ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1173-3896

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic smokers

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Respiratory

Other respiratory disorders / diseases

Cardiovascular

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]

Treatment: Other

Intervention code [2]

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]

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]

Baseline and at 12 weeks after intervention

Primary outcome [2]

inflammation by plasma assays for TNF-alpha, IL-6 and hsCRP.

Timepoint [2]

Baseline and at 12 weeks after intervention

Primary outcome [3]

lipid profiles by serum assays for total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) and triglyceride (TG).

Timepoint [3]

Baseline and at 12 weeks after intervention

Secondary outcome [1]

none

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Kelantan

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universiti Sains Malaysia Short Term Grant(Grant Number: 304/PPSP/61312025 and Grant number: 304/PPSP/61312034)

Address [1]

Universiti Sains Malaysia, 11800 Gelugor, Penang, Malaysia

Country [1]

Malaysia

Primary sponsor type

University

Name

Universiti Sains Malaysia

Address

Universiti Sains Malaysia, 11800 Gelugor, Penang, Malaysia

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee of Universiti Sains Malaysia

Ethics committee address [1]

Human Research Ethics Committee USM,
Universiti Sains Malaysia,
Health Campus,
16150 Kubang Kerian,
Kelantan,
Malaysia

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

22/08/2011

Approval date [1]

24/11/2011

Ethics approval number [1]

JEPeM [243.3.(5) and JEPeM [243.3.(6)

Summary

Brief summary

Elevated oxidative stress, inflammation and alteration in lipid profiles in smokers have been proposed as among the major factors that contribute to the development of smoking-related cardiovascular disease. However, the possible beneficial effect of Tualang honey that has antioxidant, anti-inflammatory and antilipid properties among smokers has yet been reported. The aims of this study, therefore, to determine the effects of Tualang Honey supplementation on oxidative stress markers, inflammatory markers and lipid profiles in chronic smokers.

Trial website

Trial related presentations / publications

1. ‘Honey Supplementation Improves Erythrocyte Antioxidant Enzyme Activities among Chronic Smokers’ presented at International Conference on Medical & Health Sciences (ICMHS) on 22nd May2013.
2. ‘Honey Supplementation Improves Oxidative Stress Status among Chronic Smokers’ presented at 27th Scientific Meeting of Malaysian Pharmacology and Physiology 2013 (MSPP2013) on 7th September 2013.
3. ‘Honey Supplementation Improves Lipid Profile Among Chronic Smokers’ presented at International Conference on
Natural Products 2014 (ICNP2014) on 18-19th March 2014.
4. ‘Effects of Tualang Honey on Inflammatory Markers among Chronic Smokers’ presented at International Conference on Natural Products 2014 (ICNP2014) on 18-19th March 2014.

Public notes

Contacts

Principal investigator

Name

Dr Mahaneem Mohamed

Address

Department of Physiology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia

Country

Malaysia

Phone

+6097676158

Fax

mahaneem@usm.my

Contact person for public queries

Name

Mahaneem Mohamed

Address

Department of Physiology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia

Country

Malaysia

Phone

+6097676158

Fax

mahaneem@usm.my

Contact person for scientific queries

Name

Mahaneem Mohamed

Address

Department of Physiology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia

Country

Malaysia

Phone

+6097676158

Fax

mahaneem@usm.my

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

Source	Title	Year of Publication	DOI
Embase	Effects of honey supplementation on inflammatory markers among chronic smokers: A randomized controlled trial.	2017	https://dx.doi.org/10.1186/s12906-017-1703-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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