Metabolically personalised dietary advice for people at risk of cardiovascular disease

Not Applicable

• Conditions: se of nutritional advice to prevent cardiovascular disease in people with risk factors for cardiovascular disease; Circulatory System

• Registration Number: ISRCTN44705179
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-04
• Last Update Posted: 4 September 2023
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rinary and blood metabolic profiles measured from urine and blood samples using Nuclear Magnetic Resonance and Mass Spectrometry at baseline and then once every 2 weeks, for 12 weeks

Secondary Outcome Measures

Name	Time	Method
1. Dietary biomarkers present in urine, blood, faeces, and saliva samples measured at baseline and then once every 2 weeks, for 12 weeks using metabolic profiling analysis <br>2. Participants eating behaviour measured using 24-h food diary measured once every 2 weeks, for 12 weeks<br>3. C-reactive protein (CRP) measured at baseline and 12 weeks<br>4. HbA1c measured at baseline and 12 weeks<br>5. Blood pressure (mmHg) measured using a sphygmomanometer at baseline and then once every 2 weeks, for 12 weeks<br>6. BMI (kg/m²) at baseline and then once every 2 weeks, for 12 weeks<br>7. Waist circumference (cm) at baseline and then once every 2 weeks, for 12 weeks