NCT00953602

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 25, 2009

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

August 5, 2009

Last Update Submit

August 24, 2009

Conditions

Glucose MetabolismHormonal ChangesSatiety

Outcome Measures

Primary Outcomes (1)

  • glucose metabolism

    1 week

Interventions

Genetically modified potatoOTHER

Genetically modified potato

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male volunteers

You may not qualify if:

  • acute oder severe chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité, Dpt. of Endocrinology, Diabetes and Nutrition

Berlin, State of Berlin, 12200, Germany

RECRUITING

Central Study Contacts

Jaochim Spranger, MD

CONTACT

0049308445joachim.spranger@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 25, 2009

Record last verified: 2009-08

Locations

DE(1)