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Trial registered on ANZCTR


Registration number
ACTRN12612000856819
Ethics application status
Approved
Date submitted
13/08/2012
Date registered
14/08/2012
Date last updated
14/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Postprandial effects of almond lipids on cardiovascular risk factors
Scientific title
Postprandial effects of almond lipids on cardiovascular risk factors in healthy male and female subjects
Secondary ID [1] 281020 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial effects of almond lipids on cardiovascular risk factors 287155 0
Condition category
Condition code
Cardiovascular 287474 287474 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled dietary intervention trial, involving healthy (BMI <30kg/m2) human adults. Subjects will receive in random order the following treatments with a washout period of at least one week between the treatments:

1. raw almonds (approx. 60g)
2. almond extract or milk (apprrox. 300mL)
3. almond oil emulsion (approx. 300mL)
4. almond oil (approx. 30g)

At each of the 4 study visits, subjects will donate a blood sample at 0, 1.5, 2.0, 2.5, 3.0, 3.5, 5.0 and 6.0 hours for assessment
Intervention code [1] 285479 0
Prevention
Comparator / control treatment
Active (cross-over study). There is no control group as each participant's fasting blood sample will act as the control and compared to blood samples collected following each of the treatments. This will be for each of the 4 interventions.
Control group
Active

Outcomes
Primary outcome [1] 287742 0
The aim of this project is to examine the effects of matrix in which almond lipids are complexed on postprandial lipid levels, inflammation markers, and satiety hormones.
The primary outcome measured are the changes in lipids
Timepoint [1] 287742 0
At each of the 4 intervention sessions, blood will be collected and these biomarkers measured at baseline, 1.5, 2.0, 2.5, 3.0, 3.5, 5.0 and 6.0 hours after treatment.
Secondary outcome [1] 298759 0
The secondary outcome measured are the changes in inflammatory biomarkers (Human C reactive protein
Tumour necrosis factor-aplha, Interleukin-6)
Timepoint [1] 298759 0
At each of the 4 intervention sessions, blood will be collected and these biomarkers measured at baseline, 1.5, 2.0, 2.5, 3.0, 3.5, 5.0 and 6.0 hours after treatment.

Eligibility
Key inclusion criteria
Healthy male or female.
Are aged between 18-65 years at initial assessment.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently on cholesterol lowering drugs
Currently on non-steroidal anti-inflammatory drugs
Currently on weight loss program
Have a body mass index (BMI) higher than 30
Diagnosed with any gastrointestinal disorder
Diabetes
Pregnancy or lactation
Allergic to nuts, particularly almonds

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from the community using media advertising. Potential participants will contact the study investigator and be given a copy of the Information Statement for the study to consider their participation and consent. Participants will be screened for eligility by the researcher either in person or over the phone using the inclusion and exclusion criteria as mentioned previously. Elibigle participants would then be allocated a number using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned to a participant identifcation number (PIN) once enrolled. The numbers will have already been assigned to a treatment group which determines the treatment allocation of the participant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285807 0
Self funded/Unfunded
Name [1] 285807 0
Nutraceuticals Research
Country [1] 285807 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Riddet Institute
Address
Cnr University Avenue and Orchard Road,
Massey University
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 284631 0
University
Name [1] 284631 0
University of Newcastle
Address [1] 284631 0
University of Newcastle,
University Drive, Callaghan
NSW 2308
Country [1] 284631 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287822 0
Human Research Ethics Committee of The University of Newcastle
Ethics committee address [1] 287822 0
The Chancellory Building
The University of Newcastle,
University Drive
Callaghan, NSW 2308
Ethics committee country [1] 287822 0
Australia
Date submitted for ethics approval [1] 287822 0
01/02/2012
Approval date [1] 287822 0
29/05/2012
Ethics approval number [1] 287822 0
H-2012-0119

Summary
Brief summary
Although the association of nutritional composition of foods with health parameters is well established, the physical structure can influence the digestion, absorption and consequently may affect caridovascular health indices namely, circulating lipid levels, inflammatory mediators and satiety hormones. Interactions between the nutrients due to food processing can change, influencing the accessibility of the digestive enzymes for hydrolysis. In this context, although type of dietary fat consumed has been shown to modulate blood cholesterol levels, the matrix of the food may influence its cholesterol raising/lowering potential. Accordingly, the rate of absorption of fat from a meal containing whole almonds has been shown to be much slower compared to almond oil.

The aim of this project is to examine the effects of matrix in which almond lipids are complexed on postprandial lipid levels, inflammation markers, and satiety hormones. This will be achieved by determining the effects of feeding four different almond preparations, i.e. lipids trapped within the cell walls (raw almonds), oleosin-stabilized lipid emulsion (almond extract or milk), casein-stabilized lipid emulsion (almond oil emulsion) and lipids as free oil (almond oil).

We hypothesise that the rate of absorption of fat from almonds, almond oil and emulsified almond oil will be different and in turn may influence cardiovascular disease risk factors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34572 0
Address 34572 0
Country 34572 0
Phone 34572 0
Fax 34572 0
Email 34572 0
Contact person for public queries
Name 17819 0
Manohar Garg
Address 17819 0
305C Medical Sciences Building
The University of Newcastle
Callaghan, NSW 2308
Country 17819 0
Australia
Phone 17819 0
+ 61 2 49215647
Fax 17819 0
+ 612 49212028
Email 17819 0
[email protected]
Contact person for scientific queries
Name 8747 0
Manohar Garg
Address 8747 0
305C Medical Sciences Building
The University of Newcastle
Callaghan, NSW 2308
Country 8747 0
Australia
Phone 8747 0
+ 61 2 49215647
Fax 8747 0
+ 612 49212028
Email 8747 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
No additional documents have been identified.