Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000158460
Ethics application status
Approved
Date submitted
1/03/2007
Date registered
6/03/2007
Date last updated
6/03/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Breakfast Intervention Study
Scientific title
To Investigate if sesame seed bars compared to placebo bars can positively impact on risk factors of cardiovascular disease and vitamin E metabolism in subjects with at least one clinical feature of the metabolic syndrome.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk factors for cardiovascular disease such as hypertension and hypercholesterolemia in subjects with at least one clinical feature of the metabolic syndrome. 1660 0
Condition category
Condition code
Cardiovascular 1765 1765 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised, placebo controlled cross-over trial. Volunteers will be randomised with 1 group receiving 25grams of sesame seeds (in a bar format) daily for 5 weeks. The bars will replace the volunteers usual breakfast intake. After a 4 week washout period, the volunteers will receive the alternative bars for another 5 weeks
Intervention code [1] 1621 0
Lifestyle
Comparator / control treatment
Volunteers will be randomised with 1 group receiving a placebo bar (containing the same macronutrients but without sesame seeds) for 5 weeks. The bars will replace the volunteers usual breakfast intake.
Control group
Placebo

Outcomes
Primary outcome [1] 2467 0
1. Blood cholesterol levels.
Timepoint [1] 2467 0
Measured at baseline (at the beginning of the study and also at the end of week 9, i.e. after the wash out period) and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14)
Primary outcome [2] 2468 0
2. Blood pressure (ambulatory blood pressure monitoring).
Timepoint [2] 2468 0
Measured at baseline (at the beginning of the study and also at the end of week 9, i.e. after the wash out period) and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14)
Primary outcome [3] 2469 0
3.Serum vitamin E and mammalian lignan levels.
Timepoint [3] 2469 0
Measured at baseline (at the beginning of the study and also at the end of week 9, i.e. after the wash out period) and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14)
Primary outcome [4] 2470 0
4.Urinary vitamin E metabolite levels.
Timepoint [4] 2470 0
Measured at baseline (at the beginning of the study and also at the end of week 9, i.e. after the wash out period) and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14)
Secondary outcome [1] 4233 0
1. Oxidative stress (plasma and urinary F2-isoprostanes).
Timepoint [1] 4233 0
Measured at the beginning of the study and also at the end of week 9, i.e. after the wash out period, and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14).
Secondary outcome [2] 4234 0
2.Biomarkers of endothelial cell and platelet activation (soluble CD40 ligand, P-selectin, vascular cell adhesion molecule and intercellular adhesion molecules).
Timepoint [2] 4234 0
Measured at the beginning of the study and also at the end of week 9, i.e. after the wash out period, and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14).
Secondary outcome [3] 4235 0
3.Urinary 20-Hydroxyeicosatetraenoic acid levels.
Timepoint [3] 4235 0
Measured at the beginning of the study and also at the end of week 9, i.e. after the wash out period, and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14).
Secondary outcome [4] 4236 0
4.Serum markers of inflammation (C-reactive protein, Interleukin-6 and Tumor necrosis factor-alpha).
Timepoint [4] 4236 0
Measured at the beginning of the study and also at the end of week 9, i.e. after the wash out period, and immediately following each of the food bar interventions (i.e. at the end of weeks 5 and 14).

Eligibility
Key inclusion criteria
With at least one clinical feature of the metabolic syndrome as defined by the American Heart Association.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Use of pure vitamin E supplements. 2.Gastrointestinal disorders. 3.Used antibiotics 4 weeks prior to the study. 4.Alcohol intake >40g/day men 30g/day women. 5.Pre and perimenopausal women. 6.Smoking. 7.Recent coronary/cerebrovascular event <6months. Evidence of renal impairment. 8.Body Mass Index >35. 9.Use of lipid or hypertensive medications. 10. Diabetes requiring insulin. 11. Episodic use of non-steroidal anti-inflammatory medication. 12. History of heart failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Newspaper advertisement of study, followed by telephone screening and screening visit by potential volunteers to determine suitability to be enrolled in the study. Volunteers who meet the study criteria and are willing to participate will sign a consent form before taking part in the study. Sesame and placebo bars will be handed out in pre-packaged boxes coded 'A' and 'B' and all personnel to be involved in sample and data analysis will be blinded to the coding of the bars.Volunteers will be randomised to receive one of the two possible treatment orders (sesame bars followed by placebo bars, and vice versa). The randomisation sequence will be generated prior to enrollment of patients and sealed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated block randomisation using computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The study will be double-blinded with all project personnel (those involved in administering the treatment, as well as those assessing the outcomes and data) blinded to the sequence of treatment the volunteers underwent. However because of a noticeble taste difference between the two bar formulations, the volunteers will be aware of their treatment.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1917 0
Government body
Name [1] 1917 0
National Health and Medical Research Council
Country [1] 1917 0
Australia
Primary sponsor type
University
Name
University of Western Australia, School of Medicine and Pharmacology.
Address
Country
Australia
Secondary sponsor category [1] 1729 0
None
Name [1] 1729 0
N/A
Address [1] 1729 0
Country [1] 1729 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3565 0
University of Western Australia Human Research Ethics Committee-School of Medicine and Pharmacology Clinical Trials Unit (University of Western Australia) at Royal Perth Hospital
Ethics committee address [1] 3565 0
Ethics committee country [1] 3565 0
Australia
Date submitted for ethics approval [1] 3565 0
Approval date [1] 3565 0
05/01/2007
Ethics approval number [1] 3565 0
RA/4/1/1355

Summary
Brief summary
This study aims to evaluate the effects of two food bar formulations. One of the bars is wheat bran based, and the other sesame seed based. Both formulations are high in fibre and unsaturated fats, which have been shown in previous studies to reduce heart disease risk factors such as blood cholesterol. This study is designed to assess if different dietary sources of fibre and unsaturated fats will have similar or different benefit in reducing heart disease risk factors. The study will be single-blinded with the study co-ordinator blinded to the sequence of treatment the volunteers underwent. However because of a noticeble taste difference between the two bar formulations, the volunteers will be aware of their treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27555 0
Address 27555 0
Country 27555 0
Phone 27555 0
Fax 27555 0
Email 27555 0
Contact person for public queries
Name 10810 0
Professor Kevin Croft
Address 10810 0
School of Medicine and Pharmacology (Royal Perth Hospital), University of Western Australia Box X2213 GPO Perth WA 6847
Country 10810 0
Australia
Phone 10810 0
+61 8 92240275
Fax 10810 0
+61 8 92240246
Email 10810 0
[email protected]
Contact person for scientific queries
Name 1738 0
Professor Kevin Croft
Address 1738 0
School of Medicine and Pharmacology (Royal Perth Hospital), University of Western Australia Box X2213 GPO Perth WA 6847
Country 1738 0
Australia
Phone 1738 0
+61 8 92240275
Fax 1738 0
+61 8 92240246
Email 1738 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
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