Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000291482
Ethics application status
Approved
Date submitted
2/03/2016
Date registered
7/03/2016
Date last updated
7/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating how the physical form of food affects the absorption of contained starch and carbohydrate by the gut
Scientific title
A method for assessing real time rates of dissolution and absorption of carbohydrate and other food matrices in healthy female subjects
Secondary ID [1] 288668 0
Nil/None
Universal Trial Number (UTN)
U1111-1180-2163
Trial acronym
NUI trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The absorption of carbohydrate from different food matrices 297860 0
Condition category
Condition code
Oral and Gastrointestinal 298035 298035 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The uptake of 10 g lactulose and 5 g mannitol incorporated into (a) 50 g of uncooked extruded pasta pellets (mean diameter: 3.18 millmetre ) made of maize flour (b) 50 g of uncooked hydrated (1:2 w/w in water) powdered pasta pellets and (c) a control consisting of 50 ml of the two probe sugars dissolved in water. All of these interventions were mixed with 150 g of 'fruit sauce' containing 0.1 % Guar gum (Grindsted (Registered Trademark), DaniscoPvt Ltd, Australia), 0.3 % Xanthan (80 Mesh, ISXANT8.1, IngredientStop) and 0.02 % vanilla flavouring (Batch 181110, Zymus) and a standard volume of water. Lactulose and mannitol was determined by measuring their excretion in urine by high performace liquid chromatography (HPLC).
These foods each were fed to 22 healthy female participants (screened by questionnaire) in random sequence at weekly intervals. The subjects were asked to empty their bladder every half-hour over a six hour period. Venous blood was collected every half-hour over four hours and thereafter at five and six hours for plasma blood glucose and plasma insulin determination. Comparisons of the temporal pattern of absorption of each of the two probe sugars sugar and the blood glucose values for six hours after consumption of each food with that of the control will provide an indication of the effect of processing on the rates of absorption of nutrients from the gut lumen.
Intervention code [1] 294084 0
Treatment: Other
Comparator / control treatment
The temporal patterns of absorption of lactulose and mannitol will be determined after consumption of either of the following foods that contain 10 g lactulose and 5 g mannitol incorporated into them (50 g of uncooked extruded pasta pellets < 1 m made of maize flour, (b) 50 g of uncooked hydrated (1:2 w/w in water) powdered pasta pellets and (c) a control consisting of 50 ml of the two probe sugars dissolved in water.
Control group
Active

Outcomes
Primary outcome [1] 297550 0
Quantification of nutrient uptake index (NUI) which represents the speed at which simple sugars are liberated from the food matrix into the lumen of the small intestine and absorbed by the mucosa.
Timepoint [1] 297550 0
Urine samples were collected from subjects every half-hour over a six hour period.
Secondary outcome [1] 321386 0
A composite secondary outcome was to compare the rates of appearance of glucose and insulin in the systemic circulation with the rate of absorption of mannitol and lactulose to better quantify the differences in kinetics of active absorption from those of passive absorption
Timepoint [1] 321386 0
Along with urine samples, venous blood was collected from an indwelling cannula every half-hour over four hours and then at five and six hours respectively. The temporal pattern of absorption of each of the two probe sugars and the plasma blood glucose and plasma insulin values for six hours after consumption of each food and after the control will be compared.

Eligibility
Key inclusion criteria
Female volunteers between the age of 20 and 40 years were screened by questionnaire for general medical health, gut health, ongoing consumption of medication, dietary supplements, dietary peculiarities and smoking. Inclusion criteria is as follows: (1) Participants were non-smokers with no history of gastrointestinal diseases including recent gut infection evidenced by a recent history of abdominal pain, nausea, vomiting, diarrhea, passage of blood and mucus in stools. (2) Participants were not taking any ongoing prescription or OTC medication or multivitamins except for contraceptive pills. (3) The number of Standard alcohol drinks consumed per week were calculated from results of alcohol consumption in the questionnaire to ensure that participants did not exceed a moderate alcohol intake. (4) Participants did not have high levels of endogenously produced mannitol or lactulose in the urine.
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants were screened by a Health Questionnaire (attached) to determine participation in the study. Volunteers who were excluded are: Those that had high levels of endogenously produced mannitol or lactulose in the urine, smokers, exceeded the intake of one standard alcohol drink per day, had a history of gastrointestinal diseases including recent gut infection evidenced by a recent history of abdominal pain, nausea, vomiting, diarrhea, passage of blood and mucus in stools, had a history of or current urinary tract infections, vaginal conditions that cause discharge, took ongoing prescription medication, antibiotics, OTC medication or multivitamins, took prebiotic and probiotic supplements such as lactulose.

