Application of New Technologies and Tools to Nutrition Research (NutriTech)

Tracking Information
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; (submitted: October 26, 2016)	Insulin sensitivity [ Time Frame: 12 weeks ]; Metabolomic biomarker discovery [ Time Frame: 3 day ]
Original Primary Outcome Measures ICMJE; (submitted: September 11, 2012)	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; (submitted: September 11, 2012)	Body weight and composition [ Time Frame: 12 weeks ]; Adipocyte morphology, differentiation and signalling [ Time Frame: 12 weeks ]; Genome integrity (DNA methylation and telomere length) [ Time Frame: 12 weeks ]
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.
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
Condition ICMJE	Obesity; Diabetes
Intervention ICMJE	Behavioral: Metabolomic and Energy Intake Restriction; Metabolomic inquiry followed by a 12 week energy intake restriction; Other Names: Energy restriction diet; Metabolomic
Study Arms	Experimental: Life style advice reduce energy intake by 20% less than estimated energy expenditure. Intervention: Behavioral: Metabolomic and Energy Intake Restriction; Active Comparator: UK background diet Diet where energy intake will be matched with estimated energy expenditure. Intervention: Behavioral: Metabolomic and Energy Intake Restriction; Metabolomic inquiry This inquiry took place prior to the randomized controlled trial and include 50 volunteers who will then be asked to volunteers of the weight loss study. Were randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option. Intervention: Behavioral: Metabolomic and Energy Intake Restriction
Publications *	Yin X, Gibbons H, Rundle M, Frost G, McNulty BA, Nugent AP, Walton J, Flynn A, Gibney MJ, Brennan L. Estimation of Chicken Intake by Adults Using Metabolomics-Derived Markers. J Nutr. 2017 Aug 9. pii: jn252197. doi: 10.3945/jn.117.252197. [Epub ahead of print]; Cheung W, Keski-Rahkonen P, Assi N, Ferrari P, Freisling H, Rinaldi S, Slimani N, Zamora-Ros R, Rundle M, Frost G, Gibbons H, Carr E, Brennan L, Cross AJ, Pala V, Panico S, Sacerdote C, Palli D, Tumino R, Kühn T, Kaaks R, Boeing H, Floegel A, Mancini F, Boutron-Ruault MC, Baglietto L, Trichopoulou A, Naska A, Orfanos P, Scalbert A. A metabolomic study of biomarkers of meat and fish intake. Am J Clin Nutr. 2017 Mar;105(3):600-608. doi: 10.3945/ajcn.116.146639. Epub 2017 Jan 25.
* 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
Actual Enrollment ICMJE; (submitted: October 26, 2016)	74
Original Estimated Enrollment ICMJE; (submitted: September 11, 2012)	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: Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2); Age between 50-65 years Exclusion Criteria: Weight change of ≥ 3kg in the preceding 3 months; Current smokers; Substance abuse; Excess alcohol intake; Pregnancy; Diabetes; Cardiovascular disease; Cancer; Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome; Kidney disease; Liver disease; Pancreatitis; Have any metallic or magnetic implants such as pacemakers; Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Gary S Frost Imperial College London
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