None listed
Conditions
Brief summary
The World Health Organization estimates that 90% of the world’s population is exposed to airborne particulate matter (PM), established drivers of systemic inflammation. The purpose of this study is to investigate whether daily intake, as part of the habitual daily diet, for four weeks, of a New Zealand berry fruit product, made from natural boysenberries and apples, previously shown to benefit lung health in animal models of lung inflammation, can improve an aspect of lung health in adults living in an urban area in China (Nanjing, Jiangsu). Lung health will be assessed using spirometry, evaluated as the ratio of the volume of air that can be forced from the lungs in 1 second (Forced Expiratory Volume 1 or FEV1), divided by the total forced volume of the lungs (Forced Vital Capacity or FVC).
Interventions
Study design: This study is a double-blind, controlled, parallel arm (two arms) study
Arm 1: Commercially-available Apple and Boysenberry beverage (BerriQi)
Arm 2: Control beverage (Heat-treated version of BerriQi; depleted in anthocyanins)
Intervention details:
Dose: 30 mL of BerriQi or Control beverage, daily for 4 weeks (28 days)
Duration: 6 weeks
(I) a 2-week lead in period for screening, recruitment and randomisation, followed by
(II) a 4-week intervention period
Mode of administration: O
Study design: This study is a double-blind, controlled, parallel arm (two arms) study Arm 1: Commercially-available Apple and Boysenberry beverage (BerriQi) Arm 2: Control beverage (Heat-treated version of BerriQi; depleted in anthocyanins) Intervention details: Dose: 30 mL of BerriQi or Control beverage, daily for 4 weeks (28 days) Duration: 6 weeks (I) a 2-week lead in period for screening, recruitment and randomisation, followed by (II) a 4-week intervention period Mode of administration: Oral (beverage form) Important notes: 1. Participants can maintain their dietary habits throughout the 4 week intervention period. Participants are therefore allowed to consume other beverages throughout the intervention. 2. Participants will be provided with the beverage, free of charge, during the intervention period only. 3. At every visit, participants will be asked to return all used and unused bottles of the intervention products (BerriQi or control beverage). Adherence/compliance will be assessed by determining the proportion of unused bottles at each visit.
Sponsors
Malaghan Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all the following criteria: a. Male of female b. Chinese ethnicity c. Age is between 30 and 70 years d. Body mass index (BMI) between 18 and 35 kg/m2 e. Self-reported as healthy f. Catch public transport daily or occupationally exposed to airborne particulate emission for at least 2 hours on a daily basis
Exclusion criteria
Participants with at least one of the following criteria will be excluded: a. BMI < 18 kg/m2 or BMI > 35 kg/m2 b. Chronic obstructive pulmonary disease (COPD), or other chronic respiratory condition (including sleep apnoea) c. Cardiovascular disease (CVD), including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease; SBP > 160 mmHg and/or DBP > 100 mmHg (with or without hypertensive medication) d. Type 1 or type 2 diabetes mellitus e. Chronic renal impairment; liver disease e.g. cirrhosis; prior bariatric surgery, neurological, psychiatric, or musculoskeletal disease f. Autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD), celiac disease, pancreatitis or other malabsorption condition. g. Malignancy h. Recent prior (previous 4 weeks) or current use of antibiotics i. Recent prior (previous 4 weeks) or current respiratory infection j. Current or prior eating disorder (e.g. anorexia nervosa, bulimia) k. Food allergy or intolerance that would compromise compliance with the study protocol, including berry fruits and apples l. Pregnant or breastfeeding; or intent to become pregnant during study duration m. Current participation in another clinical intervention study n. Inability to provide written informed consent
Outcome results
None listed