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OpenTrials
Completed

NCT Number: NCT00213551

Glutamine and Intestinal Protein Metabolism

Gut barrier plays a major role in defence of the organism. During catabolic states, like major surgery or inflammation, gut barrier could be altered. It has been reported that preoperative nutritional support may have beneficial effects on clinical outcome in patients with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino, have been reported to modulate inflammatory, antioxidant responses and protein metabolism in intestine. In addition, glutamine supply improves clinical outcome in critically ill patients. Antioxidant micronutrients may also have some beneficial effects in intestine by improving antioxidant response and might also regulate protein expression. Nevertheless, effects of glutamine combined to antioxidant micronutrients have not been evaluated.

Thus, the aim of this study will be to assess the influence of glutamine and glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital of Rouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers, male and female, aged between 18 and 50 years, negatives for HIV1, 2 and for HVC and HVB
  • BMI between 20 and 24 kg/m²,
  • giving their written informed consent
  • no-smokers
  • no allergic and digestive antecedents

Exclusion criteria

  • smokers
  • Allergic and digestive antecedents,
  • pregnancy

Treatment and study plan

glutamine

Drug

Glucose

Drug

glutamine-antioxidants containing solution

Drug

Primary outcomes

  1. Impact on protein synthesis rate and proteolytic activities in intestine.

    Time frame: at the end of infusion (hour 5)

Secondary outcomes

  1. Comparison of protein expression pattern and glutathione synthesis.

    Time frame: at the end of infusion (hour 5)

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Comparative Effects of Glutamine and Glucose on Intestinal Protein Metabolism in Healthy Humans

Important dates

Study start
2004
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Jun 18, 2013

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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