Trial Review

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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] 283823 0
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 290800 0
Condition category
Condition code
Cardiovascular 291166 291166 0 0
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] 288510 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 291155 0
Serum HDL will be estimated using automated analyzer roche c-111
Timepoint [1] 291155 0
six week
Secondary outcome [1] 306151 0
Serum HDL will be estimated using automated analyzer roche c-11
Timepoint [1] 306151 0
twelve week
Secondary outcome [2] 306152 0
Lipid profile will be done using automated analyzer roche c-11
Timepoint [2] 306152 0
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?
No
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] 5705 0
Pakistan
State/province [1] 5705 0
Karachi, Sindh

Funding & Sponsors
Funding source category [1] 288483 0
Government body
Name [1] 288483 0
Higher Education Commission - Indigenous PhD Scholarship
Country [1] 288483 0
Pakistan
Primary sponsor type
University
Name
Aga Khan University
Address
Stadium Road, Karachi 74800
Country
Pakistan
Secondary sponsor category [1] 287185 0
Individual
Name [1] 287185 0
Dr Anwar ul Hassan Gilani
Address [1] 287185 0
Aga Khan University, Stadium road, Karachi 74800
Country [1] 287185 0
Pakistan
Other collaborator category [1] 277747 0
Individual
Name [1] 277747 0
Dr. Fateh Ali Tipoo Sultan
Address [1] 277747 0
Aga Khan University, Stadium road, Karachi 74800
Country [1] 277747 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290346 0
Ethical Review Committee
Ethics committee address [1] 290346 0
Aga Khan University, Stadium Road Karachi 74800
Ethics committee country [1] 290346 0
Pakistan
Date submitted for ethics approval [1] 290346 0
01/06/2012
Approval date [1] 290346 0
04/01/2013
Ethics approval number [1] 290346 0
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 45218 0
Prof Dr. Anwar ul hassan Gilani
Address 45218 0
Aga Khan University, Stadium Road, Karachi 74800
Country 45218 0
Pakistan
Phone 45218 0
+92 21 34864571
Fax 45218 0
Email 45218 0
[email protected]
Contact person for public queries
Name 45219 0
Ms Humaira Nasir
Address 45219 0
Aga Khan University, Stadium Road, Karachi 74800
Country 45219 0
Pakistan
Phone 45219 0
+92 21 34864493
Fax 45219 0
Email 45219 0
[email protected]
Contact person for scientific queries
Name 45220 0
Ms Humaira nasir
Address 45220 0
Aga Khan University, Stadium Road, Karachi 74800
Country 45220 0
Pakistan
Phone 45220 0
+92 21 34864493
Fax 45220 0
Email 45220 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
EmbaseDietary Almonds Increase Serum HDL Cholesterol in Coronary Artery Disease Patients in a Randomized Controlled Trial1-3.2015https://dx.doi.org/10.3945/jn.114.207944
EmbaseAlmond supplementation reduces serum uric acid in coronary artery disease patients: A randomized controlled trial.2016https://dx.doi.org/10.1186/s12937-016-0195-4
N.B. These documents automatically identified may not have been verified by the study sponsor.