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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01684917
First received: September 11, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted

September 11, 2012
September 11, 2012
April 2012
June 2013   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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.

A cohort of moderately overweight men and women will receive 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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
  • Obesity
  • Diabetes
Behavioral: Energy Intake Restriction
12 week energy intake restriction
Other Name: Energy restriction diet
  • Experimental: Life style advice
    Life style advice: For 12 weeks Subjects will be provided with a diet where energy intake will be 20% less than estimated energy expenditure.
    Intervention: Behavioral: Energy Intake Restriction
  • Active Comparator: UK background diet
    For 12 weeks subjects will be provided with a diet where energy intake will be matched with estimated energy expenditure.
    Intervention: Behavioral: 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.
 
Recruiting
100
December 2013
June 2013   (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
Yes
Contact: Gary S Frost g.frost@imperial.ac.uk
United Kingdom
 
NCT01684917
12/L0/0139
Yes
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