NutriTech: Application of New Technologies and Tools to Nutrition Research

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT01684917
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Duration (Months): 45
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity; Diabetes	Behavioral: Metabolomic and Energy Intake Restriction	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Application of New Technologies and Tools to Nutrition Research
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Life style advice reduce energy intake by 20% less than estimated energy expenditure.	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.; Other Names: Energy restriction diet Metabolomic
Active Comparator: UK background diet Diet where energy intake will be matched with estimated energy expenditure.	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.; Other Names: Energy restriction diet Metabolomic
Other: Metabolomic inquiry 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.	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.; Other Names: Energy restriction diet Metabolomic

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. Body Composition [Baseline, 12 weeks]

   Body Composition assessed by BMI

2. Changes in Adipocyte Morphology [12 weeks]

   Percentage Change in total adipose tissue assessed by MRI

3. Genome Integrity (DNA Methylation and Telomere Length) [12 weeks]

4. Body Weight [Baseline, 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College London	London		United Kingdom	W12 0NN

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Gary S Frost, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT01684917
• Other Study ID Numbers: 12/L0/0139
• First Posted: Sep 13, 2012
• Last Update Posted: Jan 27, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Obesity; Metabolites
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Exercise	Diet	Exercise, Control	Diet, Control
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks. Energy intake was matched with estimated energy expenditure	An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism for 12 weeks Energy intake was matched with estimated energy expenditure
Period Title: Overall Study
STARTED	11	7	13	5
COMPLETED	11	7	13	5
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Exercise	Diet	Exercise, Control	Diet, Control	Total
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism for 12 weeks	Total of all reporting groups
Overall Participants	11	7	13	5	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (1.7)	59 (1.3)	50 (2.1)	57 (2.7)	55 (2)
Sex: Female, Male (Count of Participants)
Female	0 0%	4 57.1%	0 0%	2 40%	6 16.7%
Male	11 100%	3 42.9%	13 100%	3 60%	30 83.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	11 100%	7 100%	13 100%	5 100%	36 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.9 (2.5)	30.8 (3.1)	23.5 (2)	29.1 (2)	28 (2.3)
Fasting glucose (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	5.8 (0.4)	5.0 (0.6)	5.4 (0.1)	4.6 (0.3)	5.2 (0.4)
Total cholesterol (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	5.6 (0.5)	5.6 (1.2)	5.1 (0.2)	4.9 (0.3)	5.2 (0.5)

Outcome Measures

1. Primary Outcome

Title	Insulin Sensitivity
Description	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

Outcome Measure Data

Analysis Population Description

No data available for diet and diet-control group

Arm/Group Title	Exercise	Diet	Exercise, Control	Diet, Control
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism for 12 weeks
Measure Participants	11	0	13	0
Baseline	4.2 (1.8)	7.6 (1.6)
12 weeks	5.4 (1.8)	10.4 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise
	Comments	Baseline vs 12 weeks
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Exercise, Control
	Comments	Baseline vs 12 weeks
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Diet	Exercise, Control	Diet, Control
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism for 12 weeks
Measure Participants	11	7	13	5
Baseline	5.6 (0.5)	5.6 (1.2)	5.1 (0.2)	4.9 (0.3)
12 weeks	5.8 (0.7)	4.9 (1.3)	4.9 (0.1)	5.1 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diet
	Comments	Baseline vs 12 weeks. Statistical Analysis was performed only for the "Diet" Arm/Group.
	Type of Statistical Test	Superiority
	Comments	Statistical Analysis was performed only for the "Diet" Arm/Group
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Body Composition
Description	Body Composition assessed by BMI
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Diet	Exercise, Control	Diet, Control
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism for 12 weeks
Measure Participants	11	7	13	5
Baseline	28.9 (2.5)	30.8 (3.1)	23.5 (2)	29.1 (2)
12 weeks	28.6 (2.4)	29.2 (3)	23.5 (1.8)	29.1 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diet
	Comments	Baseline vs 12 weeks. Statistical Analysis was performed only for the "Diet" Arm/Group.
	Type of Statistical Test	Superiority
	Comments	Statistical Analysis was performed only for the "Diet" Arm/Group
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Changes in Adipocyte Morphology
Description	Percentage Change in total adipose tissue assessed by MRI
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

1 missing data in diet group

Arm/Group Title	Exercise	Diet	Exercise, Control	Diet, Control
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism for 12 weeks
Measure Participants	7	6	13	5
Mean (Standard Error) [percentage change]	-10.9 (5.1)	-8.9 (3.3)	-8.5 (2.7)	3.7 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise
	Comments	Baseline vs 12 weeks
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diet
	Comments	Baseline vs 12 weeks
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Exercise, Control
	Comments	Baseline vs 12 weeks
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Genome Integrity (DNA Methylation and Telomere Length)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	Exercise	Diet	Exercise, Control	Diet, Control
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism for 12 weeks
Measure Participants	0	0	0	0

6. Secondary Outcome

Title	Body Weight
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Diet	Exercise, Control	Diet, Control
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	overweight/ obese subjects with normal glucose metabolism for 12 weeks
Measure Participants	11	7	13	5
Baseline	92.9 (9)	91.9 (17.8)	78.5 (2.3)	84.7 (4.8)
12 weeks	91.6 (9.1)	87.3 (17.4)	78.3 (2.3)	84.5 (4.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diet
	Comments	Baseline vs 12 weeks. Statistical Analysis was performed only for the "Diet" Arm/Group.
	Type of Statistical Test	Superiority
	Comments	Statistical Analysis was performed only for the "Diet" Arm/Group
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Exercise		Diet		Exercise, Control		Diet, Control
Arm/Group Description	An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks		overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks		An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks		overweight/ obese subjects with normal glucose metabolism for 12 weeks
All Cause Mortality
	Exercise		Diet		Exercise, Control		Diet, Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/7 (0%)		0/13 (0%)		0/5 (0%)
Serious Adverse Events
	Exercise		Diet		Exercise, Control		Diet, Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/7 (0%)		0/13 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Exercise		Diet		Exercise, Control		Diet, Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/7 (0%)		0/13 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.