Health And Bread Intervention Trials: Effect of changing bread composition on cardiovascular disease marker.

The effect of a 12 week intervention changing the composition bread, so its composition is either lower in sodium or contains nuts or beetroot, on markers of cardiovascular disease in comparison to a control bread amongst those with at least one characteristic of the metabolic syndome.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000176561

Enrollment

200

Registered

2015-02-23

Start date

2015-02-24

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The aim of this study is to determine the impact of changing the composition of a dietary staple (bread), so its composition is either lower in sodium or higher in nitrate or L-arginine, on markers of cardiovascular disease i.e. blood pressure, endothelial (blood vessel) function and blood lipids in comparison to a control bread.

Interventions

Participants will be assigned to one of the study’s four arms for a period of 12 weeks. The four arms consist of: 1) a low sodium bread (1g of salt per 100g bread), 2) a beetroot bread which is high in nitrate (35g beetroot per 100g bread), 3) a nut bread which is high in L-arginine and unsaturated fats (30g nuts per 100g bread) and 4) a control bread. Participants will be provided with bread throughout the study. Adherence will be monitored via tick sheets, volume of bread uneaten, and changes in plasma nitrate/nitrite concentrations, urinary sodium and food diaries. Apart from changing the bread composition, participants will be allowed to eat their usual diet. Participants should consume 6 slices or more of bread per day.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Participants will be included if they have at least one of the following indicators for metabolic syndrome; a waist circumference >102 cm for men or >88 cm for women, elevated triglycerides >1.7 mmol/L, HDL-C <1.0 mmol/L in men and <1.3 mmol/L in women, blood pressure > 130 mmHg systolic or > 85 mmHg for diastolic or a fasting blood glucose >100 mg/dL or a BMI>25 will be recruited.

Exclusion criteria

Males and females with chronic disease e.g. cancer, cardiovascular disease, diabetes, anyone with a food allergy, those on a calorie restricted diet.

Outcome results