Short Term Dietary Serine Supplementation and Circulating Serine Levels

Study Overview
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Brief Summary
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This study will test the effect of short-term, high-dose dietary serine supplementation on circulating levels of serine. Individuals with risk factors for type 2 diabetes will be recruited into the 2 week study. Effects of dietary serine supplementation on glycemic measures will also be explored.

Detailed Description
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This is a single-center, open-label, randomized, nutritional intervention study in adults. Subjects will have three visits to the Massachusetts General Hospital Clinical Research Center (CRC) during the 2 week study. At the first study visit (Visit 1), the following will occur: informed consent; medical and nutritional history assessment; blood pressure, weight and height, fasting blood draw and blood work during a 2 hr oral glucose tolerance test; explanation and instructions for completion of a 4-day food log; randomized assignment to dose of dietary serine supplementation (6g, 12g, 24g, or 48g); provide 7 days of dietary serine supplements; take first dose of supplement with snack; schedule Visit 2 and Visit 3. Between Visit 1 and Visit 2, participants will complete the Food Log and take the assigned dose of dietary serine supplementation 3 times daily. Visit 2 will occur 7 days after Visit 1. Subjects will not take dietary serine supplementation prior to Visit 2 activities. At Visit 2, the following will occur: weight and blood pressure; fasting blood draw; administration of assigned dose of dietary serine supplementation with snack after blood work; review of the 4-day food log; provide 7 days of dietary serine supplements completion of anonymous survey to assess tolerability of supplement. Participants will continue to take the assigned dose of dietary serine supplementation 3 times daily between Visit 2 and Visit 3. Visit 3 will occur 7 days after Visit 2. At Visit 3, the following will occur: weight and blood pressure; review of the 4-day food log; fasting blood draw and blood work during a 2 hr oral glucose tolerance test; completion of study survey to assess tolerability of the supplement.

Official Title
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A Pilot Study to Test the Effect of Short Term Dietary Serine Supplementation on Circulating Serine Levels

Conditions
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Serine

Intervention / Treatment
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* Dietary Supplement: L-serine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: risk factors for type 2 diabetes Exclusion Criteria: known type 2 diabetes women who are pregnant, nursing, or not using contraception or abstinence taking amino acid supplements during the study or at any time 1 month prior to enrollment in the study conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery known active liver disease currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones participation in any other interventional study during the study duration inability to adhere to study protocol.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serine 6g daily<br>Randomized participants will take 6g daily of dietary serine supplement | Dietary Supplement: L-serine<br>* Participants will take dietary serine supplementation daily<br>|
| Experimental: Serine 12g daily<br>Randomized participants will take 12g daily of dietary serine supplement | Dietary Supplement: L-serine<br>* Participants will take dietary serine supplementation daily<br>|
| Experimental: Serine 24g daily<br>Randomized participants will take 24g daily of dietary serine supplement | Dietary Supplement: L-serine<br>* Participants will take dietary serine supplementation daily<br>|
| Experimental: Serine 48g daily<br>Randomized participants will take 48g daily of dietary serine supplement | Dietary Supplement: L-serine<br>* Participants will take dietary serine supplementation daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating serine levels | We will measure circulating serine levels after 14 days of intervention | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supplement tolerability | We will assess tolerability of dietary serine supplements after 14 days of intervention | 14 days | 
| Fasting and post-prandial glucose | We will assess fasting and post-prandial glucose after 14 days of intervention | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary supplements, Metabolism