Application of New Technologies and Tools to Nutrition Research

Imperial College London36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Obesity Diabetes

Interventions

Metabolomic and Energy Intake RestrictionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Imperial College London

London, United Kingdom

Outcomes

Primary Outcomes

Insulin Sensitivity

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.

Time frame: Baseline, 12 weeks

Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol

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

Time frame: Baseline, 12 weeks

Secondary Outcomes

Body Composition

Body Composition assessed by BMI

Time frame: Baseline, 12 weeks

Changes in Adipocyte Morphology

Percentage Change in total adipose tissue assessed by MRI

Time frame: 12 weeks

Genome Integrity (DNA Methylation and Telomere Length)

Time frame: 12 weeks

Body Weight

Time frame: Baseline, 12 weeks

Data from ClinicalTrials.gov

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