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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:
NCT00953966
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
Starches from genetically modified potatoes, which differed in terms of amylose, amylopectin and phosphate content, were tested in a human randomized controlled trial.

Condition Intervention
Glucose Metabolism Endocrine Metabolism Satiety Other: Genetically modified potatoes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group 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: 2 days ]

Estimated Enrollment: 50
Study Start Date: June 2007
Estimated Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Starch 1
Starch 1
Other: Genetically modified potatoes
Starch from genetically modified potatoes
Starch 2
Starch 2
Other: Genetically modified potatoes
Starch from genetically modified potatoes
Starch 3
Starch 3
Other: Genetically modified potatoes
Starch from genetically modified potatoes
Starch 4
Starch 4
Other: Genetically modified potatoes
Starch from genetically modified potatoes
Starch 5
Starch 5
Other: Genetically modified potatoes
Starch from genetically modified potatoes
Starch 6
Starch 6
Other: Genetically modified potatoes
Starch from genetically modified potatoes
Starch 7
Starch 7
Other: Genetically modified potatoes
Starch from genetically modified potatoes

  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 males

Exclusion Criteria:

  • no 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): NCT00953966


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

Locations
Germany
Charité, Dept. 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: NCT00953966     History of Changes
Other Study ID Numbers: EA4/069/07
First Submitted: August 5, 2009
First Posted: August 6, 2009
Last Update Posted: August 25, 2009
Last Verified: August 2009