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

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.

Study Overview

• Status: Withdrawn
• Conditions: Serine
• Intervention / Treatment: Dietary supplement: L-serine

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Serine 6g daily; Randomized participants will take 6g daily of dietary serine supplement	Dietary supplement: L-serine; Participants will take dietary serine supplementation daily
Experimental: Serine 12g daily; Randomized participants will take 12g daily of dietary serine supplement	Dietary supplement: L-serine; Participants will take dietary serine supplementation daily
Experimental: Serine 24g daily; Randomized participants will take 24g daily of dietary serine supplement	Dietary supplement: L-serine; Participants will take dietary serine supplementation daily
Experimental: Serine 48g daily; Randomized participants will take 48g daily of dietary serine supplement	Dietary supplement: L-serine; Participants will take dietary serine supplementation daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating serine levels	We will measure circulating serine levels after 14 days of intervention	14 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Geoffrey A Walford, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Metabolism; Dietary supplements
• Other Study ID Numbers: 2014D001170