None listed
Conditions
Brief summary
The primary aim of this study is to determine if short-term regular apple intake (4 weeks) results in a sustained benefit on measures of vascular health in individuals with at least one risk factor for cardiovascular disease.
Interventions
A randomised, controlled, cross-over designed trial will be performed. The total duration of the trial will be 16 weeks. Each participant will complete 2 intervention periods of 4 weeks each in random order. These will be separated by a 4 week washout period. In addition, the first 4 week intervention period will be preceded by a 4 week run-in period. The two 4 week intervention periods will correspond to:
1. Active – consumption of 200 g of fresh apple (approximately one large apple) blended wi
A randomised, controlled, cross-over designed trial will be performed. The total duration of the trial will be 16 weeks. Each participant will complete 2 intervention periods of 4 weeks each in random order. These will be separated by a 4 week washout period. In addition, the first 4 week intervention period will be preceded by a 4 week run-in period. The two 4 week intervention periods will correspond to: 1. Active – consumption of 200 g of fresh apple (approximately one large apple) blended with water each day for 4 weeks (total fluid volume 400 ml) 2. Control – consumption 400 ml of water + 25 g maltodextrin each day for 4 weeks. Participants will attend the School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Unit located in the Medical Research Foundation Building, Level 3, Rear 50 Murray St, Perth. To monitor adherence, participants will be asked to record intervention intake in a diary that will be provided. Participants will also be asked to return unused maltodextrin powder.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Men and women will be aged between 18 and 75 years Volunteers are included in the study if they have at least one of the following: elevated blood pressure (120 mmHg< systolic BP <150 mmHg), moderately elevated blood sugar levels (5.6 mmol/L< glucose <6.5 mmol/L), raised fasting cholesterol (5 mmol/L < total cholesterol <8 mmol/L) or central obesity (measured by waist circumference; men >94 cm; women >80 cm).
Exclusion criteria
• Body mass index <18 or >40 kg/m2 • Systolic blood pressure greater than or equal to 150 mmHg • Diastolic BP greater than or equal to 100 mmHg • Diagnosed diabetes • Non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 6.5 mmol/L • Current or recent (<12 months) smoking • History of cardiovascular or peripheral vascular disease • Use of blood pressure lowering or cholesterol lowering medication • Psychiatric illness or other major illnesses such as cancer • Alcohol intake >210 g per week for women and >280 g per week for men • Current or recent (within previous 6 months) significant weight loss or gain (>6% of body weight) or actively trying to lose weight • Women who were lactating, pregnant or wishing to become pregnant during the study. • Inability to attend clinic/office visits • Use of antibiotics (within previous 2 months) • current or recent (<6 months) smoking • Inability or unwillingness to follow the study protocol • Systolic blood pressure less than or equal to 100 mmHg • Diastolic BP less than or equal to50 mmHg
Outcome results
None listed