Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000176561
Ethics application status
Approved
Date submitted
26/01/2015
Date registered
23/02/2015
Date last updated
23/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Health And Bread Intervention Trials: Effect of changing bread composition on cardiovascular disease marker.
Scientific title
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.

Secondary ID [1] 286050 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 294027 0
Blood pressure 294028 0
Condition category
Condition code
Cardiovascular 294331 294331 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291036 0
Lifestyle
Intervention code [2] 291110 0
Prevention
Comparator / control treatment
Commercially available bread which will replace the participants normal bread consumption 6 plus slices per day.
Control group
Active

Outcomes
Primary outcome [1] 294130 0
Blood pressure, will be measured in triplicate using a SphygmoCor (AtCor medical). The participant will be seated for at rest for at least 15 minutes prior to the test.
Timepoint [1] 294130 0
12 weeks
Primary outcome [2] 294131 0
Pulse wave analysis and pulse wave velocity will be measured using a SphygmoCor (AtCor medical), this will be completed following the blood pressure measurement.
Timepoint [2] 294131 0
12 weeks
Secondary outcome [1] 312583 0
Body composition - segmental body composition will be measured by bioelectrical impedance (BIA), (Tanita). Participants will have arrived at the clinic fasted for all tests.
Timepoint [1] 312583 0
12 weeks
Secondary outcome [2] 312584 0
Consumer acceptability - . Hedonic ratings, (overall liking) of the breads will be measured during a sensory testing session in the laboratory at baseline and upon completion of the 12-week intervention period. In addition, monotony ratings (desire to consume) and ‘overall liking’ of the nuts breads will be measured at weekly intervals during the intervention. Ratings of ‘overall liking’ and ‘desire to consume’ will be measured on 150mm visual analogue scales (VAS).
Timepoint [2] 312584 0
12 weeks
Secondary outcome [3] 312896 0
Blood loTotal cholesterol, HDL-cholesterol and triglycerides will be measured. Two blood samples will be collected during each testing week to account for intra-individual variation in blood lipid measures. Total and HDL-cholesterol and triglyceride concentrations will be measured by enzymatic methods using a Cobas Mira Plus analyser. Plasma low density lipoprotein cholesterol concentration will be calculated using the Friedewald formula
Timepoint [3] 312896 0
12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 6614 0
New Zealand
State/province [1] 6614 0

Funding & Sponsors
Funding source category [1] 290637 0
Government body
Name [1] 290637 0
Health Research Council
Country [1] 290637 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 289331 0
None
Name [1] 289331 0
Address [1] 289331 0
Country [1] 289331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292270 0
University of Otago Human (HEALTH) Ethics Committee
Ethics committee address [1] 292270 0
PO Box 56
Dunedin
9054
Ethics committee country [1] 292270 0
New Zealand
Date submitted for ethics approval [1] 292270 0
Approval date [1] 292270 0
28/10/2014
Ethics approval number [1] 292270 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54406 0
Dr Katherine Black
Address 54406 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 54406 0
New Zealand
Phone 54406 0
+ 64 3 479 8358
Fax 54406 0
Email 54406 0
[email protected]
Contact person for public queries
Name 54407 0
Katherine Black
Address 54407 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 54407 0
New Zealand
Phone 54407 0
+ 64 3 479 8358
Fax 54407 0
Email 54407 0
[email protected]
Contact person for scientific queries
Name 54408 0
Katherine Black
Address 54408 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 54408 0
New Zealand
Phone 54408 0
+ 64 3 479 8358
Fax 54408 0
Email 54408 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.