Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000312448
Ethics application status
Approved
Date submitted
29/01/2016
Date registered
9/03/2016
Date last updated
25/03/2021
Date data sharing statement initially provided
25/03/2021
Date results provided
25/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of quinoa on blood lipids and circulating adiponectin in humans.
Scientific title
Effect of quinoa on blood lipids, circulating adiponectin, blood markers and physical activity in overweight/obese humans. Dose response trial compared to control group
Secondary ID [1] 288448 0
Nil
Universal Trial Number (UTN)
U1111-1175-4070
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 297474 0
Hyperlipidaemia 297475 0
Condition category
Condition code
Diet and Nutrition 297660 297660 0 0
Obesity
Metabolic and Endocrine 297661 297661 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly allocated into one of the four different treatment groups receiving either 0, 25, 50, or 100 grams of quinoa per day during 12 weeks intervention period. Participants are advised to consume the white quinoa seeds supplied at their convenience filling a quinoa calendar provided every day when quinoa is consumed, this calendar is returned in the following appointment.
Intervention code [1] 293775 0
Treatment: Other
Intervention code [2] 293779 0
Lifestyle
Comparator / control treatment
Control treatment receive 0 gr of quinoa.
Control group
Dose comparison

Outcomes
Primary outcome [1] 297195 0
Blood Sample is taken into an SST tube (Serum Separating Tube) to analyse Circulating adiponectin
Timepoint [1] 297195 0
Time point: Baseline which includes 1hr and 2hrs after quinoa breakfast consumption and 6 and 12 weeks follow the first appointment
Primary outcome [2] 297205 0
Blood sample is taken into an SST tube (Serum Separating Tube) to analyse Lipid profile
Timepoint [2] 297205 0
Baseline which includes 1 hr and 2 hrs after consumption of quinoa breakfast, 6 and 12 weeks intervention.
Secondary outcome [1] 320305 0
Body composition measured using a DEXA scan
Timepoint [1] 320305 0
Baseline, 6 and 12 weeks
Secondary outcome [2] 320306 0
Physical Activity measure an ActiGraph Activity Monitor
Timepoint [2] 320306 0
Baseline and 12 weeks

Eligibility
Key inclusion criteria
Participants are checked against eligibility criteria before inclusion in the study. Inclusion criteria includes: BMI greater than 25, be able to communicate in English, age between 18 and 65 years old.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes BMI lower than 25, diagnosis diabetes or heart disease, pregnancy and also those taking medication for blood cholesterol management.

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)
Recruited participants are checked against the inclusion and exclusion criteria prior the enrollment for the study. Participants are randomly allocated into one of the four treatment groups by computer generated random number conducted by holder of the allocation schedule (Not the trial coordinator).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is done by block randomisation generating a list of random number in a computer program stratifying by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed by applying appropriate statistical tests using SPSS Inc. software Version 21, p <0.05 will be considered statistically significant. Of note, this is a pilot/ study of 100 participants, comprising 25 in each of the four treatment groups. A drop out rate of 20% or less is expected, this will equate to a minimum expected completion of 20 participants per treatment group which is considered suitable for the exploratory study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/02/2015
Date of last participant enrolment
Anticipated
15/09/2016
Actual
31/05/2016
Date of last data collection
Anticipated
19/08/2016
Actual
31/08/2016
Sample size
Target
100
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12667 0
3083 - Bundoora
Recruitment postcode(s) [2] 12668 0
3086 - La Trobe University
Recruitment postcode(s) [3] 12669 0
3088 - Greensborough
Recruitment postcode(s) [4] 12670 0
3087 - Watsonia
Recruitment postcode(s) [5] 12671 0
3089 - Diamond Creek
Recruitment postcode(s) [6] 12672 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 292792 0
University
Name [1] 292792 0
La Trobe University
Country [1] 292792 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Dr/Plenty Rd, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 291530 0
None
Name [1] 291530 0
Address [1] 291530 0
Country [1] 291530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294284 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 294284 0
Ethics committee country [1] 294284 0
Australia
Date submitted for ethics approval [1] 294284 0
08/08/2014
Approval date [1] 294284 0
29/10/2014
Ethics approval number [1] 294284 0
HEC 14 - 065

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

Contacts
Principal investigator
Name 63186 0
Dr Markandeya Jois
Address 63186 0
La Trobe University, Bundoora VIC 3086
Country 63186 0
Australia
Phone 63186 0
+61 3 9479 2172
Fax 63186 0
Email 63186 0
[email protected]
Contact person for public queries
Name 63187 0
Diana Navarro - Perez
Address 63187 0
La Trobe University, Bundoora VIC 3086
Country 63187 0
Australia
Phone 63187 0
+61 3 9479 6039
Fax 63187 0
Email 63187 0
[email protected]
Contact person for scientific queries
Name 63188 0
Markandeya Jois
Address 63188 0
La Trobe University, Bundoora VIC 3086
Country 63188 0
Australia
Phone 63188 0
+61 3 9479 2172
Fax 63188 0
Email 63188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.