A2-mediated lysophospholipid absorption directly contributes to postprandial hyperglycemia. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Stimulation of insulin release by phospholipase D. A potential role for endogenous phosphatidic acid in pancreatic islet function. [2019]