Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000322639
Ethics application status
Approved
Date submitted
13/03/2014
Date registered
26/03/2014
Date last updated
26/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of functional fiber on postprandial glycemia, energy intake, satiety, palatability and gastrointestinal wellbeing
Scientific title
The effects of functional fiber on postprandial glycemia, energy intake, satiety, palatability and gastrointestinal wellbeing in healthy adults: a randomized crossover trial
Secondary ID [1] 284263 0
Nil
Universal Trial Number (UTN)
U1111-1154-5191
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low dietary fibre intake 291384 0
Condition category
Condition code
Diet and Nutrition 291748 291748 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 291800 291800 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two fibre rich breads were baked. One bread contained 15 g/serve (two slices) of FibreMax (New Image International, Auckland, New Zealand). The other bread contained 15 g per serve of a prototype fiber extracted from a fruit product manufactured by Anagenix (Petone, New Zealand). Participants were randomized to one of the breads. The two slices of bread were consumed following a fasting period of at least 3 hours.
Participants were also randomized to order of consumption of their fibre-enriched bread or of a control bread without added fibre. The fibre bread and the control bread were consumed with a two week separation between clinic visits.
Intervention code [1] 288968 0
Lifestyle
Comparator / control treatment
Two control breads without added fibre were made. The two control breads had the same ingredients except that the control bread for the fruit product fiber bread was coloured with a food colouring to enable blinding of the investigators and participants.
Control group
Active

Outcomes
Primary outcome [1] 291684 0
Postprandial blood glucose concentrations using capillary blood obtained by fingerprick. Blood glucose concentrations will be measured using a Hemocue instrument checked each morning of use with a manufacturers control.
Timepoint [1] 291684 0
Within the two hours following consumption at 30, 45, 60, 90 and 120 min.
Primary outcome [2] 291685 0
Satiety assessed using paper-based visual analogue scales and food models
Timepoint [2] 291685 0
Within the three hours following consumption at thirty minute intervals
Primary outcome [3] 291686 0
Energy intake of a subsequent meal measured by providing an excess of pasta, weighing the leftovers and calculating the amount eaten by difference. The energy content of the pasta meal is known.
Timepoint [3] 291686 0
Three hours after eating
Secondary outcome [1] 307286 0
Gastrointestinal discomfort assessed with a series of questions relating to discomfort using a previously published questionnaire (Bovenschen et al. Dig Dis Sci 2000;51:1509-15) with some modification to make it specific to symptoms that may be experienced with high intakes of fibre
Timepoint [1] 307286 0
Within twenty four hours following consumption at 1, 2, 3, 8 and 24 hours
Secondary outcome [2] 307287 0
Palatability assessed with a visual analogue scale questionnaire based on that published by Flint et al (Int J Obes Relat Metab Disord 2000;24(1):38-48) with some modification including additional questions on texture and aftertaste.
Timepoint [2] 307287 0
Immediate response after eating

Eligibility
Key inclusion criteria
University students
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed with chronic or digestive diseases, food allergies, pregnancy, and taking medications or supplements likely to influence glucose metabolism or gastrointestinal wellbeing

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)
Participants were allocated to a fiber bread and to an order of consumption (treatment or control bread) using a computer generated random number list. The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed in that the breads had been colour coded such that the only the baker had knowledge of which bread corresponded to which colour code. The investigation team, including the person who allocated treatment, were unaware.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Two week washout between treatments. Testing of fiber and control bread was done on the same day of the week but two weeks apart.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multivariate general least square regression for random effects for blood glucose area under the curve; and satiety under the curve; and cumulative energy intake. Wilcoxon rank tests for immediate satiety response and return to hunger response. Pearson's chi-square test or Fisher’s exact test for comparing palatability.
A total of 31 participants per treatment group would be required to detect a 20% difference in glucose IAUC, with 80% power and a two sided a of 0.05. A 20% difference in postprandial glycaemia has clinical relevance.
A total of 34 participants per treatment group would be required to detect a 10% difference in energy intake, with 80% power and a two sided a of 0.05. A 10% difference in energy intake may have long term benefits of clinical significance.
35 participants sufficiently powered to detect a 10% difference (10mm on the visual analogue scale) at a power level of 0.8. A 10mm difference on the scale is considered sufficient to indicate a lower level of hunger.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2013
Actual
28/02/2013
Date of last participant enrolment
Anticipated
22/03/2013
Actual
22/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 5893 0
New Zealand
State/province [1] 5893 0
Otago

Funding & Sponsors
Funding source category [1] 288887 0
University
Name [1] 288887 0
University of Otago
Country [1] 288887 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 287583 0
None
Name [1] 287583 0
Address [1] 287583 0
Country [1] 287583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290715 0
University of Otago Human Ethics Committee
Ethics committee address [1] 290715 0
PO Box 56
Dunedin 9054
Ethics committee country [1] 290715 0
New Zealand
Date submitted for ethics approval [1] 290715 0
Approval date [1] 290715 0
03/02/2012
Ethics approval number [1] 290715 0

Summary
Brief summary
Fibre intakes in developed countries are generally below those recommended by relevant authorities. Given that many people consume fibre-depleted refined-grain products, adding functional fibre will help to increase fibre intakes. The objective of the study was to determine metabolic and sensory effects of adding fibre to bread.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46934 0
Dr Bernard Venn
Address 46934 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 46934 0
New Zealand
Phone 46934 0
+6434795068
Fax 46934 0
Email 46934 0
[email protected]
Contact person for public queries
Name 46935 0
Bernard Venn
Address 46935 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 46935 0
New Zealand
Phone 46935 0
+6434795068
Fax 46935 0
Email 46935 0
[email protected]
Contact person for scientific queries
Name 46936 0
Bernard Venn
Address 46936 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 46936 0
New Zealand
Phone 46936 0
+6434795068
Fax 46936 0
Email 46936 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

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