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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000034538
Acronym
LKF
Enrollment
80
Registered
2006-01-25
Start date
2006-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 o

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.

Sponsors

Western Australia Department of Agricultural
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Otherwise healthy, but overweight, with BMI between 25 and 35 will be recruited. Volunteers will have no history of major chronic disease

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 3, 2026