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Completed

NCT Number: NCT01684917

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.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

London, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metabolomic and Energy Intake Restriction

Behavioral

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.

Other names: Energy restriction diet, Metabolomic

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Baseline, 12 weeks

    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.

  2. Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol

    Time frame: Baseline, 12 weeks

    Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the "Diet" Arm/Group.

Secondary outcomes

  1. Body Composition

    Time frame: Baseline, 12 weeks

    Body Composition assessed by BMI

  2. Changes in Adipocyte Morphology

    Time frame: 12 weeks

    Percentage Change in total adipose tissue assessed by MRI

  3. Genome Integrity (DNA Methylation and Telomere Length)

    Time frame: 12 weeks

  4. Body Weight

    Time frame: Baseline, 12 weeks

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: NutriTech

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Sep 13, 2012
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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