Application of New Technologies and Tools to Nutrition Research (NutriTech)
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ClinicalTrials.gov Identifier: NCT01684917 |
Recruitment Status
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Completed
First Posted
: September 13, 2012
Last Update Posted
: October 27, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | September 11, 2012 | |||
First Posted Date ICMJE | September 13, 2012 | |||
Last Update Posted Date | October 27, 2016 | |||
Study Start Date ICMJE | April 2012 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Insulin sensitivity [ Time Frame: 12 weeks ] | |||
Change History | Complete list of historical versions of study NCT01684917 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 | Application of New Technologies and Tools to Nutrition Research | |||
Official Title ICMJE | Application of New Technologies and Tools to Nutrition Research | |||
Brief Summary | The overall objective of the research is to develop new methods for studying the link between diet, health and disease. The enquiry consists of two part. A metabolomic biomarker discovery study followed by a randomised controlled trial of moderate dietary induced weight loss. A cohort of moderately overweight men and women will undergo a metabolomic study follow by randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week period. This intervention will improve the volunteer's body composition and reduce their risk of developing diabetes. Extensive tests will be conducted before and after the dietary intervention using emerging technologies with current state-of-the-art methods. These tests will monitor the numerous physiological adaptations that have occurred on a gene, cell, organ and organismic level. The study will, therefore, aim for a scientific breakthrough by developing a series of novel biological "markers" that can accurately determine an individual's health status. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Metabolomic and Energy Intake Restriction
Metabolomic inquiry followed by a 12 week energy intake restriction
Other Names:
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Study Arms |
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Publications * |
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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 | Completed | |||
Actual Enrollment ICMJE |
74 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Actual Study Completion Date | January 2016 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01684917 | |||
Other Study ID Numbers ICMJE | 12/L0/0139 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Imperial College London | |||
Study Sponsor ICMJE | Imperial College London | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Imperial College London | |||
Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |