None listed
Conditions
Brief summary
We hypothesise that undigested bioactive components of apples (fibre and polyphenols) can improve gastrointestinal health by enhancing the elimination of waste, the gut environment, and structure and function of the microbiome. The proposed study will be a randomised, controlled, cross-over clinical intervention study. The cross-over design will be completed using three interventions of two apples per day. There will be three different varieties (Granny Smith, Jazz and Dazzle) of commercially available apples. The study duration is a total of 17 weeks; 2-week lead in, 3-week intervention. 2-week washout, 3-week intervention, 2-week washout, 3-week intervention and final 2-week follow-up. The primary outcome measure will be quantification of CSBM (complete spontaneous bowel movement). Secondary outcome measures will include Daily Bowel Habit Diary, Three-day Food Diary, Fructan Food Frequency Questionnaire and Gastrointestinal Symptom Rating Scale.
Interventions
This is a 17-week cross-over study, which includes three intervention periods of three weeks each, separated by 2-week wash-out periods.
During each intervention period, participants will consume a different variety of apple. Dazzle and Jazz (red apples) will be compared to Granny Smith (green apple). The red varieties have higher total concentrations of polyphenols and different polyphenol profiles from the green apple.
During each of the three intervention periods, participants will eat 2 ap
This is a 17-week cross-over study, which includes three intervention periods of three weeks each, separated by 2-week wash-out periods. During each intervention period, participants will consume a different variety of apple. Dazzle and Jazz (red apples) will be compared to Granny Smith (green apple). The red varieties have higher total concentrations of polyphenols and different polyphenol profiles from the green apple. During each of the three intervention periods, participants will eat 2 apples per day for three weeks. At the end of each trial period, participants will return uneaten apples to the trial coordinators as a measure of compliance. Participants will also be directly asked whether or not they adhered to the protocol.
Sponsors
Plant and Food Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adults between ages of 18-65 years inclusive with a BMI between 18-35 kg/m2.
Exclusion criteria
Alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, occult blood in stools, anaemia), anal fissures, bleeding haemorrhoids, and family history of Gastrointestinal (GI) cancer or Inflammatory Bowel Disease (IBD). Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal cord injury, stroke). Fasting blood glucose greater than 6.0 mmol/l Women who are pregnant, breastfeeding or planning a pregnancy during the study period Allergies to apple, alder or birch pollen and latex Screening blood test results outside of the normal range which are deemed to be clinically significant
Outcome results
None listed