Effect of whole grain foods on cardiovascular risk

Completed

• Conditions: Overweight/moderately obese; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN27657880
• Lead Sponsor: Food Standards Agency (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Men and women aged 40 - 65 years
2. Body mass index (BMI in kg/m^2) between 25 and 35
3. Recruited from the surrounding community of Aberdeen
4. Sedentary or moderately active (less than two aerobic session per week)
5. Present signs of metabolic syndrome, e.g. if he/she has three or more of the following conditions:
5.1. Fasting plasma glucose greater than 6.1 mm/L
5.2. Triacylglycerol (TAG) level greater than 1.7 mmol/L
5.3. Low high density lipoprotein (HDL) cholesterol (less than 1.04 mmol/L for men, less than 1.29 mmol/L for women)
5.4. Hypertension (greater than 130/85 mmHg)
5.5. Central obesity (waist circumference greater than 102 cm for men, greater than 88 cm for women)
5.6. Moderate hypercholesterolemia

Exclusion Criteria

1. Cardiovascular disease (CVD)
2. Diabetes or fasting blood glucose concentration greater than 7.0 mmol/L
3. Asthma
4. Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 99 mmHg
5. Thyroid gland disorders or eating disorders
6. Taking regular medication or supplements known to affect any dependant variable measured
7. Volunteers with high habitual intake of whole-grain foods (greater than 5 servings per week)
8. Taking regular nutritional supplements such as antioxidants or fish oil

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All outcome measures were determined four times during the intervention: prior run-in (T0), after run-in period (4 weeks, baseline), at week 10 and week 16 (end of intervention):<br>1. Serum total and low density lipoprotein (LDL) cholesterol concentrations<br>2. Insulin sensitivity

Secondary Outcome Measures

Name	Time	Method
Measurement of vascular function and inflammation markers (vascular tonicity by pulse-wave velocity and pulse contour analysis, intercellular adhesion molecule 1 [ICAM-1], interleukin-6 [IL-6] and high sensitivity C-reactive protein [hsCRP]). All outcome measures were determined four times during the intervention: prior run-in (T0), after run-in period (4 weeks, baseline), at week 10 and week 16 (end of intervention).