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Description of intervention(s) / exposure:
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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.
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| Intervention code: | None |
 Comparator / control treatment:
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Bread made from refined wheat flour – based on regular commercially available white bread
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Control group: |
Active |
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Page 4
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| Primary outcome 1: | A food history questionnaire was administered by a dietition at baseline and at the end of the intervention. |
| Timepoint: | Measured at baseline and end of intervention |
| Primary outcome 2: | 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: | Measured at baseline and end of intervention |
| Primary outcome 3: | 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: | Measured at baseline and end of intervention |
| Secondary outcome: | 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: | 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. |
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Key inclusion criteria:
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Otherwise healthy, but overweight, with BMI between 25 and 35 will be recruited. Volunteers will have no history of major chronic disease |
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Minimum Age:
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20
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Maximum Age:
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70
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Gender:
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Both males and females |
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Healthy volunteers?
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No |
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Key exclusion criteria:
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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. |
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Page 6
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Study type: |
Interventional |
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Purpose of the study: |
Prevention |
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Allocation to intervention: |
Randomised controlled trial |
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): |
Computer generated random no placed into opaque sealed envelope |
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): |
Computer generated random no placed into opaque sealed envelope |
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Masking / blinding: |
Blinded (masking used) |
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Assignment: |
Parallel |
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Type of endpoint(s): |
Efficacy |
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Page 7
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Phase |
Phase 1 |
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Anticipated or actual start date: |
1/04/2006 |
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Target sample size: |
80 |
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Recruitment status: |
Completed |
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Page 8
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| Funding source: | Government funding body e.g. Australian Research Council |
| Name: | Western Australia Department of Agricultural |
| Address: | Perth, WA |
| Country: | Australia |
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Primary sponsor: |
Government funding body e.g. Department of Health |
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Western Australia Department of Agricultural |
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Perth, WA |
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Australia |
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| Secondary sponsor: | University |
| Name: | School of Medicine and Pharmacology, University of Western Australia |
| Address: | Perth, WA |
| Country: | Australia |
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Has the study received approval from at least one ethics committee? |
Yes |
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| Ethics Committee name: | School of Medicine and Pharmacology |
| Address: | |
| Country: | Australia |
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| Countries of recruitment: | Australia |
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Page 10
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Contact person for public queries
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Name: |
Dr Jonathan HODGSON |
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Address: |
School of Medicine and Pharmacology
University of Western Australia
Royal Perth Hospital
GPO Box X2213
Perth WA 6847 |
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Australia |
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+61 8 92240267 |
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+61 8 92240246 |
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jonathan@cyllene.uwa.edu.au |
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Contact person for scientific queries |
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Name: |
Ya Ping LEE |
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Address: |
School of Medicine and Pharmacology
University of Western Australia
Royal Perth Hospital
GPO Box X2213
Perth WA 6847 |
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Australia |
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yplee@meddent.uwa.edu.au |
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International Committee of Medical Journal Editors (ICMJE): June 2007 editorial
International Committee of Medical Journal Editors (ICMJE): May 2005 editorial
WHO International Clinical Trials Registry Platform (ICTRP)
The World Health Organization announces new standards for registration of all human medical research
WHO trial registration data set
NHMRC Clinical Trials Centre
National Health and Medical Research Council (NHMRC) information about the ANZCTR
Frequently Asked Questions about the ANZCTR
About the ANZCTR
How to register a trial
How to update a trial