An interventional study of L-serine in Serine, sponsored by Massachusetts General Hospital. Withdrawn. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-16.
Sponsored by Massachusetts General Hospital · Not applicable and Interventional
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.
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.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomized participants will take 6g daily of dietary serine supplement
Dietary Supplement: L-serine
Randomized participants will take 12g daily of dietary serine supplement
Dietary Supplement: L-serine
Randomized participants will take 24g daily of dietary serine supplement
Dietary Supplement: L-serine
Randomized participants will take 48g daily of dietary serine supplement
Dietary Supplement: L-serine
Participants will take dietary serine supplementation daily
Circulating serine levels
We will measure circulating serine levels after 14 days of intervention
Time frame: 14 days
Supplement tolerability
We will assess tolerability of dietary serine supplements after 14 days of intervention
Time frame: 14 days
Fasting and post-prandial glucose
We will assess fasting and post-prandial glucose after 14 days of intervention
Time frame: 14 days
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital