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Short Term Dietary Serine Supplementation and Circulating Serine Levels

This study has been withdrawn prior to enrollment.
(The PI will be leaving the institution and not continuing the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02528994
First Posted: August 19, 2015
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Geoffrey Walford, MD, Massachusetts General Hospital
  Purpose
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.

Condition Intervention
Serine Dietary Supplement: L-serine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Pilot Study to Test the Effect of Short Term Dietary Serine Supplementation on Circulating Serine Levels

Resource links provided by NLM:


Further study details as provided by Geoffrey Walford, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Circulating serine levels [ Time Frame: 14 days ]
    We will measure circulating serine levels after 14 days of intervention


Secondary Outcome Measures:
  • Supplement tolerability [ Time Frame: 14 days ]
    We will assess tolerability of dietary serine supplements after 14 days of intervention

  • Fasting and post-prandial glucose [ Time Frame: 14 days ]
    We will assess fasting and post-prandial glucose after 14 days of intervention


Enrollment: 0
Study Start Date: September 2016
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528994


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Geoffrey A Walford, MD Massachusetts General Hospital
  More Information

Responsible Party: Geoffrey Walford, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02528994     History of Changes
Other Study ID Numbers: 2014D001170
First Submitted: August 18, 2015
First Posted: August 19, 2015
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by Geoffrey Walford, MD, Massachusetts General Hospital:
Dietary supplements
Metabolism