None listed
Conditions
Brief summary
This trial investigates the impact of daily consumption of two apples or two pears on cardiometabolic disease risk factors, biochemical (fingerprints) changes, and microbiome function. Adult volunteers at risk of developing cardiometabolic disease are eligible for this study. Participants will be randomly assigned to consume apples for 8 weeks, followed by a 4-week washout period, and then another 8 weeks of pears, or vice versa. It is hoped that this study will support improved health outcomes from consuming apples or pears.
Interventions
The trial assesses the impact of consuming two high-polyphenol apples on cardiometabolic disease risk factors and microbiome function. It will take place at the Harry Perkins Medical Institute (South). This randomized, crossover dietary intervention study utilizes high-risk individuals. Each participant will consume either two high-polyphenol apples or two low-polyphenol pears (as a control) daily for 8 weeks, with a minimum 4-week washout period in between. Volunteers are to adhere to their usu
The trial assesses the impact of consuming two high-polyphenol apples on cardiometabolic disease risk factors and microbiome function. It will take place at the Harry Perkins Medical Institute (South). This randomized, crossover dietary intervention study utilizes high-risk individuals. Each participant will consume either two high-polyphenol apples or two low-polyphenol pears (as a control) daily for 8 weeks, with a minimum 4-week washout period in between. Volunteers are to adhere to their usual diet but are required to abstain from probiotics/prebiotics and any additional apples or pears intake, including whole fruits, juices, or dried fruits. Habitual diet will be monitored using Intake24, an online validated tool for recording food intake. This self-reported monitoring will occur prior to the start of the study (baseline), and at week 4 and 8 at each intervention period. In addition, volunteers are asked to provide evidence of daily food waste using a time stamped photo.
Sponsors
Murdoch University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
• Adult between 18 – 70 years. • Body mass index is between 20 -30 kg/m2. • High-risk of cardiometabolic disease group based on an AUSDRISK score of 9 or higher, with at least one risk factor other than age or gender
Exclusion criteria
• Medical history of heart disease and diabetes mellitus, kidney, liver diseases, pancreatic diseases or gastrointestinal disorders. • Currently taking medication for hyperlipidaemia, hypertension, gastrointestinal motility issues, inflammation or immunosuppressants. • Pregnancy (current or planned), or lactation. • History of alcohol misuse. • Antibiotics intake <2 months ago. • Food/vitamin supplement use (e.g. fish oil) unless willing to stop for 1 month before study commencement. • Habitual intake of at least 1 apple or pear/day. • On a special diet e.g. vegetarian and vegan diet or planned weight loss regimen.
Outcome results
None listed