Short Term Dietary Serine Supplementation and Circulating Serine Levels
NCT ID: NCT02528994
Last Updated: 2016-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-09-30
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Serine 6g daily
Randomized participants will take 6g daily of dietary serine supplement
L-serine
Participants will take dietary serine supplementation daily
Serine 12g daily
Randomized participants will take 12g daily of dietary serine supplement
L-serine
Participants will take dietary serine supplementation daily
Serine 24g daily
Randomized participants will take 24g daily of dietary serine supplement
L-serine
Participants will take dietary serine supplementation daily
Serine 48g daily
Randomized participants will take 48g daily of dietary serine supplement
L-serine
Participants will take dietary serine supplementation daily
Interventions
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L-serine
Participants will take dietary serine supplementation daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Geoffrey Walford, MD
Physician
Principal Investigators
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Geoffrey A Walford, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Other Identifiers
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2014D001170
Identifier Type: -
Identifier Source: org_study_id
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