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Trial registered on ANZCTR


Registration number
ACTRN12614000431628
Ethics application status
Approved
Date submitted
14/04/2014
Date registered
29/04/2014
Date last updated
29/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary fructose consumption and cardio-metabolic health
Scientific title
Dietary fructose increases blood lipids and inflammation and reduces insulin response and satiety hormones in healthy volunteers.
Secondary ID [1] 284420 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardio-metabolic Health 291621 0
Metabolic-Syndrome 291622 0
Condition category
Condition code
Diet and Nutrition 291998 291998 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 291999 291999 0 0
Metabolic disorders
Cardiovascular 292000 292000 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A dietary intervention acute trial will be conducted in healthy subjects, in randomized controlled cross-over design. Acute trial will involve dietary intervention with a single dose of sugar (fructose/glucose/sucrose) sweetened drink followed by collection of blood samples at 0, 30, 60, and 120 minutes following consumption of a) lemon-flavoured drink containing 50g of fructose, b) lemon-flavoured drink containing 50g of glucose and c) lemon flavoured drink containing 50g of sucrose. After a 1 week period of wash out the experiment will be repeated swapping groups. Subjects will be asked to fill a medical and a physical activity questionnaire and will have their anthropometric measurements taken. In addition, subjects will complete a 24 hour food record.
Intervention code [1] 289170 0
Lifestyle
Intervention code [2] 289171 0
Prevention
Comparator / control treatment
Sucrose
Control group
Active

Outcomes
Primary outcome [1] 291891 0
To examine the acute effects of fructose consumption on:
Blood Lipids
Timepoint [1] 291891 0
At base line, 30, 60 and 120 minutes
Primary outcome [2] 291892 0
To examine the acute effects of fructose consumption on:
Satiety Hormones

This outcome will be analysed by blood serum assays
Timepoint [2] 291892 0
At baseline, 30, 60 and 120 minutes
Primary outcome [3] 291893 0
To examine the acute effects of fructose consumption on:
Inflammatory Bio-markers (hs-CRP)

This outcome will be analysed by blood serum assays
Timepoint [3] 291893 0
At baseline, 30, 60 and 120 minutes
Secondary outcome [1] 307749 0
To examine the acute effects of fructose consumption on:
Insulin Resistance

This outcome will be analysed by blood serum assays
Timepoint [1] 307749 0
At baseline, 30, 60 and 120 minutes

Eligibility
Key inclusion criteria
Healthy male or female.
Are aged above 18 years at initial assessment
Minimum age
18 Years
Maximum age
65 Years
Gender
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 fructose/sugar restricted diet
Currently on weight loss program
Have a body mass index (BMI) greater than 30
Diagnosed with any gastrointestinal disorder
Diabetes
Pregnancy or lactation
Vegan diet
Undergone any surgical procedure for obesity

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)
A randomised controlled, dietary intervention trial, in a cross-over design. Participants will be recruited by advertisement in newspaper and radio interviews as well as from the HMRI register of volunteers. Allocation is not concealed.
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
Crossover
Other design features
NIL
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7982 0
2308 - Newcastle University
Recruitment postcode(s) [2] 7983 0
2308 - Callaghan

Funding & Sponsors
Funding source category [1] 289069 0
Other
Name [1] 289069 0
Hunter Medical Research Institute (HMRI)
Address [1] 289069 0
1/Kookaburra Circuit,
New Lambton Heights,
NSW 2305
Country [1] 289069 0
Australia
Primary sponsor type
University
Name
The UNiversity of Newcastle
Address
University Drive
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 287732 0
Other
Name [1] 287732 0
Hunter Medical Research Institute (HMRI)
Address [1] 287732 0
1/Kookaburra Circuit,
New Lambton Heights,
NSW 2305
Country [1] 287732 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290863 0
The University of Newcastle Human Ethics Committee
Ethics committee address [1] 290863 0
Research Office, The Chancellery, The University of Newcastle, University Drive, Callaghan, NSW 2308
Ethics committee country [1] 290863 0
Date submitted for ethics approval [1] 290863 0
22/05/2012
Approval date [1] 290863 0
06/08/2012
Ethics approval number [1] 290863 0
H-2011-0336

Summary
Brief summary
There is evidence in the published literature that consumption of a high fructose diet is detrimental to cardio-metabolic health. The purpose of this research is to determine the effect of dietary fructose consumption on plasma lipids, satiety hormones, insulin resistance and inflammation. If our hypothesis is validated, dietary strategies can be designed to reduce body weight and associated risk for the development of diabetes and cardiovascular disease
Trial website
Trial related presentations / publications
Faizan Jameel Nov 2013
Presented at Australasian Section of AOCS
06-08 November 2013, Newcastle, Australia

Faizan Jameel Dec 2013
Presented at Annual Scientific Meeting of The Nutrition Society of Australia, in conjunction with The Nutrition Society Of New Zealand,
04-06 December 2013, Brisbane, Australia
Public notes

Contacts
Principal investigator
Name 47646 0
Prof Manohar Garg
Address 47646 0
MS305C, School of Biomedical Sciences and Pharmacy, The University of Newcastle University Drive, Callaghan, NSW 2308

Country 47646 0
Australia
Phone 47646 0
+ 61 2 4921 5647
Fax 47646 0
+ 61 2 4921 2028
Email 47646 0
Manohar.Garg@newcastle.edu.au
Contact person for public queries
Name 47647 0
Mr Faizan Jameel
Address 47647 0
MS305B, School of Biomedical Sciences and Pharmacy, The University of Newcastle University Drive, Callaghan, NSW 2308
Country 47647 0
Australia
Phone 47647 0
+ 61 2 4921 5638
Fax 47647 0
Email 47647 0
Faizan.Jameel@uon.edu.au
Contact person for scientific queries
Name 47648 0
Prof Manohar Garg
Address 47648 0
MS305C, School of Biomedical Sciences and Pharmacy, The University of Newcastle University Drive, Callaghan, NSW 2308
Country 47648 0
Australia
Phone 47648 0
+ 61 2 4921 5647
Fax 47648 0
+ 61 2 4921 5647
Email 47648 0
Manohar.Garg@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary