Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001736134p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2019
Date registered
9/12/2019
Date last updated
9/06/2021
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of a New Zealand berry fruit product on lung health and immunological status of individuals living in urban China
Scientific title
The New Zealand-China Berry Lung Health (EDIBLE) study
Secondary ID [1] 299888 0
None
Universal Trial Number (UTN)
U1111-1236-1933
Trial acronym
EDIBLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory disease 315338 0
Systemic inflammation 315339 0
Condition category
Condition code
Public Health 313639 313639 0 0
Other public health
Diet and Nutrition 313640 313640 0 0
Other diet and nutrition disorders
Respiratory 313746 313746 0 0
Normal development and function of the respiratory system
Inflammatory and Immune System 313747 313747 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316187 0
Treatment: Other
Comparator / control treatment
The main intervention beverage (arm 1) will consist of one serving (30 mL) of BerriQi® daily, for a total of 28 days.

The control beverage (arm 2) is the heat-treated version of the main intervention beverage (BerriQi). It has undergone heat inactivation to deplete its anthocyanins, which should render it inactive/less active relative to the main intervention. It is similar in all other physical and visual aspects to the main intervention beverage (i.e. BerriQi). Slight flavour and colour differences are externally unrecognisable to participants within this parallel arm study design. To blind all study coordinators and participants, the two products will be dispensed in two identical bottles with either a ‘black’ or ‘white’ label.
Control group
Placebo

Outcomes
Primary outcome [1] 322080 0
This study will evaluate the following primary outcome measures at baseline (day 0), mid-intervention (day 14) and at the end of the intervention (day 28):

Changes in lung function evaluated by spirometry as forced expiratory volume 1:forced vital capacity (FEV1/FVC) ratios.
(i.e. ratio of: the volume of air that has been exhaled at the end of the first second of forced expiration [FEV1] to forced vital capacity [FVC]).

This is a calculated ratio that measures how an individual inhales or exhales volumes of air as a function of time, and it provides an indicative clinical measure of how well an individual’s breathing capabilities are
Timepoint [1] 322080 0
FEV1/FVC ratios will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [1] 377257 0
Changes in plasma levels of C-reactive protein (CRP), as measured by enzyme-linked immunosorbent assays.
Timepoint [1] 377257 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [2] 377537 0
Changes in the composition, functional and immunometabolic phenotypes of peripheral blood mononuclear cells (PBMC) from blood
Timepoint [2] 377537 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [3] 377538 0
Changes in the plasma metabolome
Timepoint [3] 377538 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [4] 377539 0
Changes in gut microbiota composition, assessed by metagenomics analysis on faecal samples
Timepoint [4] 377539 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [5] 377540 0
Changes in skin elasticity (measured using a non-invasive multi-parameter skin analysis system, such as the Cortex DermaLab combo, or equivalent)
Timepoint [5] 377540 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [6] 377541 0
Changes in glycated haemoglobin (HbA1c) levels, which will be measured using an accredited, clinical-grade glycohaemoglobin affinity high performance liquid chromatography device. A small volume of venous whole blood (typically less than 1 milliliter, or a fraction (0.07) of a tablespoon) is required for this assay.
Timepoint [6] 377541 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [7] 377542 0
Changes in body mass index (BMI). BMI is calculated by dividing the weight of the participant in kg (as determined using an electronic weighing scale) by the square of the height in meters (which will be determined using a portable, or fixed, height measuring board; the participant will be asked to stand feet together, heels against the board and knees straight, looking straight ahead; the measurement arm will be gently moved down onto the head of the participant and the height will be read).
Timepoint [7] 377542 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [8] 377663 0
Changes in plasma levels of Interleukin-6 (IL-6), as measured by enzyme-linked immunosorbent assays.
Timepoint [8] 377663 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [9] 377664 0
Changes in plasma levels of soluble vascular adhesion molecule-1 (sVCAM1), as measured by enzyme-linked immunosorbent assays.
Timepoint [9] 377664 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [10] 377665 0
Changes in fasting blood glucose
Timepoint [10] 377665 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [11] 377666 0
Changes in skin trans-epidermal water loss (TEWL; measured using a non-invasive multi-parameter skin analysis system, such as the Cortex DermaLab combo, or equivalent)
Timepoint [11] 377666 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [12] 377667 0
Changes in skin pH (measured using a non-invasive multi-parameter skin analysis system, such as the Cortex DermaLab combo, or equivalent)
Timepoint [12] 377667 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [13] 377668 0
Changes in weight (as measured using an electronic weighing scale)
Timepoint [13] 377668 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [14] 377669 0
Changes in waist circumference. Waist circumference will be measured just above the iliac crest, patient standing and after exhale, using a standard measuring tape (which does not stretch).
Timepoint [14] 377669 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase
Secondary outcome [15] 377670 0
Changes in waist-to-hip (WHR) ratio. Waist circumference will be measured just above the iliac crest, patient standing and after exhale, using a standard measuring tape (which does not stretch). Hip circumference will be measured in a similar fashion, but around the widest portion of the buttocks. The ratio will be determined by dividing the waist circumference by the hip circumference (expressed in the same units).
Timepoint [15] 377670 0
All the above-mentioned secondary outcomes will be evaluated at:
(i) baseline (day 0),
(ii) midpoint (day 14), &
(iii) endpoint (day 28)
of the 4-week dietary intervention phase

Eligibility
Key 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
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID19 pandemic
Date of first participant enrolment
Anticipated
16/12/2019
Actual
Date of last participant enrolment
Anticipated
31/01/2020
Actual
Date of last data collection
Anticipated
2/03/2020
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 22146 0
China
State/province [1] 22146 0
Nanjing, Jiangsu Province

Funding & Sponsors
Funding source category [1] 304345 0
Government body
Name [1] 304345 0
The New Zealand High Value Nutrition (itself funded by the New Zealand Ministry of Business, Innovation, and Employment)
Country [1] 304345 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Malaghan Institute of Medical Research
Address
Gate 7, Victoria University, Kelburn Parade
PO Box 7060
Newtown
Wellington 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 304597 0
University
Name [1] 304597 0
China Pharmaceutical University
Address [1] 304597 0
China Pharmaceutical University
No. 24 Tongjiaxiang, Nanjing
Jiangsu Province, P.R. China, 210009
Country [1] 304597 0
China

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304797 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 304797 0
Ethics committee country [1] 304797 0
New Zealand
Date submitted for ethics approval [1] 304797 0
27/11/2019
Approval date [1] 304797 0
Ethics approval number [1] 304797 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98238 0
Dr Olivier Gasser
Address 98238 0
Malaghan Institute of Medical Research
Gate 7, Victoria University
Kelburn Parade,
6242 Wellington
New Zealand
Country 98238 0
New Zealand
Phone 98238 0
+6444996914
Fax 98238 0
Email 98238 0
[email protected]
Contact person for public queries
Name 98239 0
Olivier Gasser
Address 98239 0
Malaghan Institute of Medical Research
Gate 7, Victoria University
Kelburn Parade,
6242 Wellington
New Zealand
Country 98239 0
New Zealand
Phone 98239 0
+6444996914
Fax 98239 0
Email 98239 0
[email protected]
Contact person for scientific queries
Name 98240 0
Olivier Gasser
Address 98240 0
Malaghan Institute of Medical Research
Gate 7, Victoria University
Kelburn Parade,
6242 Wellington
New Zealand
Country 98240 0
New Zealand
Phone 98240 0
+6444996914
Fax 98240 0
Email 98240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification, will be made available upon publication.
We intend to publish all results. However, these results may be segmented into several publications.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access the data.
Available for what types of analyses?
Any analyses
How or where can data be obtained?
Data will be available through the publisher of the research articles.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.