NCT00953966

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.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration 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

June 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month 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

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

2.1 years

First QC Date

August 5, 2009

Last Update Submit

August 24, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glucose metabolism

    2 days

Study Arms (7)

Starch 1

OTHER

Starch 1

Other: Genetically modified potatoes

Starch 2

OTHER

Starch 2

Other: Genetically modified potatoes

Starch 3

OTHER

Starch 3

Other: Genetically modified potatoes

Starch 4

OTHER

Starch 4

Other: Genetically modified potatoes

Starch 5

OTHER

Starch 5

Other: Genetically modified potatoes

Starch 6

OTHER

Starch 6

Other: Genetically modified potatoes

Starch 7

OTHER

Starch 7

Other: Genetically modified potatoes

Interventions

Starch from genetically modified potatoes

Starch 1Starch 2Starch 3Starch 4Starch 5Starch 6Starch 7

Eligibility Criteria

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

You may qualify if:

  • healthy males

You may not qualify if:

  • no acute oder severe chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité, Dept. of Endocrinology, Diabetes and Nutrition

Berlin, State of Berlin, 12200, Germany

RECRUITING

Central Study Contacts

Joachim Spranger, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

June 1, 2007

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

August 25, 2009

Record last verified: 2009-08

Locations