Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001236583
Ethics application status
Approved
Date submitted
20/08/2015
Date registered
11/11/2015
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Tualang honey on oxidative stress status, inflammation and lipid profiles in chronic smokers
Scientific title
Effects of Tualang honey on oxidative stress status, inflammation and lipid profiles in chronic male smokers
Secondary ID [1] 287318 0
None
Universal Trial Number (UTN)
U1111-1173-3896
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic smokers 295958 0
Condition category
Condition code
Alternative and Complementary Medicine 296235 296235 0 0
Other alternative and complementary medicine
Respiratory 296789 296789 0 0
Other respiratory disorders / diseases
Cardiovascular 296792 296792 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tualang honey supplementation 20 g daily orally for 12 weeks.
Honey is in liquid form packed in a sachet (20 g per sachet).
Honey must be taken alone before meal in the morning.
Participants are required to return the empty sachet to ensure or monitor compliance.
Intervention code [1] 292639 0
Treatment: Other
Intervention code [2] 293087 0
Lifestyle
Comparator / control treatment
Phase 1: Healthy non smoker (without honey).
To compare all the baseline parameters (oxidative stress status, inflammation, lipid profiles) between non-smokers and smokers.
Phase 2: Smoker with no treatment (without honey)
To assess the parameters (oxidative stress status, inflammation, lipid profiles) in smoker without honey and smoker with honey after 12 weeks of the study.
Control group
Active

Outcomes
Primary outcome [1] 295896 0
oxidatives stress status by plasma assays for F2-isoprostanes and total antioxidant status and erythrocyte assays for superoxide dismutase, glutathione peroxidase, catalase enzymes.
Timepoint [1] 295896 0
Baseline and at 12 weeks after intervention
Primary outcome [2] 295897 0
inflammation by plasma assays for TNF-alpha, IL-6 and hsCRP.
Timepoint [2] 295897 0
Baseline and at 12 weeks after intervention
Primary outcome [3] 295898 0
lipid profiles by serum assays for total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) and triglyceride (TG).
Timepoint [3] 295898 0
Baseline and at 12 weeks after intervention
Secondary outcome [1] 316883 0
none
Timepoint [1] 316883 0
none

Eligibility
Key inclusion criteria
For Non-smoker group
- no history of smoking
- no history of exposure to environmental tobacco smoke

For smoker group
- smoke at least 10 cigarettes/day for more than 5 years or 2.5 pack-years
Minimum age
20 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Regular consumption of multivitamins and/or dietary supplements 3 months before participation in the study
- presence of diabetes mellitus, hypertension, hyperlipidemia or cardiovascular diseases
- obese (BMI>30kg/m2)
- taking alcohol
- presence of severe infection

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (Random Allocation Software version 1.0)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation for each group was calculated using Power and Sample Size Calculation Software version 3.0.10. for all parameters with a power of 80% and statistical significance of 0.05. Considering the nonresponse rate of 20%, 36 subjects were recruited for each arm of the study. However, the final number of subjects for each arm was 32 for each arm after excluding the dropped out subjects.
The data were analysed using SPSS version PASW20.
Phase 1: Data were analysed using Independent t-test to compare the difference of baseline or pre-intervention parameters between non-smokers and smokers.
Phase 2: The baseline and changes of parameters after 12 week intervention period in each smoker group (smokers without honey and smokers with honey groups) were analysed by paired t-test and Wilcoxon signed-rank test for normal and non-normal distributed data, respectively. A value of p<0.05 was considered to be statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/09/2012
Date of last participant enrolment
Anticipated
Actual
18/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
64
Recruitment outside Australia
Country [1] 7110 0
Malaysia
State/province [1] 7110 0
Kelantan

Funding & Sponsors
Funding source category [1] 291886 0
University
Name [1] 291886 0
Universiti Sains Malaysia Short Term Grant(Grant Number: 304/PPSP/61312025 and Grant number: 304/PPSP/61312034)
Country [1] 291886 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
Universiti Sains Malaysia, 11800 Gelugor, Penang, Malaysia
Country
Malaysia
Secondary sponsor category [1] 290551 0
None
Name [1] 290551 0
Address [1] 290551 0
Country [1] 290551 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293393 0
Human Research Ethics Committee of Universiti Sains Malaysia
Ethics committee address [1] 293393 0
Ethics committee country [1] 293393 0
Malaysia
Date submitted for ethics approval [1] 293393 0
22/08/2011
Approval date [1] 293393 0
24/11/2011
Ethics approval number [1] 293393 0
JEPeM [243.3.(5) and JEPeM [243.3.(6)

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

Contacts
Principal investigator
Name 59674 0
Dr Mahaneem Mohamed
Address 59674 0
Department of Physiology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia
Country 59674 0
Malaysia
Phone 59674 0
+6097676158
Fax 59674 0
Email 59674 0
[email protected]
Contact person for public queries
Name 59675 0
Mahaneem Mohamed
Address 59675 0
Department of Physiology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia
Country 59675 0
Malaysia
Phone 59675 0
+6097676158
Fax 59675 0
Email 59675 0
[email protected]
Contact person for scientific queries
Name 59676 0
Mahaneem Mohamed
Address 59676 0
Department of Physiology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia
Country 59676 0
Malaysia
Phone 59676 0
+6097676158
Fax 59676 0
Email 59676 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEffects of honey supplementation on inflammatory markers among chronic smokers: A randomized controlled trial.2017https://dx.doi.org/10.1186/s12906-017-1703-6
N.B. These documents automatically identified may not have been verified by the study sponsor.