Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000215527
Ethics application status
Approved
Date submitted
17/02/2015
Date registered
5/03/2015
Date last updated
5/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of fructose intake on acute serum uric acid level and blood pressure
Scientific title
The effect of consuming foods and beverages containing fructose by healthy young adults on serum uric acid and blood pressure
Secondary ID [1] 286183 0
Nil
Universal Trial Number (UTN)
U1111-1167-2639
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperuricaemia 294211 0
Blood pressure 294212 0
Condition category
Condition code
Diet and Nutrition 294529 294529 0 0
Other diet and nutrition disorders
Cardiovascular 294617 294617 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an acute dietary intervention study in which healthy adults will be randomised to one of four groups. Group 1 - apples; Group 2 - apple juice; Group 3 a commercially available sucrose sweetened beverage (fizzy drink); Group 4 - a fructose drink and a glucose drink. Two serves of food will act as a crossover. For Groups 1 to 3, participants will consume either one serve (one apple; one glass of apple juice; or one can of fizzy drink) or two serves of the respective foods. One serve (one apple, a 250ml glass of juice or a 355ml can of fizzy) are commonly consumed items although a double serve (two apples, two glasses of juice or a 600ml bottle of fizzy) are within the realms of normal consumption for some people. The fructose content of one serve of each of those test foods will be within the range 15-20 g. The order of consumption will be randomised with a two week washout between tests. For Group 4, participants will consume a fructose beverage on one occasion and a glucose beverage on the other, again in randomised order. These are the control foods. The amount of fructose and glucose will be matched to that of the double food serve. At baseline and for one hour after consumption blood samples will be taken for uric acid analysis and blood pressure will be taken at baseline and 70 minutes.
Intervention code [1] 291195 0
Lifestyle
Intervention code [2] 291259 0
Prevention
Comparator / control treatment
A fructose solution will be made using pure fructose and carbonated water. It will be matched for fructose content to the double serve of test foods. This will control for effects of other nutrients in the test foods. A second control will be a glucose beverage. Glucose does not have uric acid raising potential and this will be used to control for time effects on uric acid during the experiment. Glucose also has a minimal effect on blood pressure and heart rate, so this will be used to control for time effects when assessing the fructose test foods.
Control group
Active

Outcomes
Primary outcome [1] 294306 0
Serum uric acid concentrations using capillary blood obtained by a finger prick
Timepoint [1] 294306 0
Baseline, and 30 and 60 minutes following ingestion of the test food
Primary outcome [2] 294307 0
Blood pressure will be assessed as the mean of three determinations using an automatic sphygmomanometer
Timepoint [2] 294307 0
Baseline and seventy minutes following ingestion of the test food
Secondary outcome [1] 313000 0
Heart rate will be assessed as the mean of three determinations using an automatic sphygmomanometer. The Omron sphygmomanometer displays pulse rate (beats per minute) after each blood pressure determination.
Timepoint [1] 313000 0
Baseline and 70 minutes following ingestion of the test food
Secondary outcome [2] 313001 0
Blood glucose will be assessed with a Hemocue blood glucose meter using capiliary blood obtained by finger-prick
Timepoint [2] 313001 0
Baseline and 30 and 60 minutes following ingestion of the test food
Secondary outcome [3] 313002 0
Satiety will be assessed using 100mm visual analogue scales
Timepoint [3] 313002 0
Baseline and 30 and 60 minutes following ingestion of the test food

Eligibility
Key inclusion criteria
University students
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People diagnosed with chronic disease including diabetes mellitus, cardiovascular disease, cancer, and diseases of the digestive system; and women who are pregnant.

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 allocated to a test food and to an order of
consumption (single or double the amount of food) using a computer generated random number list. The person who will determine if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated. Allocation will be concealed from the research personnel conducting the study up to the time of the start of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation to balance males and females into each of the four intervention groups. Simple randomization for order of treatment. All randomization will be done using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
There will be four treatment groups in parallel (apples; fruit juice; sugary beverage; control). Within each of the four intervention groups, each participant will consume in a crossover design (with a two week washout), either a single serve or a double serve of the foods.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A total of 20 participants per group would be required to detect a difference of 50 micromol/L in plasma uric acid with 80% power and a two-sided significance level of 0.05. This was determined using a mean of 340 micromol/L and a standard deviation of 80 micromol/L. A two-sided paired t-test will be used to compare baseline and final uric acid levels for each test. Twenty participants per group will be ample to detect a change in blood pressure of 3 mmHg over the course of the experiment. ANCOVA will be used to test for differences in the primary outcomes among the groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/02/2015
Actual
27/02/2015
Date of last participant enrolment
Anticipated
27/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 6663 0
New Zealand
State/province [1] 6663 0
Otago

Funding & Sponsors
Funding source category [1] 290753 0
University
Name [1] 290753 0
University of Otago
Country [1] 290753 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 289439 0
None
Name [1] 289439 0
Address [1] 289439 0
Country [1] 289439 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292385 0
University of Otago Human Ethics Committee
Ethics committee address [1] 292385 0
Ethics committee country [1] 292385 0
New Zealand
Date submitted for ethics approval [1] 292385 0
Approval date [1] 292385 0
25/11/2014
Ethics approval number [1] 292385 0

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

Contacts
Principal investigator
Name 54954 0
Dr Bernard Venn
Address 54954 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 54954 0
New Zealand
Phone 54954 0
+6434795068
Fax 54954 0
Email 54954 0
[email protected]
Contact person for public queries
Name 54955 0
Bernard Venn
Address 54955 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 54955 0
New Zealand
Phone 54955 0
+6434795068
Fax 54955 0
Email 54955 0
[email protected]
Contact person for scientific queries
Name 54956 0
Bernard Venn
Address 54956 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country 54956 0
New Zealand
Phone 54956 0
+6434795068
Fax 54956 0
Email 54956 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
EmbaseThe effects of apples and apple juice on acute plasma uric acid concentration: A randomized controlled trial.2018https://dx.doi.org/10.1093/ajcn/nqx059
N.B. These documents automatically identified may not have been verified by the study sponsor.