Long Time 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:
NCT00953602
First received: August 5, 2009
Last updated: August 24, 2009
Last verified: August 2009
  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 Blind (Subject)
Primary Purpose: Basic Science

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

Primary Outcome Measures:
  • glucose metabolism [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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

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

Inclusion Criteria:

  • healthy male volunteers

Exclusion Criteria:

  • acute oder severe chronic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor J. Spranger, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00953602     History of Changes
Other Study ID Numbers: EA4/011/09
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 April 16, 2014