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Effect of whole grain foods on cardiovascular risk

Comparison of effects of increased whole grain foods on markers of cardiovascular risk: a single centre, single blind, randomised controlled longitudinal study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27657880
Enrollment
180
Registered
2010-01-11
Start date
2005-06-30
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight/moderately obese Nutritional, Metabolic, Endocrine Obesity

Interventions

The dietary interventions proposed for this project are designed to compare a diet based on refined cereal products with: 1. The substitution of 3 servings of refined cereals foods with 3 servings of

Sponsors

Food Standards Agency (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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): 1. Serum total and low density lipoprotein (LDL) cholesterol concentrations 2. Insulin sensitivity

Secondary

MeasureTime frame
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).

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026