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Completed

NCT Number: NCT02184832

Dietary Intake of Tryptophan and Metformin Response

This study will examine the influence of dietary intake of tryptophan on response to metformin. The investigators hypothesize that dietary tryptophan alteration will influence metformin response.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adult male or non-pregnant female volunteers (age 20-40)
  • able and willing to give consent

Exclusion criteria

  • Age less than 20 or greater than 40
  • Women who are pregnant, nursing, or at risk of becoming pregnant
  • Body mass index (BMI) less than 20 or greater than 28
  • Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
  • Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study
  • Known diabetes or pre-diabetes (based on prior diagnoses, use of medications to lower glucose; or fasting blood glucose > 100mg/dL at screening)
  • Untreated hypertension (defined as systolic blood pressure > 140mmHg and diastolic blood pressure > 90mmHg)
  • Current or past mood disorder, including major depression, anxiety, or bipolar disorder
  • Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
  • History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
  • Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
  • Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
  • Use of medications and herbal or vitamin supplements during the study
  • Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
  • Objection to taking metformin
  • Participation in any other interventional study during the study duration
  • Use of nicotine-containing products, including inhaled, chewed, or patches during the study.
  • Use of drugs of abuse.
  • Restrictions that prevent adherence to standardized meals or unwillingness to adhere to a pre-specified meal plan, including abstinence from alcohol and limitation of caffeine intake to one drink daily.

Treatment and study plan

metformin

Drug

2 doses of 500 mg metformin given approximately 12 hrs apart

Low tryptophan diet

Other

High tryptophan diet

Other

Primary outcomes

  1. change in fasting glucose

    Time frame: 2 days

Secondary outcomes

  1. change in tryptophan concentration

    Time frame: 2 days

Other outcomes

  1. tolerability of dietary tryptophan alteration

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2014
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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