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Trial registered on ANZCTR


Registration number
ACTRN12616001330437
Ethics application status
Approved
Date submitted
19/09/2016
Date registered
23/09/2016
Date last updated
23/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of consumption of de-alcoholised wine on markers of healthy ageing in overweight/obese adults
Scientific title
Efficacy of Eden Vale Shiraz de-alcoholised wine for improving biomarkers of ageing in overweight/obese subjects
Secondary ID [1] 290173 0
NONE
Universal Trial Number (UTN)
U1111-1187-7865
Trial acronym
DAW
Linked study record
NONE

Health condition
Health condition(s) or problem(s) studied:
Overweight or obese 300313 0
Condition category
Condition code
Diet and Nutrition 300178 300178 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the project is to test whether daily consumption of de-alcoholised Shiraz red wine improves indicators of healthy ageing in overweight/obese men and women who are at least 50 years old. The intervention will be conducted over a period of 16 weeks and will test two doses of wine (187.5ml and 375.0ml daily). In the first eight weeks, participants will drink 187.5ml wine daily. Then the same participants will drink 375.0ml in the next eight weeks. The participants will be required to provide blood samples at the start of trial, after 8 weeks and at the end of 16 weeks. The effects of the de-alcoholised red wine will be compared to that of drinking water only. Participants will be randomly allocated to either consume the de-alcoholised wine or water. Blood, saliva and cells from the inside of the mouth will be collected on six occasions during the intervention. The tissue samples will be used to determine molecular biomarkers of ageing. Cognitive function and blood pressure will also be measured.

After every 4 weeks, the participants will submit the proof of empty bottles electronically.
Intervention code [1] 295930 0
Treatment: Other
Comparator / control treatment
The effects of the consumption of de-alcoholised red wine will be compared to that of drinking water only.
Control group
Active

Outcomes
Primary outcome [1] 299662 0
DNA damage biomarker (chromosome): Cytokinesis block micronucleus assay (CBMN assay) to detect micronucleus frequency in cultured lymphocytes from blood
Timepoint [1] 299662 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Primary outcome [2] 299663 0
Change in telomere length in lymphocytes isolated from blood using real time quantitative polymerase chain reaction (qPCR) assay
Timepoint [2] 299663 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Primary outcome [3] 299675 0
8-hydroxy-dG (biomarker of oxidative stress to genetic material): anti-body assay using metasystems, using lymphocytes from blood
Timepoint [3] 299675 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Secondary outcome [1] 327775 0
Concentration of polyphenols in plasma: using HPLC based assay
Timepoint [1] 327775 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Secondary outcome [2] 327791 0
Blood pressure: measurement of blood pressure by clinical research nurse
Timepoint [2] 327791 0
Blood pressure will be measured at every time point (3 visits): baseline (start), after 8 weeks (mid point) and 16 weeks (end of the trial)
Secondary outcome [3] 327792 0
Blood Cholesterol: measurement of LDL and HDL in blood using conventional measurement protocol
Timepoint [3] 327792 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Secondary outcome [4] 327793 0
Blood triglycerides: conventional method to measure concentration of triglycerides in blood
Timepoint [4] 327793 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Secondary outcome [5] 327794 0
Brain derived neurotropic factor (BDNF) level: Elisa method to measure circulating levels of BDNF in blood (plasma)
Timepoint [5] 327794 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Secondary outcome [6] 327795 0
Blood glucose: traditional assay to measure blood glucose levels
Timepoint [6] 327795 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Secondary outcome [7] 327796 0
Insulin: traditional method will be used to measure blood insulin level
Timepoint [7] 327796 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.
Secondary outcome [8] 327797 0
Homocysteine: Blood homocysteine levels measurement using conventional assay
Timepoint [8] 327797 0
Each participant will be required to provide samples at the start of the intervention trial, after 8 weeks and at the conclusion of the trial (16 weeks). During each visit, samples will be collected at base line (fasting samples) and 90 minutes after consuming either de-alcoholised wine (intervention) or water.

