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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Life style advice | Experimental | reduce energy intake by 20% less than estimated energy expenditure. |
|
| UK background diet | Active Comparator | Diet where energy intake will be matched with estimated energy expenditure. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metabolomic and Energy Intake Restriction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | Body Composition assessed by BMI | Baseline, 12 weeks |
| Changes in Adipocyte Morphology | Percentage Change in total adipose tissue assessed by MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary S Frost | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27821717 | Result | 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. | |
| 28122782 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks |
| FG001 | Diet | overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks. Energy intake was matched with estimated energy expenditure |
| FG002 | Exercise, Control | An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks |
| FG003 | Diet, Control | overweight/ obese subjects with normal glucose metabolism for 12 weeks Energy intake was matched with estimated energy expenditure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks |
| BG001 | Diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No data available for diet and diet-control group | Posted | Mean | Standard Error | mg/kg/min | Baseline, 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Gary Frost | Imperial College London | +44 (0)20 7594 0959 | g.frost@imperial.ac.uk |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
|
| 12 weeks |
| Genome Integrity (DNA Methylation and Telomere Length) | 12 weeks |
| Body Weight | Baseline, 12 weeks |
| Result |
| 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. |
| 41259124 | Derived | 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. |
| 40467008 | Derived | 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. |
| 28794208 | Derived | 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. |
overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks
| BG002 | Exercise, Control | An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks |
| BG003 | Diet, Control | overweight/ obese subjects with normal glucose metabolism for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | As shown in table 1 of the publication by Lee at al 2016, the unit measure used was kg/m2. | Mean | Standard Deviation | kg/m^2 |
|
| Fasting glucose | As shown in table 1 of the publication by Lee at al 2016, the unit measure used was mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Total cholesterol | As shown in table 1 of the publication (Lee et al 2016), the unit measure for cholesterol is mg/dL. | Mean | Standard Deviation | mg/dL |
|
| OG002 | Exercise, Control | An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks |
| OG003 | Diet, Control | overweight/ obese subjects with normal glucose metabolism for 12 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | mg/dL | Baseline, 12 weeks |
|
|
|
|
| Secondary | Body Composition | Body Composition assessed by BMI | Posted | Mean | Standard Error | kg/m^2 | Baseline, 12 weeks |
|
|
|
|
| Secondary | Changes in Adipocyte Morphology | Percentage Change in total adipose tissue assessed by MRI | 1 missing data in diet group | Posted | Mean | Standard Error | percentage change | 12 weeks |
|
|
|
|
| Secondary | Genome Integrity (DNA Methylation and Telomere Length) | Data not collected | Posted | 12 weeks |
|
|
| Secondary | Body Weight | Posted | Mean | Standard Error | kg | Baseline, 12 weeks |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Diet | overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Exercise, Control | An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | Diet, Control | overweight/ obese subjects with normal glucose metabolism for 12 weeks | 0 | 5 | 0 | 5 | 0 | 5 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Male |
|
| 12 weeks |
|
| 12 weeks |
|
| t-test, 2 sided |
| <0.05 |
The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance |
| Superiority |
| Baseline vs 12 weeks | t-test, 2 sided | <0.05 | The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance | Superiority |
| 12 weeks |
|