Study Stopped
The PI will be leaving the institution and not continuing the study
Short Term Dietary Serine Supplementation and Circulating Serine Levels
A Pilot Study to Test the Effect of Short Term Dietary Serine Supplementation on Circulating Serine Levels
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 16, 2016
September 1, 2016
Same day
August 18, 2015
September 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Circulating serine levels
We will measure circulating serine levels after 14 days of intervention
14 days
Secondary Outcomes (2)
Supplement tolerability
14 days
Fasting and post-prandial glucose
14 days
Study Arms (4)
Serine 6g daily
EXPERIMENTALRandomized participants will take 6g daily of dietary serine supplement
Serine 12g daily
EXPERIMENTALRandomized participants will take 12g daily of dietary serine supplement
Serine 24g daily
EXPERIMENTALRandomized participants will take 24g daily of dietary serine supplement
Serine 48g daily
EXPERIMENTALRandomized participants will take 48g daily of dietary serine supplement
Interventions
Participants will take dietary serine supplementation daily
Eligibility Criteria
You may qualify if:
- risk factors for type 2 diabetes
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey A Walford, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
August 18, 2015
First Posted
August 19, 2015
Study Start
September 1, 2016
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
September 16, 2016
Record last verified: 2016-09