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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
  Purpose

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.


Condition Intervention Phase
Obesity
Diabetes
Behavioral: Metabolomic and Energy Intake Restriction
Phase 3

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

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Metabolomic biomarker discovery [ Time Frame: 3 day ] [ 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 ]

Enrollment: 74
Study Start Date: April 2012
Study Completion Date: January 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Life style advice
reduce energy intake by 20% less than estimated energy expenditure.
Behavioral: Metabolomic and Energy Intake Restriction
Metabolomic inquiry followed by a 12 week energy intake restriction
Other Names:
  • Energy restriction diet
  • Metabolomic
Active Comparator: UK background diet
Diet where energy intake will be matched with estimated energy expenditure.
Behavioral: Metabolomic and Energy Intake Restriction
Metabolomic inquiry followed by a 12 week energy intake restriction
Other Names:
  • Energy restriction diet
  • Metabolomic
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.
Behavioral: Metabolomic and Energy Intake Restriction
Metabolomic inquiry followed by a 12 week energy intake restriction
Other Names:
  • Energy restriction diet
  • Metabolomic

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years   (Adult)
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

Locations
United Kingdom
Imperial College London
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Gary S Frost Imperial College London
  More Information

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: October 26, 2016
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on December 02, 2016