None listed
Conditions
Brief summary
Aim To investigate the effects of regular consumption of foods enriched in LKF during and following energy restriction on body composition and heart disease risk factors in overweight individuals. Hypotheses Regular consumption of foods enriched in protein and fibre derived from LKF during energy restriction will enhance the loss of body weight and body fat mass and result in greater improvements in heart disease risk factors in overweight individuals Regular consumption of foods enriched in protein and fibre derived from LKF will improve the long-term maintenance of weight loss and cardiovascular health benefits in overweight individuals
Interventions
High (25-50% incorporation rate) and Low (<1%) lupin kernel flour fortified foods provided and consumed for a period of 12 months. In the high lupin group we are aiming for 60g per day of lupin kernel flour from the foods, contributing approximately an additional 25 grams of protein and 15 grams of fibre per day. In the low lupin (placebo) group we are aiming for <1g per day of lupin kernel flour from the foods, contributing negligible protein and fibre from lupin. This should result in a diffe
High (25-50% incorporation rate) and Low (<1%) lupin kernel flour fortified foods provided and consumed for a period of 12 months. In the high lupin group we are aiming for 60g per day of lupin kernel flour from the foods, contributing approximately an additional 25 grams of protein and 15 grams of fibre per day. In the low lupin (placebo) group we are aiming for <1g per day of lupin kernel flour from the foods, contributing negligible protein and fibre from lupin. This should result in a difference of >20g protein and >10g of fibre per day between the low lupin and high lupin groups attributed to the difference in incorporation of lupin kernel flour. Dietetic weight management advice for the first 4 months of the study for both groups.
Sponsors
State Government of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: Men and women 20 to 70 years old, Body Mass Index (BMI) 27-35kg/m2= Weight (in kilograms)/ height² (in meters) Non-smokers Healthy
Exclusion criteria
-current or recent (<12 months) smoking -body mass index < 27 or > 35 kg/m2, -history of cardiovascular or peripheral vascular disease, -diagnosed diabetes, and non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 6.0 mmol/L, -treated hypertension or treated dyslipidaemia -history of asthma, renal, liver or gastrointestinal disease, or gout, -a psychiatric illness, -other major illnesses such as cancer, -systolic blood pressure > 150 mm Hg or diastolic blood pressure >95mm Hg, -total cholesterol > 6.0 mmol/L or triglycerides > 2.0 mmol/L, -a change in drug therapy within the previous 3 months, or the likelihood that drug therapy would change during the study, -women who are pregnant or intend to become pregnant, -history of severe food allergies especially Lupin, -current or recent (within previous 6 months) significant weight loss or gain (> 6% of body weight), -alcohol intake > 140 g per wk for women and > 280 g per wk for men, -individuals who travel and/or eat away from home regularly, -inability or unwillingness to consume foods provided.
Outcome results
None listed