Application of New Technologies and Tools to Nutrition Research

Not Applicable

Completed

• Conditions: Obesity; Diabetes
• Interventions: Behavioral: Metabolomic and Energy Intake Restriction

• Registration Number: NCT01684917
• Lead Sponsor: Imperial College London

Brief Summary

The overall objective of the research is to develop new methods for studying the link between diet, health and disease.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-13
• Primary Completion: 2015-06
• Study Completion: 2016-01
• Results First Submitted: 2019-10-24
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-13
• Last Update Submitted: 2020-01-13
• Results First Posted: 2020-01-27
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)
• Age between 50-65 years

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Metabolomic inquiry	Metabolomic and Energy Intake Restriction	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.
UK background diet	Metabolomic and Energy Intake Restriction	Diet where energy intake will be matched with estimated energy expenditure.
Life style advice	Metabolomic and Energy Intake Restriction	reduce energy intake by 20% less than estimated energy expenditure.

Primary Outcome Measures

Name	Time	Method
Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol	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.
Insulin Sensitivity	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.

Secondary Outcome Measures

Name	Time	Method
Genome Integrity (DNA Methylation and Telomere Length)	12 weeks
Body Composition	Baseline, 12 weeks	Body Composition assessed by BMI
Body Weight	Baseline, 12 weeks
Changes in Adipocyte Morphology	12 weeks	Percentage Change in total adipose tissue assessed by MRI

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom