Clinical trial NCT02528994: Short Term Dietary Serine Supplementation and Circulating Serine Levels
Official title: A Pilot Study to Test the Effect of Short Term Dietary Serine Supplementation on Circulating Serine Levels
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Serine
Keywords: Dietary supplements
Metabolism
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Circulating serine levels
timeFrame: 14 days
Secondary outcomes:
measure: Supplement tolerability
timeFrame: 14 days
measure: Fasting and post-prandial glucose
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Geoffrey A Walford, MD
role: PRINCIPAL_INVESTIGATOR
References: