Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001352493
Ethics application status
Approved
Date submitted
27/09/2016
Date registered
29/09/2016
Date last updated
10/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Sugars Intake Measurement Study: A study to investigate the association between carbon and nitrogen stable isotope ratios as a biomarker of sugars intake in 120 healthy participants in New Zealand
Scientific title
Validation of carbon stable isotope ratios in red blood cells and hair as a biomarker of sugars intake in New Zealand
Secondary ID [1] 290218 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biomarker development of sugars intake. 300396 0
Condition category
Condition code
Diet and Nutrition 300259 300259 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will determine carbon and nitrogen stable isotope ratios in blood and hair samples as biomarkers of free sugars intakes. Blood and hair samples will be taken at baseline, and again 10 weeks later. During the 10 weeks, participants will complete a 7d diet record and two different food frequency questionnaire (FFQ) (a general FFQ and a sugar-specific FFQ).
Intervention code [1] 295987 0
Not applicable
Comparator / control treatment
Free sugars will be estimated by conventional dietary assessment methods including a general short food frequency questionnaire (FFQ), a sugars-specific FFQ and a 7d weighed diet record.
Control group
Active

Outcomes
Primary outcome [1] 299740 0
The association between carbon and nitrogen stable isotope ratios in red blood cells and self-reported dietary intakes of total sugars, free sugars, and added sugars.
Timepoint [1] 299740 0
10-week follow up
Primary outcome [2] 299741 0
The association between carbon and nitrogen stable isotope ratios in hair and self-reported dietary intakes of total sugars, free sugars, and added sugars.
Timepoint [2] 299741 0
10-wk follow up
Secondary outcome [1] 327974 0
The association between self-reported dietary intakes of total sugars, free sugars, and added sugars measured using a short FFQ, a sugars-specific FFQ, and a 7d diet record.
Timepoint [1] 327974 0
10-wk follow up

Eligibility
Key inclusion criteria
Healthy adults, aged 18-65 years, and a BMI < 27 kg/m2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Random sample
Timing
Both
Statistical methods / analysis
Power calculations indicate that 100 participants should be sufficient to detect a correlation of 0.3 between free sugars intakes, estimated from weighed diet records, and d13C. We will allow for a drop out rate of 20% giving a sample size of 120 subjects.

Seven recording days are required to capture habitual dietary intake of participants. Diet records will be analysed for major nutrients including free and total sugars using Kai-calculator software and the New Zealand Food Composition Database, and the average daily intake for energy, macronutrients, free and added sugars, and dietary fibre will be calculated.

Relative validity of the d13Cversus mean intakes of free sugars estimated weighed diet records (7 days total per person) will be assessed using Spearman correlation coefficients (SCC). Bland-Altman analyses will be performed to assess the strength of agreement between the d13C and 7d weighed diet record in measuring sugars intakes. Repeated measures two-way ANOVA will be used to assess the between-subject effect and to compare bulk d13C in various tissues at each monthly time point with adjustment for potential confounders including age, sex, body size, hair thickness, physical activity level and total energy intake.

Correlation coefficients (r) measured between nutritional biomarkers and reported dietary intake vary widely in research trials, with typical r values ranging from 0.03-0.70, with a mean of 0.39. These correlations may be interpreted as weak to modest, as they may underestimate the true validity of biomarkers due to the inherent inaccuracy of self-reported dietary intake measures. R values of 0.5-0.7 are typically considered acceptable as a precision in dietary validation studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2016
Actual
Date of last participant enrolment
Anticipated
1/03/2017
Actual
Date of last data collection
Anticipated
24/04/2017
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 8263 0
New Zealand
State/province [1] 8263 0
Otago

Funding & Sponsors
Funding source category [1] 294582 0
Government body
Name [1] 294582 0
Health Research Council of New Zealand
Country [1] 294582 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Office in Auckland:
Level 3, 110 Stanley St, Grafton, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 293459 0
None
Name [1] 293459 0
Address [1] 293459 0
Country [1] 293459 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296023 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 296023 0
The Academic Committees Office
PO Box 56
Dunedin 9016
New Zealand
Ethics committee country [1] 296023 0
New Zealand
Date submitted for ethics approval [1] 296023 0
10/10/2016
Approval date [1] 296023 0
09/11/2016
Ethics approval number [1] 296023 0

Summary
Brief summary
Restriction of free sugars is an almost universal recommendation despite a relatively high degree of inconsistency in the evidence base linking free sugars with health risks. Food industry continues to debate the relevance of sugar reduction strategies thus ongoing research to investigate the effects of sugar on population health is needed. Nutritional studies typically assess free sugars intakes using self-report methods which are subject to substantial misreporting thus observed diet-disease relationships are frequently obscured. Previous research in the U.S. has shown that carbon stable isotope ratios could be used as a objective measure of intakes of free sugars. The carbon stable isotope composition of a sweetener reflects the isotopic composition of the plant from which it originated. In NZ the majority of sweeteners are derived from sugar cane which has a distinctive d13C signature compared with other plant-derived foods and preliminary research has shown that d13C values in various tissues correlates with consumption of sugar-sweetened foods and drinks. For the validation current study, we will recruit 120 volunteers, measure the carbon stable isotopes in blood and hair samples as biomarkers of free sugars intakes and validate these markers against intakes of free sugars estimated by conventional dietary assessment methods including a general short food frequency questionnaire (FFQ), a sugars-specific FFQ and a 7d weighed diet record.
Trial website
None
Trial related presentations / publications
None
Public notes
Attachments [1] 1130 1130 0 0
/AnzctrAttachments/371554-Study Protocol.docx (Protocol)

Contacts
Principal investigator
Name 69274 0
Dr Lisa Te Morenga
Address 69274 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9016
Country 69274 0
New Zealand
Phone 69274 0
+6434793978
Fax 69274 0
Email 69274 0
[email protected]
Contact person for public queries
Name 69275 0
Dr Lisa Te Morenga
Address 69275 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9016
Country 69275 0
New Zealand
Phone 69275 0
+6434793978
Fax 69275 0
Email 69275 0
[email protected]
Contact person for scientific queries
Name 69276 0
Dr Lisa Te Morenga
Address 69276 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9016
Country 69276 0
New Zealand
Phone 69276 0
+6434793978
Fax 69276 0
Email 69276 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.