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Trial registered on ANZCTR


Registration number
ACTRN12606000034538
Ethics application status
Approved
Date submitted
20/01/2006
Date registered
25/01/2006
Date last updated
31/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of regular consumption of lupin kernel flour-enriched foods on risk factors for heart disease
Scientific title
Effects of regular consumption of lupin kernel flour-enriched foods on risk factors for heart disease in overweight healthy subjects
Universal Trial Number (UTN)
Trial acronym
LKF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk factors for heart disease in overweight healthy subjects 997 0
Condition category
Condition code
Diet and Nutrition 1072 1072 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine the effects of modest replacement of wheat-derived carbohydrate with protein and fibre derived from lupin kernel flour (LKF) on body weight, body fat, blood pressure and other cardiovascular disease risk factors
Randomised, controlled, parallel-designed study of 4 months duration. Participants will be assigned to one of two groups where approximately 15% of total daily energy intake will be consumed from one of two different breads:

1.bread made from refined wheat flour – based on regular commercially available white bread;

2.bread where 40% of the wheat flour is replaced with LKF – based on regular commercially available white bread with increased protein and fibre from LKF. The bread (~4 to 6 slices per day, depending on usual energy intake) will be consumed throughout the day with main meals, for breakfast, lunch and dinner.This study is not designed to have participants consciously reduce energy intake and lose weight. The objective is to determine if the LKF-enriched bread can influence appetite and energy intake longer-term and ultimately influence body weight. Therefore, all diets will be ad libitum. However, because participants are overweight and as a group will have increased risk of cardiovascular disease, all participants will receive advice on lifestyle modification prior to randomization. The advice will be provided at a single 1-hour consultation with a dietitian prior to randomization. At the consultation, the dietitian will concentrate on the appropriate modifications for each individual, and provide printed educational material from the National Heart Foundation of Australia to refer to at home.Participants will attend the University of WA School of Medicine and Pharmacology at Royal Perth Hospital on a total of 3 occasions at baseline and 3 occasions at end of intervention to complete the above assessments. Each of these visits will last about 30 to 90 minutes. In addition, during the 4 month intervention, participants will attend the Department at fortnightly (2-week) intervals. At these visits progress will be monitored, body weight and body composition will be assessed using bioimpedence, and a fortnight’s bread will be suppled to participants.
Intervention code [1] 852 0
None
Comparator / control treatment
Bread made from refined wheat flour – based on regular commercially available white bread
Control group
Active

Outcomes
Primary outcome [1] 1435 0
A food history questionnaire was administered by a dietition at baseline and at the end of the intervention.
Timepoint [1] 1435 0
Measured at baseline and end of intervention
Primary outcome [2] 1436 0
2.24 hour ambulatory blood pressure
Blood pressure will be assessed as 24-hour ambulatory blood pressure. A trained nurse will fit a Spacelabs monitor (Spacelabs Medical Inc. Redmond, WA, USA) and explain its use to the participants. Blood pressure and heart rate are measured every 20 min during the day and every 30 min overnight. Participants are instructed to continue their usual daily activities and to avoid any vigorous exercise. They fill out an activity diary, which includes waking and sleeping times. Measurements showing an error code or those with a pulse pressure of less than 20 mm Hg are excluded from the analysis. Blood pressure traces that are missing more than four hourly means over the 24 hours are excluded from the analysis.
Timepoint [2] 1436 0
Measured at baseline and end of intervention
Primary outcome [3] 1437 0
3.Fasting plasma glucose and insulin concentrations, and glycated haemoglobin; blood lipid and lipoprotein concentrations; biochemical markers of satiety; and routine biochemistry and haematologySingle biochemical and haematological measurements will be performed at baseline and at the end of intervention. Fasting venous blood samples and 24-hour urine samples will be collected. Measurements will include urinary and serum sodium, potassium and creatinine, plasma glucose, serum insulin, plasma leptin, serum cholesterol, triglycerides and high-density lipoprotein cholesterol. These measurements will be performed in the Department of Clinical Biochemistry at Royal Perth Hospital using routine methods
Timepoint [3] 1437 0
Measured at baseline and end of intervention
Secondary outcome [1] 2540 0
Body weight, body fat and body composition. Height will be measured using a wall-mounted stadiometer. Body weight, body fat mass and percentage, total body water and fat free mass will be measured in the clinic (using bioimpedance) and DEXA. The waist measurement will be taken at the point midway between the two bony landmarks of the lower ribcage and the superior iliac crest. The hip circumference will be taken at the maximum gluteal diameter.
Timepoint [1] 2540 0
Body weight and composition measurement will be performed at all visits at baseline and throughout the 4 month intervention.
At two visits at baseline and end of intervention, waist and hip circumference measurements will be performed.

Eligibility
Key inclusion criteria
Otherwise healthy, but overweight, with BMI between 25 and 35 will be recruited. Volunteers will have no history of major chronic disease
Minimum age
20 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes, treated hypertension, symptomatic left ventricular failure, recent myocardial infarction (<6 months), unstable angina pectoris, uncontrolled hypertension, history of liver, renal or gastrointestinal disease, smoking, alcohol intake >40g/day, BMI> 35kg/m2, history of asthma, history of allergy to food or other environmental factors.

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)
Computer generated random no placed into opaque sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random no placed into opaque sealed envelope
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1172 0
Government body
Name [1] 1172 0
Western Australia Department of Agricultural
Address [1] 1172 0
Perth, WA
Country [1] 1172 0
Australia
Primary sponsor type
Government body
Name
Western Australia Department of Agricultural
Address
Perth, WA
Country
Australia
Secondary sponsor category [1] 1034 0
University
Name [1] 1034 0
School of Medicine and Pharmacology, University of Western Australia
Address [1] 1034 0
Perth, WA
Country [1] 1034 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2492 0
School of Medicine and Pharmacology
Ethics committee address [1] 2492 0
Ethics committee country [1] 2492 0
Australia
Date submitted for ethics approval [1] 2492 0
Approval date [1] 2492 0
Ethics approval number [1] 2492 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35286 0
Address 35286 0
Country 35286 0
Phone 35286 0
Fax 35286 0
Email 35286 0
Contact person for public queries
Name 10041 0
Dr Jonathan HODGSON
Address 10041 0
School of Medicine and Pharmacology
University of Western Australia
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 10041 0
Australia
Phone 10041 0
+61 8 92240267
Fax 10041 0
+61 8 92240246
Email 10041 0
jonathan@cyllene.uwa.edu.au
Contact person for scientific queries
Name 969 0
Ya Ping LEE
Address 969 0
School of Medicine and Pharmacology
University of Western Australia
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 969 0
Australia
Phone 969 0
+61 8 92240344
Fax 969 0
+61 8 92240243
Email 969 0
yplee@meddent.uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary