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

Imperial College London

Status: Completed

Conditions: Diabetes; Obesity

Treatments: Behavioral: Metabolomic and Energy Intake Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT01684917

12/L0/0139

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Life style advice

Experimental group

Description:

reduce energy intake by 20% less than estimated energy expenditure.

Treatment:

Behavioral: Metabolomic and Energy Intake Restriction

UK background diet

Active Comparator group

Description:

Diet where energy intake will be matched with estimated energy expenditure.

Treatment:

Behavioral: Metabolomic and Energy Intake Restriction

Metabolomic inquiry

Other group

Description:

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.

Treatment:

Behavioral: Metabolomic and Energy Intake Restriction