ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000036617

Ethics application status

Approved

Date submitted

30/12/2013

Date registered

16/01/2014

Date last updated

23/03/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of Pakistani and American almonds on good cholesterol

Scientific title

Comparison of high-density lipoprotein (HDL) raising efficacy of Pakistani and American almonds in Coronary artery disease patients with sub-optimal HDL

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1151-7230

Trial acronym

CHEPAA

Linked study record

Health condition

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

Coronary Artery Disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: No intervention
Arm 2: Pakistani almonds (10 gm per day for 12 weeks)
Arm 3: American almonds (10 gm per day for 12 weeks)

The content of different almond varieties vary which might or might not lead to difference in biological activity.

Total duration of intervention is 12 weeks.

Regular phone calls (twice a week) were made to monitor compliance.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No treatment

Control group

Active

Outcomes

Primary outcome [1]

Serum HDL will be estimated using automated analyzer roche c-111

Timepoint [1]

six week

Secondary outcome [1]

Serum HDL will be estimated using automated analyzer roche c-11

Timepoint [1]

twelve week

Secondary outcome [2]

Lipid profile will be done using automated analyzer roche c-11

Timepoint [2]

six and twelve week

Eligibility

Key inclusion criteria

Coronary artery disease with LDL < = 100 mg/dl and HDL < = 40 mg/dl (male) or < = 50 mg/dl (female)

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

All patients recently presented with Acute Myocardial infarction (within last 5 weeks).
Patients with nut allergy
Patients already taking regular nuts
Regular Smokers

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)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block randomization

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

Data will be entered and analyzed on SPSS version 17.0 and Graph pad prism. Means for quantitative data and frequencies, proportions and percentages for categorical data will be calculated. For quantitative data, paired and unpaired students t-test will be used to compare the means within and between groups respectively. One way ANOVA will be used to compare the means between various groups followed by Tukey’s and Dunett’s tests for multiple comparisons. For categorical data, chi-square will be used to compare differences between groups. For randomized controlled trial if the data is not normally distributed, to compare means, Wilcoxin signed rank sum test will be used for paired data and Mann Whitney U test for unpaired data. P-values less than 0.05 will be considered statistically significant (Confidence interval of 95%).
Sample size was calculated, taking the prevalence of low HDL 66%, 95% level of confidence and 8% (0.08) bound on the error of estimation.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2013

Actual

11/02/2013

Date of last participant enrolment

Anticipated

31/05/2013

Actual

28/06/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

119

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Karachi, Sindh

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Higher Education Commission - Indigenous PhD Scholarship

Address [1]

Stadium road, Karachi 74800, Pakistan

Country [1]

Pakistan

Primary sponsor type

University

Name

Aga Khan University

Address

Stadium Road, Karachi 74800

Country

Pakistan

Secondary sponsor category [1]

Individual

Name [1]

Dr Anwar ul Hassan Gilani

Address [1]

Aga Khan University, Stadium road, Karachi 74800

Country [1]

Pakistan

Other collaborator category [1]

Individual

Name [1]

Dr. Fateh Ali Tipoo Sultan

Address [1]

Aga Khan University, Stadium road, Karachi 74800

Country [1]

Pakistan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Review Committee

Ethics committee address [1]

Aga Khan University, Stadium Road Karachi 74800

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

01/06/2012

Approval date [1]

04/01/2013

Ethics approval number [1]

2230-Med-ERC-12

Summary

Brief summary

Coronary artery disease patients with normal lipids and below-normal HDL will be recruited in one of the three arms. They will be given either Pakistani or american almonds or no intervention if they are randomized in the control group. Blood will be drawn at baseline, six and twelve weeks for lipid profiling. HDL-raising efficacy of almonds and comparison of the two almond varieties will be analyzed

Trial website

Trial related presentations / publications

Humaira jamshed, Fateh Ali Tipoo Sultan, Romaina Iqbal, Anwar-ul-Hassan Gilani. Dietary Almonds Increase Serum HDL Cholesterol in Coronary Artery Disease Patients in a Randomized Controlled Trial.. J Nutr 2015;145:2287–92.

Public notes

Contacts

Principal investigator

Name

Prof Dr. Anwar ul hassan Gilani

Address

Aga Khan University, Stadium Road, Karachi 74800

Country

Pakistan

Phone

+92 21 34864571

Fax

[email protected]

Contact person for public queries

Name

Humaira Nasir

Address

Aga Khan University, Stadium Road, Karachi 74800

Country

Pakistan

Phone

+92 21 34864493

Fax

[email protected]

Contact person for scientific queries

Name

Humaira nasir

Address

Aga Khan University, Stadium Road, Karachi 74800

Country

Pakistan

Phone

+92 21 34864493

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Dietary Almonds Increase Serum HDL Cholesterol in Coronary Artery Disease Patients in a Randomized Controlled Trial1-3.	2015	https://dx.doi.org/10.3945/jn.114.207944
Embase	Almond supplementation reduces serum uric acid in coronary artery disease patients: A randomized controlled trial.	2016	https://dx.doi.org/10.1186/s12937-016-0195-4

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

Trial Review

Documents added manually

Documents added automatically