Application of New Technologies and Tools to Nutrition Research

Obesity Clinical Trial

— NutriTech  

Official title:

Application of New Technologies and Tools to Nutrition Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684917
• Other study ID #: 12/L0/0139
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Behavioral:
• Metabolomic and Energy Intake Restriction
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.

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Cheung W, Keski-Rahkonen P, Assi N, Ferrari P, Freisling H, Rinaldi S, Slimani N, Zamora-Ros R, Rundle M, Frost G, Gibbons H, Carr E, Brennan L, Cross AJ, Pala V, Panico S, Sacerdote C, Palli D, Tumino R, Kühn T, Kaaks R, Boeing H, Floegel A, Mancini F, B — View Citation

Lee S, Norheim F, Langleite TM, Noreng HJ, Storås TH, Afman LA, Frost G, Bell JD, Thomas EL, Kolnes KJ, Tangen DS, Stadheim HK, Gilfillan GD, Gulseth HL, Birkeland KI, Jensen J, Drevon CA, Holen T; NutriTech Consortium. Effect of energy restriction and ph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 weeks
Primary	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.	Baseline, 12 weeks
Secondary	Body Composition	Body Composition assessed by BMI	Baseline, 12 weeks
Secondary	Changes in Adipocyte Morphology	Percentage Change in total adipose tissue assessed by MRI	12 weeks
Secondary	Genome Integrity (DNA Methylation and Telomere Length)		12 weeks
Secondary	Body Weight		Baseline, 12 weeks