Flax Mucilage and Apparent Nutrient Digestibility (HØRFRØ)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Copenhagen.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Copenhagen
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00953004
First received: July 17, 2009
Last updated: November 10, 2010
Last verified: August 2009
| Tracking Information | |||||
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| First Received Date ICMJE | July 17, 2009 | ||||
| Last Updated Date | November 10, 2010 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Fat and energy digestibility [ Time Frame: mean over period ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00953004 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Flax Mucilage and Apparent Nutrient Digestibility | ||||
| Official Title ICMJE | Effect of Flaxseed and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite | ||||
| Brief Summary | The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults. |
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| Detailed Description | A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Dietary Supplement: fiber drink and fiber bread
fiber drink or fiber bread three times daily |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 16 | ||||
| Estimated Completion Date | December 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00953004 | ||||
| Other Study ID Numbers ICMJE | B245 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Head and professor Arne Astrup, University of Copenhagen, Department of Human Nutrition | ||||
| Study Sponsor ICMJE | University of Copenhagen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Copenhagen | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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