Metabolic Changes Induced by Genetically Modified Potatoes

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00953966
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 7
• Duration (Months): 30
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glucose Metabolism; Endocrine Metabolism; Satiety	Other: Genetically modified potatoes	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Starch 1 Starch 1	Other: Genetically modified potatoes; Starch from genetically modified potatoes
Other: Starch 2 Starch 2	Other: Genetically modified potatoes; Starch from genetically modified potatoes
Other: Starch 3 Starch 3	Other: Genetically modified potatoes; Starch from genetically modified potatoes
Other: Starch 4 Starch 4	Other: Genetically modified potatoes; Starch from genetically modified potatoes
Other: Starch 5 Starch 5	Other: Genetically modified potatoes; Starch from genetically modified potatoes
Other: Starch 6 Starch 6	Other: Genetically modified potatoes; Starch from genetically modified potatoes
Other: Starch 7 Starch 7	Other: Genetically modified potatoes; Starch from genetically modified potatoes

Outcome Measures

Primary Outcome Measures

1. Glucose metabolism [2 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy males

Exclusion Criteria:

• no acute oder severe chronic diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité, Dept. of Endocrinology, Diabetes and Nutrition	Berlin		Germany	12200

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00953966
• Other Study ID Numbers: EA4/069/07
• First Posted: Aug 6, 2009
• Last Update Posted: Aug 25, 2009
• Last Verified: Aug 1, 2009

Study Results

No Results Posted as of Aug 25, 2009