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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]

Nil

Universal Trial Number (UTN)

U1111-1167-2639

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hyperuricaemia

Blood pressure

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Cardiovascular

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]

Lifestyle

Intervention code [2]

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]

Serum uric acid concentrations using capillary blood obtained by a finger prick

Timepoint [1]

Baseline, and 30 and 60 minutes following ingestion of the test food

Primary outcome [2]

Blood pressure will be assessed as the mean of three determinations using an automatic sphygmomanometer

Timepoint [2]

Baseline and seventy minutes following ingestion of the test food

Secondary outcome [1]

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]

Baseline and 70 minutes following ingestion of the test food

Secondary outcome [2]

Blood glucose will be assessed with a Hemocue blood glucose meter using capiliary blood obtained by finger-prick

Timepoint [2]

Baseline and 30 and 60 minutes following ingestion of the test food

Secondary outcome [3]

Satiety will be assessed using 100mm visual analogue scales

Timepoint [3]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

PO Box 56
Dunedin 9054

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO Box 56
Dunedin 9054

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee

Ethics committee address [1]

PO Box 56
Dunedin 9054

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

25/11/2014

Ethics approval number [1]

Summary

Brief summary

Gout, hyperuricemia and hypertension are prevalent in New Zealand. In animal experiments and human studies involving large intakes of free fructose, fructose has been linked to increasing serum uric acid concentrations and elevated blood pressure. More studies are required to test whether uric acid and blood pressure are raised acutely when more realistic fructose intakes contained in real foods are consumed. The objective of this study is to test whether consuming fructose from commonly consumed foods in realistic serving sizes has an affect on acute post-ingestion serum uric acid concentration and blood pressure.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bernard Venn

Address

University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+6434795068

Fax

bernard.venn@otago.ac.nz

Contact person for public queries

Name

Bernard Venn

Address

University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+6434795068

Fax

bernard.venn@otago.ac.nz

Contact person for scientific queries

Name

Bernard Venn

Address

University of Otago
Department of Human Nutrition
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+6434795068

Fax

bernard.venn@otago.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	The effects of apples and apple juice on acute plasma uric acid concentration: A randomized controlled trial.	2018	https://dx.doi.org/10.1093/ajcn/nqx059

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically