Application of New Technologies and Tools to Nutrition Research (NutriTech)
Primary Purpose
Obesity, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Metabolomic and Energy Intake Restriction
Sponsored by

About this trial
This is an interventional diagnostic trial for Obesity focused on measuring Obesity, Metabolites
Eligibility Criteria
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.
Sites / Locations
- Imperial College London
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Life style advice
UK background diet
Metabolomic inquiry
Arm Description
reduce energy intake by 20% less than estimated energy expenditure.
Diet where energy intake will be matched with estimated energy expenditure.
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.
Outcomes
Primary Outcome Measures
Insulin Sensitivity
Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the "Exercise" and "Exercise, Control" groups. No data were collected for this Outcome from the remaining groups.
Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the "Diet" Arm/Group.
Secondary Outcome Measures
Body Composition
Body Composition assessed by BMI
Changes in Adipocyte Morphology
Percentage Change in total adipose tissue assessed by MRI
Genome Integrity (DNA Methylation and Telomere Length)
Body Weight
Full Information
NCT ID
NCT01684917
First Posted
September 11, 2012
Last Updated
January 13, 2020
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT01684917
Brief Title
Application of New Technologies and Tools to Nutrition Research
Acronym
NutriTech
Official Title
Application of New Technologies and Tools to Nutrition Research
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall objective of the research is to develop new methods for studying the link between diet, health and disease.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes
Keywords
Obesity, Metabolites
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Life style advice
Arm Type
Experimental
Arm Description
reduce energy intake by 20% less than estimated energy expenditure.
Arm Title
UK background diet
Arm Type
Active Comparator
Arm Description
Diet where energy intake will be matched with estimated energy expenditure.
Arm Title
Metabolomic inquiry
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Metabolomic and Energy Intake Restriction
Other Intervention Name(s)
Energy restriction diet, Metabolomic
Intervention Description
Metabolomic inquiry followed by a 12 week energy intake restriction. This study is part of a very large European study called EPIC. Only the results by Lee et al. 2016 have been presented here. The results of the study published by Cheung 2017 are from a different study. therefore the entries for the results are correct. For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option. In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately. Unfortunately no different NCT number is available.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the "Exercise" and "Exercise, Control" groups. No data were collected for this Outcome from the remaining groups.
Time Frame
Baseline, 12 weeks
Title
Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
Description
Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the "Diet" Arm/Group.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Body Composition
Description
Body Composition assessed by BMI
Time Frame
Baseline, 12 weeks
Title
Changes in Adipocyte Morphology
Description
Percentage Change in total adipose tissue assessed by MRI
Time Frame
12 weeks
Title
Genome Integrity (DNA Methylation and Telomere Length)
Time Frame
12 weeks
Title
Body Weight
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary S Frost
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27821717
Citation
Lee S, Norheim F, Langleite TM, Noreng HJ, Storas TH, Afman LA, Frost G, Bell JD, Thomas EL, Kolnes KJ, Tangen DS, Stadheim HK, Gilfillan GD, Gulseth HL, Birkeland KI, Jensen J, Drevon CA, Holen T; NutriTech Consortium. Effect of energy restriction and physical exercise intervention on phenotypic flexibility as examined by transcriptomics analyses of mRNA from adipose tissue and whole body magnetic resonance imaging. Physiol Rep. 2016 Nov;4(21):e13019. doi: 10.14814/phy2.13019.
Results Reference
result
PubMed Identifier
28122782
Citation
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, Kuhn 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.
Results Reference
result
PubMed Identifier
28794208
Citation
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 Oct 1;147(10):1850-1857. doi: 10.3945/jn.117.252197.
Results Reference
derived
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Application of New Technologies and Tools to Nutrition Research
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