Phosphatidylserine for Type 2 Diabetes

(ADAM17 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a dietary supplement called phosphatidylserine can help people with type 2 diabetes improve blood flow and vascular health. Researchers aim to determine if this supplement offers benefits compared to a placebo (a pill with no active ingredients). Participants will receive either the phosphatidylserine supplement or a placebo for four weeks. The trial seeks individuals diagnosed with type 2 diabetes who do not have major heart, kidney, or liver problems. As an unphased trial, this study provides a unique opportunity to contribute to understanding potential new benefits of phosphatidylserine for diabetes management.

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.

Is there any evidence suggesting that phosphatidylserine is likely to be safe for humans?

Research has shown that phosphatidylserine is generally safe as a supplement. The FDA considers it "generally recognized as safe" (GRAS) when derived from soy, fish, or sunflower. This designation means it is safe to consume in typical amounts found in food or supplements.

Studies suggest that taking phosphatidylserine orally is likely safe for up to three months. Some individuals might experience mild side effects, such as trouble sleeping or an upset stomach, but these are uncommon and usually not serious.

Overall, phosphatidylserine is considered safe, which is why it is often used for health purposes. For those considering participation in a trial with this supplement, research supports its general safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for type 2 diabetes, which often involve medications like metformin or insulin to manage blood sugar levels, phosphatidylserine is a unique supplement that targets cell membrane health. Researchers are excited about phosphatidylserine because it is a naturally occurring phospholipid that could improve insulin sensitivity by supporting the integrity and function of cell membranes. This approach is different because it directly bolsters cellular structures, potentially offering a novel way to manage diabetes beyond traditional blood sugar regulation methods.

What evidence suggests that phosphatidylserine might be an effective treatment for Type 2 Diabetes?

Research suggests that phosphatidylserine (PS) supplements, which participants in this trial may receive, might help protect against type 2 diabetes (T2D). Studies have shown that PS can enhance insulin function by altering interactions between insulin and proteins, potentially leading to better blood sugar control. Additionally, PS has been found to protect blood vessels, which is crucial for managing diabetes. Although more research is needed, these findings indicate that PS might improve blood flow and blood vessel health in people with T2D. ^{6 7 8 9 10}

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.

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?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36480277/

Phosphatidylserine in Diabetes Research

Moreover, PS supplements in food and PS-containing liposomes have been shown to protect against type 1 and type 2 diabetes (T1D and T2D, ...

2.

pubs.acs.org

pubs.acs.org/doi/abs/10.1021/acs.molpharmaceut.2c00707

Phosphatidylserine in Diabetes Research - ACS Publications

Moreover, PS supplements in food and PS-containing liposomes have been shown to protect against type 1 and type 2 diabetes (T1D and T2D, ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213231725002964

Protective effect of hydroxytyrosol against hyperglycemia ...

Hydroxytyrosol reduces phosphatidylserine exposure in erythrocytes in hyperglycemia. •. Hydroxytyrosol restores calcium homeostasis and limits PLSCR1 activity.

4.

alzdiscovery.org

alzdiscovery.org/uploads/cognitive_vitality_media/Phosphatidylserine_(supplement).pdf

Phosphatidylserine

Three of the trials focus on cognitive function and one examines the efficacy of phosphatidylserine in type 2 diabetes. NCT04920305 is a randomized, placebo ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10401552/

Concentration of Phosphatidylserine Influence Rates ...

Our group recently demonstrated that phosphatidylserine (PS) could alter the aggregation rate of insulin and lysozyme. Matveyenka and co-workers found that the ...

6.

fda.gov

fda.gov/files/food/published/GRAS-Notice-000636--Phosphatidylserine-derived-from-sunflower.pdf

Phosphatidylserine derived from Soy Lecithin

This GRAS determination is based on the data and information generally available and consented opinion about the safety of PS from a.

7.

webmd.com

webmd.com/vitamins/ai/ingredientmono-992/phosphatidylserine

Phosphatidylserine - Uses, Side Effects, and More

When taken by mouth: Phosphatidylserine is possibly safe when used for up to 3 months. Phosphatidylserine can cause side effects such as insomnia and stomach ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2966935/

Soybean-Derived Phosphatidylserine Improves Memory ...

In conclusion, Soy-PS used in this study is considered as safety food ingredient and 6 months of Soy-PS supplementation could improve the memory functions of ...

9.

my.clevelandclinic.org

my.clevelandclinic.org/health/drugs/25129-phosphatidylserine

Phosphatidylserine: What It Is, Benefits, Side Effects & Uses

But the FDA has determined that phosphatidylserine derived from fish, soy lecithin and sunflower are generally recognized as safe (GRAS). Is ...

10.

fda.gov

fda.gov/media/99092/download

GRN 643, Phosphatidylserine derived from fish

GRN 643 is a GRAS notification for phosphatidylserine (PS) derived from fish lecithin, also known as DHAPS™, which is considered safe.