Diabetes, Obesity
Conditions
Keywords
Obesity, Metabolites
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.
Interventions
BEHAVIORALMetabolomic 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.
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | Baseline, 12 weeks | Body Composition assessed by BMI |
| Changes in Adipocyte Morphology | 12 weeks | Percentage Change in total adipose tissue assessed by MRI |
| Genome Integrity (DNA Methylation and Telomere Length) | 12 weeks | — |
| Body Weight | Baseline, 12 weeks | — |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise 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 | 11 |
| Diet overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks | 7 |
| Exercise, Control 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 | 13 |
| Diet, Control overweight/ obese subjects with normal glucose metabolism for 12 weeks | 5 |
| Total | 36 |
Baseline characteristics
| Characteristic | Total | Exercise, Control | Exercise | Diet, Control | Diet |
|---|---|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 2 | 50 years STANDARD_DEVIATION 2.1 | 53 years STANDARD_DEVIATION 1.7 | 57 years STANDARD_DEVIATION 2.7 | 59 years STANDARD_DEVIATION 1.3 |
| BMI | 28 kg/m^2 STANDARD_DEVIATION 2.3 | 23.5 kg/m^2 STANDARD_DEVIATION 2 | 28.9 kg/m^2 STANDARD_DEVIATION 2.5 | 29.1 kg/m^2 STANDARD_DEVIATION 2 | 30.8 kg/m^2 STANDARD_DEVIATION 3.1 |
| Fasting glucose | 5.2 mmol/L STANDARD_DEVIATION 0.4 | 5.4 mmol/L STANDARD_DEVIATION 0.1 | 5.8 mmol/L STANDARD_DEVIATION 0.4 | 4.6 mmol/L STANDARD_DEVIATION 0.3 | 5.0 mmol/L STANDARD_DEVIATION 0.6 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United Kingdom | 36 participants | 13 participants | 11 participants | 5 participants | 7 participants |
| Sex: Female, Male Female | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 30 Participants | 13 Participants | 11 Participants | 3 Participants | 3 Participants |
| Total cholesterol | 5.2 mg/dL STANDARD_DEVIATION 0.5 | 5.1 mg/dL STANDARD_DEVIATION 0.2 | 5.6 mg/dL STANDARD_DEVIATION 0.5 | 4.9 mg/dL STANDARD_DEVIATION 0.3 | 5.6 mg/dL STANDARD_DEVIATION 1.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 7 | 0 / 13 | 0 / 5 |
| other Total, other adverse events | 0 / 11 | 0 / 7 | 0 / 13 | 0 / 5 |
| serious Total, serious adverse events | 0 / 11 | 0 / 7 | 0 / 13 | 0 / 5 |
Outcome results
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.
Time frame: Baseline, 12 weeks
Population: No data available for diet and diet-control group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Insulin Sensitivity | Baseline | 4.2 mg/kg/min | Standard Error 1.8 |
| Exercise | Insulin Sensitivity | 12 weeks | 5.4 mg/kg/min | Standard Error 1.8 |
| Exercise, Control | Insulin Sensitivity | Baseline | 7.6 mg/kg/min | Standard Error 1.6 |
| Exercise, Control | Insulin Sensitivity | 12 weeks | 10.4 mg/kg/min | Standard Error 2.6 |
Comparison: Baseline vs 12 weeksp-value: <0.05t-test, 2 sided
Comparison: Baseline vs 12 weeksp-value: <0.05t-test, 2 sided
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.
Time frame: Baseline, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol | 12 weeks | 5.8 mg/dL | Standard Error 0.7 |
| Exercise | Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol | Baseline | 5.6 mg/dL | Standard Error 0.5 |
| Diet | Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol | Baseline | 5.6 mg/dL | Standard Error 1.2 |
| Diet | Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol | 12 weeks | 4.9 mg/dL | Standard Error 1.3 |
| Exercise, Control | Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol | Baseline | 5.1 mg/dL | Standard Error 0.2 |
| Exercise, Control | Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol | 12 weeks | 4.9 mg/dL | Standard Error 0.1 |
| Diet, Control | Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol | 12 weeks | 5.1 mg/dL | Standard Error 0.3 |
| Diet, Control | Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol | Baseline | 4.9 mg/dL | Standard Error 0.3 |
Comparison: Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group.p-value: <0.05t-test, 2 sided
Secondary
Body Composition
Body Composition assessed by BMI
Time frame: Baseline, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Body Composition | Baseline | 28.9 kg/m^2 | Standard Error 2.5 |
| Exercise | Body Composition | 12 weeks | 28.6 kg/m^2 | Standard Error 2.4 |
| Diet | Body Composition | 12 weeks | 29.2 kg/m^2 | Standard Error 3 |
| Diet | Body Composition | Baseline | 30.8 kg/m^2 | Standard Error 3.1 |
| Exercise, Control | Body Composition | Baseline | 23.5 kg/m^2 | Standard Error 2 |
| Exercise, Control | Body Composition | 12 weeks | 23.5 kg/m^2 | Standard Error 1.8 |
| Diet, Control | Body Composition | Baseline | 29.1 kg/m^2 | Standard Error 2 |
| Diet, Control | Body Composition | 12 weeks | 29.1 kg/m^2 | Standard Error 2 |
Comparison: Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group.p-value: <0.05t-test, 2 sided
Secondary
Body Weight
Time frame: Baseline, 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Body Weight | Baseline | 92.9 kg | Standard Error 9 |
| Exercise | Body Weight | 12 weeks | 91.6 kg | Standard Error 9.1 |
| Diet | Body Weight | 12 weeks | 87.3 kg | Standard Error 17.4 |
| Diet | Body Weight | Baseline | 91.9 kg | Standard Error 17.8 |
| Exercise, Control | Body Weight | Baseline | 78.5 kg | Standard Error 2.3 |
| Exercise, Control | Body Weight | 12 weeks | 78.3 kg | Standard Error 2.3 |
| Diet, Control | Body Weight | Baseline | 84.7 kg | Standard Error 4.8 |
| Diet, Control | Body Weight | 12 weeks | 84.5 kg | Standard Error 4.9 |
Comparison: Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group.p-value: <0.05t-test, 2 sided
Secondary
Changes in Adipocyte Morphology
Percentage Change in total adipose tissue assessed by MRI
Time frame: 12 weeks
Population: 1 missing data in diet group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | Changes in Adipocyte Morphology | -10.9 percentage change | Standard Error 5.1 |
| Diet | Changes in Adipocyte Morphology | -8.9 percentage change | Standard Error 3.3 |
| Exercise, Control | Changes in Adipocyte Morphology | -8.5 percentage change | Standard Error 2.7 |
| Diet, Control | Changes in Adipocyte Morphology | 3.7 percentage change | Standard Error 1.4 |
Comparison: Baseline vs 12 weeksp-value: <0.05t-test, 2 sided
Comparison: Baseline vs 12 weeksp-value: <0.05t-test, 2 sided
Comparison: Baseline vs 12 weeksp-value: <0.05t-test, 2 sided
Secondary
Genome Integrity (DNA Methylation and Telomere Length)
Time frame: 12 weeks
Population: Data not collected