Short Term Dietary Serine Supplementation and Circulating Serine Levels
- Conditions
- Serine
- Interventions
- Dietary Supplement: L-serine
- Registration Number
- NCT02528994
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- risk factors for type 2 diabetes
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serine 48g daily L-serine Randomized participants will take 48g daily of dietary serine supplement Serine 6g daily L-serine Randomized participants will take 6g daily of dietary serine supplement Serine 12g daily L-serine Randomized participants will take 12g daily of dietary serine supplement Serine 24g daily L-serine Randomized participants will take 24g daily of dietary serine supplement
- Primary Outcome Measures
Name Time Method Circulating serine levels 14 days We will measure circulating serine levels after 14 days of intervention
- Secondary Outcome Measures
Name Time Method Supplement tolerability 14 days We will assess tolerability of dietary serine supplements after 14 days of intervention
Fasting and post-prandial glucose 14 days We will assess fasting and post-prandial glucose after 14 days of intervention