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)
Allocation is not concealed. All subjects were screened by health questionnaire to exclude those with a personal or strong family history of chronic gastrointestinal (GI) disorders or recent abdominal pain, nausea, vomiting, diarrhea, passage of blood and mucus in stools. Similarly smokers, those with an intake of alcohol in excess of one standard drink per day and those taking regular prescription or over the counter medications (OTC), consuming vitamins, prebiotics or probiotic supplements such as lactulose were excluded. Subjects were also asked to refrain from taking any NSAIDs for at least a week prior to the test, to refrain from consuming alcohol for three days prior to the test and to avoid exercise on the day before and the morning of the test. All subjects were reviewed by a clinician to validate their medical history and their responses to the questionnaire before they were admitted to the study. Each participant received each of the three treatments in a randomized sequence at weekly intervals. The order of the treatments was randomized based on a computer generated sequence and was blinded to the subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer software (www.randomization.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No data was available regarding absorption of mannitol or lactulose from pasta pellets or powder. Hence meaningful test of statistical power were not available and the number of subjects was chosen based on previous studies conducted by us using the lactulose mannitol solution that have used a similar sample size and obtained statistically significant results. Differences between interventions was assessed by using parametric multivariate analysis of variance

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
19/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 7636 0
New Zealand
State/province [1] 7636 0
Palmerston North

Funding & Sponsors
Funding source category [1] 293025 0
Government body
Name [1] 293025 0
Ministry of Business and Innovation, Pre Seed Accelerator Funding Contract Number MAUX1409
Country [1] 293025 0
New Zealand
Funding source category [2] 293036 0
University
Name [2] 293036 0
Massey Ventures Limited, Massey University
Country [2] 293036 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Tiritea Campus,
Tennent Drive
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 291811 0
None
Name [1] 291811 0
Address [1] 291811 0
Country [1] 291811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294546 0
Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 294546 0
Ethics committee country [1] 294546 0
New Zealand
Date submitted for ethics approval [1] 294546 0
01/05/2015
Approval date [1] 294546 0
25/05/2015
Ethics approval number [1] 294546 0
15/31

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 793 793 0 0
/AnzctrAttachments/370248-Information sheet - NUI .pdf
Attachments [2] 794 794 0 0
/AnzctrAttachments/370248-SOP urine collection- NUI.pdf
Attachments [3] 795 795 0 0
/AnzctrAttachments/370248-HSQ - NUI .pdf

Contacts
Principal investigator
Name 64050 0
Dr Roger Graham Lentle
Address 64050 0
Professor of Digestive Biomechanics, Massey University Massey Institute of Food Science and Technology, School of Food and Nutrition College of Health Private Bag 11222 Palmerston North 4442
Country 64050 0
New Zealand
Phone 64050 0
+64 (0) 6 350 81402
Fax 64050 0
+64 (0)6 350 5657
Email 64050 0
[email protected]
Contact person for public queries
Name 64051 0
Ivana Roosevelt Sequeira
Address 64051 0
Massey University Massey Institute of Food Science and Technology, School of Food and Nutrition College of Health Private Bag 11222 Palmerston North 4442
Country 64051 0
New Zealand
Phone 64051 0
+64 (0)6 350 83367
Fax 64051 0
+64 (0)6 350 5657
Email 64051 0
[email protected]
Contact person for scientific queries
Name 64052 0
Roger Graham Lentle
Address 64052 0
Professor of Digestive Biomechanics, Massey University Massey Institute of Food Science and Technology, School of Food and Nutrition College of Health Private Bag 11222 Palmerston North 4442
Country 64052 0
New Zealand
Phone 64052 0
+64 (0) 6 350 81402
Fax 64052 0
+64 (0)6 350 5657
Email 64052 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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