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Metabolic Changes Induced by Genetically Modified Potatoes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00953966
First received: August 5, 2009
Last updated: August 24, 2009
Last verified: August 2009
  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 Blind (Subject)
Primary Purpose: Basic Science

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

Primary Outcome Measures:
  • Glucose metabolism [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males

Exclusion Criteria:

  • no acute oder severe chronic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor J. Spranger, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00953966     History of Changes
Other Study ID Numbers: EA4/069/07
Study First Received: August 5, 2009
Last Updated: August 24, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on November 25, 2014