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| Tracking Information | |||||
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| First Received Date ICMJE | August 30, 2005 | ||||
| Last Updated Date | February 12, 2009 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00140816 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Dairy Products and Metabolic Effects (Norwegian Part) | ||||
| Official Title ICMJE | Dairy Products and Metabolic Effects - A Multicentre Nordic Study | ||||
| Brief Summary | Foods containing more dairy fat (and thus a higher proportion of short and medium chain fatty acids and possibly some other nutrients or micronutrients with effect on energy intake, satiety or energy metabolism) affect energy balance and metabolic profile in subjects prone to develop abdominal adiposity and metabolic syndrome. The aim of the study is to test the hypothesis that intake of dairy products has a favorable effect on markers of the metabolic syndrome. To explore such a hypothesis the participants have to be in a free living situation during an extended study period. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Increased intake of dairy products | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Apparently healthy men and women aged 30-65 years with:
Exclusion Criteria: Patients with any of the following conditions will not be included in the trial:
Concomitant medications:
Associated diseases or conditions:
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| Gender | Both | ||||
| Ages | 30 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00140816 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | Melk61015 | ||||
| Study Sponsor ICMJE | Rikshospitalet HF | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Rikshospitalet HF | ||||
| Verification Date | February 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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