NCT01684917

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

September 11, 2012

Results QC Date

October 24, 2019

Last Update Submit

January 13, 2020

Conditions

ObesityDiabetes

Keywords

ObesityMetabolites

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Body Composition

    Baseline, 12 weeks

  • Changes in Adipocyte Morphology

    12 weeks

  • Genome Integrity (DNA Methylation and Telomere Length)

    12 weeks

  • Body Weight

    Baseline, 12 weeks

Study Arms (3)

Life style advice

EXPERIMENTAL

reduce energy intake by 20% less than estimated energy expenditure.

Behavioral: Metabolomic and Energy Intake Restriction

UK background diet

ACTIVE COMPARATOR

Diet where energy intake will be matched with estimated energy expenditure.

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.

Behavioral: Metabolomic and Energy Intake Restriction

Interventions

Metabolomic and Energy Intake RestrictionBEHAVIORAL

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.

Also known as: Energy restriction diet, Metabolomic
Life style adviceMetabolomic inquiryUK background diet

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, W12 0NN, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 27821717RESULT

  • 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.

    PMID: 28122782RESULT

  • 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.

    PMID: 40467008DERIVED

  • 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.

    PMID: 28794208DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Professor Gary Frost
Organization
Imperial College London
g.frost@imperial.ac.uk
+44 (0)20 7594 0959

Study Officials

  • Gary S Frost

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 13, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2015

Study Completion

January 1, 2016

Last Updated

January 27, 2020

Results First Posted

January 27, 2020

Record last verified: 2020-01

Locations

GB(1)