ObesityNutriTechNCT01684917

Application of New Technologies and Tools to Nutrition Research

A study testing Metabolomic and Energy Intake Restriction in people with Obesity and Diabetes, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall objective of the research is to develop new methods for studying the link between diet, health and disease. Read more about this study

Who is it for?: Ages 50 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Diabetes
What is being tested?: Metabolomic and Energy Intake Restriction
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited Kingdom
Study dates: Apr 2012to Jan 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)
Age between 50-65 years

Who cannot join

Weight change of ≥ 3kg in the preceding 3 months
Current smokers
Substance abuse
Excess alcohol intake
Pregnancy
Diabetes

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College London
London, W12 0NN

Other trials in United Kingdom

About this study

The overall objective of the research is to develop new methods for studying the link between diet, health and disease.

Read the 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.

Conditions: Obesity, Diabetes
Being tested: Metabolomic and Energy Intake Restriction
Keywords: Obesity, Metabolites
Medical subject headings: Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Metabolomic and Energy Intake RestrictionBehavioural
Also called Energy restriction diet, Metabolomic
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.

Study groups in NCT01684917
Study group	Role	What they receive
Life style advice	Experimental	reduce energy intake by 20% less than estimated energy expenditure. Receives: Behavioral: Metabolomic and Energy Intake Restriction
UK background diet	Active comparator	Diet where energy intake will be matched with estimated energy expenditure. Receives: Behavioral: Metabolomic and Energy Intake Restriction
Metabolomic inquiry	Other	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. Receives: Behavioral: Metabolomic and Energy Intake Restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks

Secondary outcomes (4)

Body Composition
Body Composition assessed by BMI
Measured: Baseline, 12 weeks
Changes in Adipocyte Morphology
Percentage Change in total adipose tissue assessed by MRI
Measured: 12 weeks
Genome Integrity (DNA Methylation and Telomere Length)
Measured: 12 weeks
Body Weight
Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jan 2016

First posted13 Sep 2012 (estimated)
Study startApr 2012
Primary completionJun 2015
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01684917
Sponsor's protocol ID: 12/L0/0139
Acronym: NutriTech
Status last verified: Jan 2020
First submitted: 11 Sep 2012
Last updated: 27 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 27821717
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.
PubMed 28122782
Todt T, van Bussel I, Afmann L, Brennan L, Ivanova DG, Kiselova-Kaneva Y, Thomas EL, Ruhl R. Transcriptome-driven health status transversal-predictor analysis for health, food, microbiome, and disease markers for understanding lifestyle diseases. Physiol Genomics. 2026 Jan 1;58(1):58-70. doi: 10.1152/physiolgenomics.00026.2025. Epub 2025 Nov 19.
PubMed 41259124
Donado-Pestana CM, Rodrigues L, Rundle M, Thomas EL, Wopereis S, Gundersen TE, Trezzi JP, Bunzel D, Kiselova-Kaneva Y, Sonntag D, Kulling SE, Ivanova D, Hiller K, Drevon CA, Brennan L, Bell JD, van Ommen B, Frost G, Daniel H, Fiamoncini J. Plasma metabolomic profiles reveal sex-specific response to an oral glucose tolerance test in late middle-aged adults. Mech Ageing Dev. 2025 Aug;226:112081. doi: 10.1016/j.mad.2025.112081. Epub 2025 Jun 2.
PubMed 40467008
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.
PubMed 28794208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of New Technologies and Tools to Nutrition Research
ClinicalTrials.gov ID: NCT01684917
Acronym / sponsor ID: NutriTech / 12/L0/0139
Conditions: Obesity, Diabetes
Keywords: Obesity, Metabolites
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Study start: Apr 2012
Primary completion: Jun 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 13 Sep 2012 (estimated)
Results: Posted 27 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Life style advice	Experimental	Behavioral: Metabolomic and Energy Intake Restrictionreduce energy intake by 20% less than estimated energy expenditure.
UK background diet	Active comparator	Behavioral: Metabolomic and Energy Intake RestrictionDiet where energy intake will be matched with estimated energy expenditure.
Metabolomic inquiry	Other	Behavioral: Metabolomic and Energy Intake RestrictionThis 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.