Eligibility
Key inclusion criteria
Overweight or obese with a BMI 25-35 Kg/m2
Men and women aged 50 years or older
Healthy (no sign of any underlying disease such as diabetes)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current history of therapy for cardiovascular disease, blood pressure, diabetes, cancer, dementia or other life-threatening diseases
who are smokers
who regularly consume supplements rich in polyphenols

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)
Randomization by computer generated software
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Efficacy
Statistical methods / analysis
Twenty five subjects will undergo intervention with de-alcoholised Shiraz wine and twenty five with water only as controls. Both groups will be matched for age, gender, blood pressure and BMI. The statistical power estimate is based on the main outcome measure which is micronucleus frequency in lymphocytes (a biomarker of DNA damage previously shown to be reduced following red wine consumption). The power-estimates for effects on base-line and radiation-induced micronucleus frequency are described below.
Base-line Micronucleus Frequency
Using data from previous trials conducted in our lab) the mean micronucleus frequency (per 1000 binucleated cells) and standard deviation for healthy adults aged 50-70 years is 26.8 and 14.2 respectively. The following are the power estimates based on the above mean and SD:
Minimum difference detectable at p = 0.05 (one-tailed) Effect size relative to mean base-line MN frequency
90% power 8.5 32%
80% power 7.2 27%

Radiation-Induced Micronucleus Frequency using data from previous study, the mean micronucleus frequency (per 1000 binucleated cells) induced by 1.5Gy X-rays and standard deviation for healthy adults aged 65-75 years is 220 and 30 respectively. The following are the power estimates based on the above mean and SD:
Minimum difference detectable at p = 0.05 (one-tailed), effect size relative to mean of MN frequency induced by 1.5Gy X-rays
90% power 17.9 8%
80% power 15.2 7%

Parametric statistical methods will be used for biomarkers exhibiting Gaussian distribution. Non-parametric methods will be employed to analyse the results for biomarkers that were not Gaussian in their distribution. Paired t-test or Wicoxon-matched pairs test will be used to (i) compare the biomarker differences between the base-line and post-intervention results within each treatment group and (ii) compare the differences between the effect of wine and water (i.e. the difference between treatments for their effects on biomarkers measured as the change in the post-intervention result relative to the base-line result, measured by subtraction). Correlation analysis will be performed by Spearman’s or Pearson’s test depending on whether the biomarker data were Gaussian or non-Gaussian in their distribution. Two way analysis of variance tests will also be performed when required to assess interaction effects of two variables (e.g. treatment by time, gender by treatment). All P values were for 2-tailed tests unless otherwise stated. Statistical tests were performed using Prism 6.0 (Graphpad Inc., USA) and SPSS (IBM SPSS version 22).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2016
Actual
Date of last participant enrolment
Anticipated
10/02/2017
Actual
Date of last data collection
Anticipated
30/11/2017
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6701 0
South Australian Health and Medical Research Institute (SAHMRI) - Adelaide
Recruitment postcode(s) [1] 14338 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 294540 0
Commercial sector/Industry
Name [1] 294540 0
JMB Beverages Pty Ltd
Country [1] 294540 0
Australia
Primary sponsor type
Government body
Name
CSIRO Health and Biosecurity
Address
Gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000
Country
Australia
Secondary sponsor category [1] 293411 0
None
Name [1] 293411 0
Address [1] 293411 0
Country [1] 293411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295977 0
CSIRO Health and Medical Research Human Research Ethics Committee
Ethics committee address [1] 295977 0
Ethics committee country [1] 295977 0
Australia
Date submitted for ethics approval [1] 295977 0
12/02/2016
Approval date [1] 295977 0
06/05/2016
Ethics approval number [1] 295977 0
05/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1119 1119 0 0
/AnzctrAttachments/371514-EthicsApproval05_2016Letter060516.doc (Ethics approval)

Contacts
Principal investigator
Name 69114 0
Prof Michael Fenech
Address 69114 0
CSIRO Health and Biosecurity
Gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000
Country 69114 0
Australia
Phone 69114 0
+61 8 83038880
Fax 69114 0
+61 8 83038899
Email 69114 0
michael.fenech@csiro.au
Contact person for public queries
Name 69115 0
Varinderpal S Dhillon
Address 69115 0
CSIRO Health and Biosecurity
Gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000
Country 69115 0
Australia
Phone 69115 0
+61 8 83038932
Fax 69115 0
+61 8 83038899
Email 69115 0
varinderpal.dhillon@csiro.au
Contact person for scientific queries
Name 69116 0
Varinderpal S Dhillon
Address 69116 0
CSIRO Health and Biosecurity
Gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000
Country 69116 0
Australia
Phone 69116 0
+61 8 83038932
Fax 69116 0
+61 8 83038899
Email 69116 0
varinderpal.dhillon@csiro.au

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No Supporting Document Provided



Results publications and other study-related documents

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