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Long Time Metabolic Changes Induced by Genetically Modified Potatoes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953602
First Posted: August 6, 2009
Last Update Posted: August 25, 2009
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:
Charite University, Berlin, Germany
  Purpose
In this study the effects of genetically modified potatoes on the human metabolism will be observed. Healthy volunteers receive for one week muffins, produced with starch from a genetically modified potato or with a normal available starch, in a randomized trial.

Condition Intervention
Glucose Metabolism Hormonal Changes Satiety Other: Genetically modified potato

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • glucose metabolism [ Time Frame: 1 week ]

Estimated Enrollment: 20
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Genetically modified potato
    Genetically modified potato
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male volunteers

Exclusion Criteria:

  • acute oder severe chronic diseases
  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): NCT00953602


Contacts
Contact: Jaochim Spranger, MD 0049308445 ext 2114 joachim.spranger@charite.de

Locations
Germany
Charité, Dpt. of Endocrinology, Diabetes and Nutrition Recruiting
Berlin, Germany, 12200
Contact: Joachim Spranger, MD    0049308445 ext 2114    joachim.spranger@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

Responsible Party: Professor J. Spranger, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00953602     History of Changes
Other Study ID Numbers: EA4/011/09
First Submitted: August 5, 2009
First Posted: August 6, 2009
Last Update Posted: August 25, 2009
Last Verified: August 2009