Assessing metabolic profiling strategies for nutritional management of cardiovascular disease risk
Use of nutritional advice to prevent cardiovascular disease in people with risk factors for cardiovascular disease
The aim of this study is to validate a metabolic profiling model constructed using data from a small study carried out in the months before this study (details of this study are included at the end of this section for reference). Pre-study visit: Two weeks before the study, volunteers will attend the NIHR/Wellcome Trust Imperial CRF at Hammersmith Hospital. The aim of this visit will be to measure height, weight and waist and hip circumference and the baseline samples. 24-h urine and faecal samples will provided by participants from the day before and blood and saliva samples upon arrival. Moreover, the resting energy expenditure of the individual by open loop indirect calorimeter will be measured. Randomisation: Volunteers will be randomly assigned to either the control or the target group. An independent researcher (i.e. not linked to the study) will be given the task of randomisation, which will be by sealed envelopes that will reveal the group assigned for each participant. This researcher will not be directly involved in the study and will use opaque, sealed, sequentially numbered envelopes that each contained “target group” or “control group”. The envelopes will be stored securely, away from the trial site, and opened in sequence by an investigator as each participant is enrolled. Intervention: Participants will be asked to attend the NIHR/Wellcome Trust Imperial CRF at Hammersmith Hospital for a few hours every 2 weeks during a 12-week period. Participants assigned to the target group, will follow a 12-week programme, in which a dietitian will provide personalised dietary advice based on knowledge of urine and plasma metabolic profiles from samples collected at clinic every 2 weeks in addition to 24-h food diaries. Participants assigned to the control group will mirror the intervention group but will receive standard NICE-guideline dietary recommendations. The changes in CVD-risk factors will be compared between the intervention and the control group. Furt
1. Aged between 30 and 65 years 2. At risk of CVD with at least three of the below criteria: 2.1. Body mass index of 20 - 35 kg/m² 2.2. Systolic BP >=140 mmHg or diastolic BP >=90 mmHg, or taking antihypertensive medication 2.3. LDL-cholesterol >= 4.14 mmol/l and HDL-cholesterol <=1.03 mmol/l (men) or <=1.29 mmol/l (women) 2.4. Family history of premature CHD 2.5. Waist circumference >102cm in men or > 88cm in women
1. Have been involved in any other study during the 12 weeks 2. Weight change of >=3kg in the preceding 3 months 3. Substance abuse 4. Excess alcohol intake 5. Taken any dietary supplements in the last 6 months 6. Pregnancy 7. Diabetes 8. Cancer 9. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome 10. Kidney disease 11. Liver disease 12. Pancreatitis 13. Any other chronic illness or being diagnosed with HIV 14. 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 Subjects with the above conditions would have an altered pattern of hormones and inflammatory molecules because of their disease process and would therefore give us confounding or misleading results.