SmokingNCT00662766
Intervention With Black Currant Seed Press Residues in Healthy Subjects
A study testing black currant seed press residue, Bread without black currant seed press residues and Baseline data in people with Smoking, run by University of Jena.
Trial summary
The study was performed to investigate the effects of the consumption of black currant seed press residues, which were baked into bread. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Smoking
- What is being tested?
- black currant seed press residue, Bread without black currant seed press residues and Baseline data
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- discrimination between smoker (> 5 cigarets/d) or non-smoker
Who cannot join
- diet during the study
- serious sport
- diagnosed diseases
- use of nutritional supplements
About this study
Official title: Intervention Study on the Health Beneficial Effects of Bread Enriched With Black Currant Seed Press Residues in Healthy Subjects
The study was performed to investigate the effects of the consumption of black currant seed press residues, which were baked into bread.
Read the 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.
- Conditions
- Smoking
- Being tested
- black currant seed press residue, Bread without black currant seed press residues, Baseline data
- Keywords
- Black currant, Berry seed, Press residue, Tocopherol, Fatty acids, Fiber, Total phenols, TEAC, Comet assay, Dihydroxybenzoic acid
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
black currant seed press residueDietary supplement
Black currant seed press residue, baked into bread
Bread without black currant seed press residuesDietary supplement
Same bread but without seeds
Baseline dataDietary supplement
No supplement was administered.
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidant/antioxidant status of the test person
Measured: after 1, 5, and 9 weeks
Secondary outcomes (2)
tocopherol intake, tocopherol faecal excretion and serum tocopherol concentration
Measured: after 1, 5, and 9 weeks
fiber intake and excretion
Measured: after 1, 5, and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startSep 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Gerhard Jahreis, Prof. Dr., Study chair, University of Jena, Dept. of Nutritional PhysiologyDorit Helbig, Dipl. troph., Principal investigator, University of Jena, Dept. of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662766
- Sponsor's protocol ID
- LSEP H22-05
- Status last verified
- Apr 2008
- First submitted
- 10 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.clnu.2009.05.003. Epub 2009 Jun 11.
PubMed 19523725
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study on the Health Beneficial Effects of Bread Enriched With Black Currant Seed Press Residues in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00662766
- Acronym / sponsor ID
- LSEP H22-05
- Conditions
- Smoking
- Keywords
- Black currant, Berry seed, Press residue, Tocopherol, Fatty acids, Fiber, Total phenols, TEAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- discrimination between smoker (> 5 cigarets/d) or non-smoker
Key exclusion criteria (4 listed)
- diet during the study
- serious sport
- diagnosed diseases
- use of nutritional supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| black currant seed press residueBlack currant seed press residue, baked into bread | Dietary supplement | – |
| Bread without black currant seed press residuesSame bread but without seeds | Dietary supplement | – |
| Baseline dataNo supplement was administered. | Dietary supplement | – |
Primary outcome
oxidant/antioxidant status of the test person
Time frame: after 1, 5, and 9 weeks
2 secondary outcomes
tocopherol intake, tocopherol faecal excretion and serum tocopherol concentration
Time frame: after 1, 5, and 9 weeks
fiber intake and excretion
Time frame: after 1, 5, and 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
- Derived from this study: PubMed 19523725Helbig 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. doi: 10.1016/j.clnu.2009.05.003. Epub 2009 Jun 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Jahreis, Prof. Dr. study chair
University of Jena, Dept. of Nutritional Physiology
Dorit Helbig, Dipl. troph. principal investigator
University of Jena, Dept. of Nutritional Physiology
Questions about this trial
What is this clinical trial studying?
A study testing black currant seed press residue, Bread without black currant seed press residues and Baseline data in people with Smoking, run by University of Jena.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxidant/antioxidant status of the test person (time frame: after 1, 5, and 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00662766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2008.