Who may qualify

Ages: 50 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)
Age between 50-65 years

Key exclusion criteria (14 listed)

Weight change of ≥ 3kg in the preceding 3 months
Current smokers
Substance abuse
Excess alcohol intake
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Metabolomic and Energy Intake RestrictionAlso: Energy restriction diet, MetabolomicMetabolomic 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.	Behavioural	Life style advice, Metabolomic inquiry, UK background diet

Primary outcome

Insulin Sensitivity
Time frame: Baseline, 12 weeks
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
Time frame: Baseline, 12 weeks
Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the "Diet" Arm/Group.

4 secondary outcomes

Body Composition
Time frame: Baseline, 12 weeks
Changes in Adipocyte Morphology
Time frame: 12 weeks
Genome Integrity (DNA Methylation and Telomere Length)
Time frame: 12 weeks
Body Weight
Time frame: Baseline, 12 weeks

Results and safety

Results posted to the registry on 27 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exercise	11	11
Diet	7	7
Exercise, Control	13	13
Diet, Control	5	5

Primary outcome: Insulin Sensitivity

Time frame: Baseline, 12 weeks. Mean (Standard Error). Unit: mg/kg/min

Measure	Exercise n = 11	Diet n = 0	Exercise, Control n = 13	Diet, Control n = 0
Baseline	4.2 (1.8)	–	7.6 (1.6)	–
12 weeks	5.4 (1.8)	–	10.4 (2.6)	–

Exercise: p <0.05, t-test, 2 sided
Exercise, Control: p <0.05, t-test, 2 sided

Population analysed: No data available for diet and diet-control group

Primary outcome: Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol

Time frame: Baseline, 12 weeks. Mean (Standard Error). Unit: mg/dL

Measure	Exercise n = 11	Diet n = 7	Exercise, Control n = 13	Diet, Control n = 5
Baseline	5.6 (0.5)	5.6 (1.2)	5.1 (0.2)	4.9 (0.3)
12 weeks	5.8 (0.7)	4.9 (1.3)	4.9 (0.1)	5.1 (0.3)

Diet: p <0.05, t-test, 2 sided

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Diet	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Exercise, Control	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Diet, Control	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27821717Lee 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 publication: PubMed 28122782Cheung 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.
Derived from this study: PubMed 41259124Todt T, van Bussel I, Afmann L, Brennan L, Ivanova DG, Kiselova-Kaneva Y, Thomas EL, Ruhl R. Transcriptome-driven health status transversal-predictor analysis for health, food, microbiome, and disease markers for understanding lifestyle diseases. Physiol Genomics. 2026 Jan 1;58(1):58-70. doi: 10.1152/physiolgenomics.00026.2025. Epub 2025 Nov 19.
Derived from this study: PubMed 40467008Donado-Pestana CM, Rodrigues L, Rundle M, Thomas EL, Wopereis S, Gundersen TE, Trezzi JP, Bunzel D, Kiselova-Kaneva Y, Sonntag D, Kulling SE, Ivanova D, Hiller K, Drevon CA, Brennan L, Bell JD, van Ommen B, Frost G, Daniel H, Fiamoncini J. Plasma metabolomic profiles reveal sex-specific response to an oral glucose tolerance test in late middle-aged adults. Mech Ageing Dev. 2025 Aug;226:112081. doi: 10.1016/j.mad.2025.112081. Epub 2025 Jun 2.
Derived from this study: PubMed 28794208Yin 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gary S Frost principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Metabolomic and Energy Intake Restriction in people with Obesity and Diabetes, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin Sensitivity (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01684917, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.