ANZCTR - Registration

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]

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

Condition category

Condition code

Diet and Nutrition

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]

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]

DNA damage biomarker (chromosome): Cytokinesis block micronucleus assay (CBMN assay) to detect micronucleus frequency in cultured lymphocytes from blood

Timepoint [1]

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]

Change in telomere length in lymphocytes isolated from blood using real time quantitative polymerase chain reaction (qPCR) assay

Timepoint [2]

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]

8-hydroxy-dG (biomarker of oxidative stress to genetic material): anti-body assay using metasystems, using lymphocytes from blood

Timepoint [3]

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]

Concentration of polyphenols in plasma: using HPLC based assay

Timepoint [1]

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]

Blood pressure: measurement of blood pressure by clinical research nurse

Timepoint [2]

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]

Blood Cholesterol: measurement of LDL and HDL in blood using conventional measurement protocol

Timepoint [3]

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]

Blood triglycerides: conventional method to measure concentration of triglycerides in blood

Timepoint [4]

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]

Brain derived neurotropic factor (BDNF) level: Elisa method to measure circulating levels of BDNF in blood (plasma)

Timepoint [5]

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]

Blood glucose: traditional assay to measure blood glucose levels

Timepoint [6]

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]

Insulin: traditional method will be used to measure blood insulin level

Timepoint [7]

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]

Homocysteine: Blood homocysteine levels measurement using conventional assay

Timepoint [8]

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

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]

South Australian Health and Medical Research Institute (SAHMRI) - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

JMB Beverages Pty Ltd

Country [1]

Australia

Primary sponsor type

Government body

Name

CSIRO Health and Biosecurity

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CSIRO Health and Medical Research Human Research Ethics Committee

Ethics committee address [1]

Ecosciences Precinct
Dutton Park
Queensland 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/02/2016

Approval date [1]

06/05/2016

Ethics approval number [1]

05/2016

Summary

Brief summary

Alcohol-removed wines are relevant  to reducing the risk of DNA damage and other alcohol-related pathologies in (i) the foetus in utero and the mother/father for those couples who choose to continue drinking wine before and during pregnancy, (ii) those who habitually exceed current alcohol drinking recommendations and are trying to maintain their social habits, (iii) those who are genetically susceptible because they can not metabolise alcohol properly and/or detoxify its carcinogenic metabolite acetaldehyde (i.e. ALDH2 defect commonly found in Asians), (iv) those who want the health benefit of increased wine phenolic intake without the detrimental effect  of alcohol in wine or the high sugar in grape juice (e.g. diabetics) and (vi) those who want to drink wine phenolics because of the emerging evidence of their protective effects against neurodegeneration and their role as potential  caloric restriction mimetics. The direct benefits of de-alcoholised wine may be particularly relevant to obese individuals because they exhibit higher levels of DNA damage and oxidative stress as well as being at a higher risk of developing diseases associated with increased DNA damage such as cancer, cardiovascular disease and neurodegenerative disorders such as Alzheimer’s disease. 
The main aim of the project is to test whether daily consumption of either 187.5 ml of Eden Vale de-alcoholised Shiraz for 8 weeks followed by consumption of 375.0ml for another 8 weeks prevents age-associated genome pathology and metabolic stress in overweight/obese men and women who are at least 50 years old. The hypothesis we are testing is “Increased consumption of de-alcoholised red wine prevents DNA damage and other biomarkers of ageing in overweight/obese older men and women”.

Trial website

Public notes

Attachments [1]

/AnzctrAttachments/371514-EthicsApproval05_2016Letter060516.doc (Ethics approval)

Contacts

Principal investigator

Name

Prof Michael Fenech

Address

CSIRO Health and Biosecurity
Gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000

Country

Australia

Phone

+61 8 83038880

Email

[email protected]

Contact person for public queries

Name

Varinderpal S Dhillon

Address

CSIRO Health and Biosecurity
Gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000

Country

Australia

Phone

+61 8 83038932

Email

[email protected]

Contact person for scientific queries

Name

Varinderpal S Dhillon

Address

CSIRO Health and Biosecurity
Gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000

Country

Australia

Phone

+61 8 83038932

Email

[email protected]

Trial Review

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