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

History of Changes

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:

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 May 22, 2013

To Top