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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01684917
First received: September 11, 2012
Last updated: October 26, 2016
Last verified: September 2012

September 11, 2012
October 26, 2016
April 2012
June 2015   (final data collection date for primary outcome measure)
  • Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Metabolomic biomarker discovery [ Time Frame: 3 day ] [ Designated as safety issue: No ]
Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01684917 on ClinicalTrials.gov Archive Site
  • Body weight and composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adipocyte morphology, differentiation and signalling [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Genome integrity (DNA methylation and telomere length) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Application of New Technologies and Tools to Nutrition Research
Application of New Technologies and Tools to Nutrition Research

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Obesity
  • Diabetes
Behavioral: Metabolomic and Energy Intake Restriction
Metabolomic inquiry followed by a 12 week energy intake restriction
Other Names:
  • Energy restriction diet
  • Metabolomic
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
January 2016
June 2015   (final data collection date for primary outcome measure)

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.
Both
50 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01684917
12/L0/0139
Yes
Not Provided
Not Provided
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Gary S Frost Imperial College London
Imperial College London
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP