Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

001014

ACTR Number:

ACTRN12606000034538

Trial Status:

Registered

Date Submitted:

20/01/2006

Date Registered:

25/01/2006

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Public title:

Effects of regular consumption of lupin kernel flour-enriched foods on risk factors for heart disease

ANZCTR registration title:

Effects of regular consumption of lupin kernel flour-enriched foods on risk factors for heart disease in overweight healthy subjects

Secondary ID:

UTN:

Trial acronym:

LKF

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Health condition(s) or problem(s) studied:
Risk factors for heart disease in overweight healthy subjects

Diet and nutrition	Obesity
Condition category:	Condition code:

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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:

None

Comparator / control treatment:

Bread made from refined wheat flour – based on regular commercially available white bread

Control group:

Active

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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:

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

Healthy volunteers?

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.

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Study type:

Interventional

Purpose of the study:

Prevention

Allocation to intervention:

Randomised controlled trial

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):

Computer generated random no placed into opaque sealed envelope

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

Masking / blinding:

Blinded (masking used)

Who is/are masked/blinded:

Assignment:

Parallel

Other design features (specify):

Type of endpoint(s):

Efficacy

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Phase

Phase 1

Anticipated or actual date of first participant enrolement:

1/04/2006

Target sample size:

Recruitment status:

Completed

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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

Primary sponsor:

Government funding body e.g. Department of Health

Name:

Western Australia Department of Agricultural

Address:

Perth, WA

Country:

Australia

Secondary sponsor:

University

Name:

School of Medicine and Pharmacology, University of Western Australia

Address:

Perth, WA

Country:

Australia

Other collaborator:

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Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name:

School of Medicine and Pharmacology

Address:

Country:

Australia

Date of approval:

HREC Number:

Countries of recruitment:

Australia

Brief summary:

Trial website:

Presentations / publication list:

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Contact person for public queries

Name:

Dr Jonathan HODGSON

Address:

School of Medicine and Pharmacology University of Western Australia Royal Perth Hospital GPO Box X2213 Perth WA 6847

Country:

Australia

Tel:

+61 8 92240267

Fax:

+61 8 92240246

Email:

jonathan@cyllene.uwa.edu.au

Contact person for scientific queries

Name:

Ya Ping LEE

Address:

School of Medicine and Pharmacology University of Western Australia Royal Perth Hospital GPO Box X2213 Perth WA 6847

Country:

Australia

Tel:

+61 8 92240344

Fax:

+61 8 92240243

Email:

yplee@meddent.uwa.edu.au

Contact person responsible for updating information

Name:

Address:

Country:

Tel:

Fax:

Email:

Trial Details

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