Intervention With Black Currant Seed Press Residues in Healthy Subjects
This study has been completed.
Sponsor:
University of Jena
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00662766
First received: April 10, 2008
Last updated: April 16, 2008
Last verified: April 2008
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 10, 2008 | ||||||||
| Last Updated Date | April 16, 2008 | ||||||||
| Start Date ICMJE | September 2005 | ||||||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
oxidant/antioxidant status of the test person [ Time Frame: after 1, 5, and 9 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00662766 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intervention With Black Currant Seed Press Residues in Healthy Subjects | ||||||||
| Official Title ICMJE | Intervention Study on the Health Beneficial Effects of Bread Enriched With Black Currant Seed Press Residues in Healthy Subjects | ||||||||
| Brief Summary | The study was performed to investigate the effects of the consumption of black currant seed press residues, which were baked into bread. |
||||||||
| Detailed Description | Berry seeds are a by-product of berry fabrication (e. g. to juices or jam). In order to maintain their functionality and long life span, berry seeds need to contain cell stabilizing ingredients such as vitamins and polyphenols. Since it seems to be a valuable source of health beneficial substances in human nutrition, commercial use should be found. Therefore, seeds were pressed (seed press residue), ground and baked into bread for consumption. Black currant seed press residues are rich in tocopherols and also contain anthocyanins; both act as antioxidants. Additionally there is 50% fibre in the residue, soluble and insoluble fibre in equal shares. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE | Smoking | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Helbig D, Wagner A, Schubert R, Jahreis G. Tocopherol isomer pattern in serum and stool of human following consumption of black currant seed press residue administered in whole grain bread. Clin Nutr. 2009 Dec;28(6):662-7. Epub 2009 Jun 11. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 36 | ||||||||
| Completion Date | December 2005 | ||||||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | 18 Years to 35 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00662766 | ||||||||
| Other Study ID Numbers ICMJE | LSEP H22-05 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Prof. Dr. G. Jahreis, Universitiy of Jena | ||||||||
| Study Sponsor ICMJE | University of Jena | ||||||||
| Collaborators ICMJE | German Federal Ministry of Education and Research | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of Jena | ||||||||
| Verification Date | April 2008 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||