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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Imperial College London
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
  Purpose

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.


Condition Intervention
Obesity
Diabetes
Behavioral: Energy Intake Restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Application of New Technologies and Tools to Nutrition Research

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Energy Intake Restriction
12 week energy intake restriction
Other Name: Energy restriction diet
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.
Behavioral: Energy Intake Restriction
12 week energy intake restriction
Other Name: Energy restriction diet

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684917

Contacts
Contact: Gary S Frost g.frost@imperial.ac.uk

Locations
United Kingdom
Imperial College London Recruiting
London, United Kingdom, W12 0NN
Contact: Gary S Frost       g.frost@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Gary S Frost Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01684917     History of Changes
Other Study ID Numbers: 12/L0/0139
Study First Received: September 11, 2012
Last Updated: September 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014