Short Term Dietary Serine Supplementation and Circulating Serine Levels

Not Applicable

Withdrawn

• Conditions: 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.

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Status Verified: 2016-09
• Study Start: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
Fasting and post-prandial glucose	14 days	We will assess fasting and post-prandial glucose after 14 days of intervention
Supplement tolerability	14 days	We will assess tolerability of dietary serine supplements after 14 days of intervention