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Trial registered on ANZCTR


Registration number
ACTRN12614001141639
Ethics application status
Approved
Date submitted
20/10/2014
Date registered
28/10/2014
Date last updated
28/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postprandial Glucose and Insulin Effects of a Filtered Sugarcane Molasses Concentrate in Healthy Subjects after a Standardised Breakfast Meal
Scientific title
In healthy subjects, will a filtered sugarcane molasses concentrate lower postprandial glucose or insulin responses following a standardised breakfast meal compared to placebo?
Secondary ID [1] 285511 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemic control 293308 0
Insulinaemic control 293309 0
Condition category
Condition code
Diet and Nutrition 293583 293583 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 293584 293584 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acute administration of a phytochemical- and mineral-rich filtered sugarcane molasses concentrate (FMC) given as a supplement consumed immediately prior to a standard breakfast meal. All 38 subjects tested Meals 1 to 3, a subset of 15 subjects also tested Meals 4 and 5. The product was given to all subjects in two different doses, 8 g and 22 g, and a sugar-containing, dark-coloured placebo syrup was used as a control. The 15 subjects who were enrolled in the trial extension also subsequently ingested FMC doses of 40 g and 60 g.

Each subject consumed the first three meals, in random order, each on a separate occasion with at least 1 day washout in between. The test meals consisted of:
1. Test Meal 1: 30 g placebo syrup consumed with 100 g of white bread, 12 g butter, 65 g scrambled eggs and 170 g orange & mango juice.
2. Test Meal 2: 8 g FMC + 22 g water consumed with 100 g white bread, 12 g butter, 65 g scrambled eggs and 170 g orange & mango juice.
3. Test Meal 3: 22 g FMC + 8 g water consumed with 100 g white bread, 12 g butter, 65 g scrambled eggs and 170 g orange & mango juice.
The extra meals tested by 15 subjects, in random order, during the trial extension consisted of:
1. Test Meal 4: 40 g FMC syrup + 45 g water consumed with 100 g white bread, 12 g butter, 65 g scrambled eggs and 170 g orange & mango juice.
2. Test Meal 5: 60 g FMC + 25 g water consumed with 100 g white bread, 12 g butter, 65 g scrambled eggs and 170 g orange & mango juice.

Placebo and FMC syrups were visually similar dark-coloured liquids but differed in smell and taste. Subjects were blinded as to which syrups were investigational products and which placebo.

The study used a crossover design such that every subject consumed each Test Meal on one occasion only in random order, completing a total of three (or five) test sessions. Each subject completed his or her test sessions on separate weekday mornings at a similar time of day, as close as possible to the time at which the subject normally ate breakfast.
Pre-meal supplement and meal were consumed within twelve minutes, subjects were required to remain seated during their test sessions and only minimal movement was allowed (visiting the rest rooms or walking a couple of meters to the blood sampling area). During each test session, the subjects were monitored by research staff to ensure they complied with the test conditions.
Intervention code [1] 290452 0
Prevention
Intervention code [2] 290453 0
Treatment: Other
Comparator / control treatment
Placebo was a sugar-containing, dark-coloured syrup taken before the standardised breakfast meal.
The placebo/test meal was as follows: 30 g placebo syrup consumed with 100 g of white bread, 12 g butter, 65 g scrambled eggs and 170 g orange & mango juice.
Placebo and FMC syrups were visually similar dark-coloured liquids but differed in smell and taste. Subjects were blinded as to which syrups were investigational products and which placebo.
Each subject completed his or her test sessions on separate weekday mornings at a similar time of day, as close as possible to the time at which the subject normally ate breakfast.
Pre-meal supplement and meal were consumed within twelve minutes, subjects were required to remain seated during their test sessions and only minimal movement was allowed (visiting the rest rooms or walking a couple of meters to the blood sampling area). During each test session, the subjects were monitored by research staff to ensure they complied with the test conditions.
Control group
Placebo

Outcomes
Primary outcome [1] 293394 0
Difference in postprandial glucose responses, assayed by collection of blood samples (via finger prick) and analysis with a glucose hexokinase enzymatic assay (Roche Diagnostic Systems, Sydney, Australia).
Timepoint [1] 293394 0
0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
Primary outcome [2] 293395 0
Difference in postprandial insulin responses, assayed by collection of blood samples (via finger prick) and analysis using a solid-phase antibody-coated tube radioimmunoassay kit (Coat-a-Count (registered trademark) Insulin RIA kit, Diagnostic Products Corporation, Los Angeles, CA, USA).
Timepoint [2] 293395 0
0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min
Secondary outcome [1] 310934 0
Nil
Timepoint [1] 310934 0
None

Eligibility
Key inclusion criteria
Healthy, normal BMI (18-25 kg/m2) subjects
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Over- or underweight, were dieting, had impaired glucose tolerance, were suffering from any illness or food allergy, or were regularly taking prescription medication other than standard contraceptive medication.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
The sample size of 38 subjects was selected to allow detection of an effect size of 0.35 in postprandial glucose iAUC (22 g Benecarb vs. placebo) with 80% power and 2-sided alpha of 0.05, allowing for 10% attrition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290108 0
Commercial sector/Industry
Name [1] 290108 0
Horizon Science
Address [1] 290108 0
6/84-90 Lakewood Blvd
Braeside VIC 3195
Country [1] 290108 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Horizon Science
Address
6/84-90 Lakewood Blvd
Braeside VIC 3195
Country
Australia
Secondary sponsor category [1] 288816 0
None
Name [1] 288816 0
Address [1] 288816 0
Country [1] 288816 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291817 0
Sydney University Human Ethics Committee
Ethics committee address [1] 291817 0
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 291817 0
Australia
Date submitted for ethics approval [1] 291817 0
Approval date [1] 291817 0
13/08/2009
Ethics approval number [1] 291817 0
08-2009/12029

Summary
Brief summary
A phytochemical- and mineral-rich filtered sugarcane molasses concentrate (FMC), when added to carbohydrate-containing foods as a functional ingredient, lowers postprandial blood glucose and insulin responses. We hypothesized that this beneficial effect would also occur if FMC was administered as an oral supplement taken before a meal. This study measured the postprandial glucose and insulin responses elicited by different doses of FMC administered immediately prior to a standard breakfast to healthy subjects. Each subject was given three or five breakfast meals once, on different days. The composition of the meals was identical, except for the addition of either placebo syrup (Test Meal 1), or increasing doses of FMC (Test Meals 2-5).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52150 0
Prof Jennie Brand-Miller
Address 52150 0
Sydney University Glycemic Index Research Service (SUGiRS)
Human Nutrition Unit
School of Molecular Bioscience GO8
Sydney University, NSW, 2006
Country 52150 0
Australia
Phone 52150 0
+61 2 9351 6018
Fax 52150 0
Email 52150 0
jennie.brandmiller@sydney.edu.au
Contact person for public queries
Name 52151 0
Dr Tim Ellis
Address 52151 0
Horizon Science
6/84-90 Lakewood Blvd
Braeside VIC 3195
Country 52151 0
Australia
Phone 52151 0
+61 3 9580 9833
Fax 52151 0
Email 52151 0
tim.ellis@horizonscience.com
Contact person for scientific queries
Name 52152 0
Dr Tim Ellis
Address 52152 0
Horizon Science
6/84-90 Lakewood Blvd
Braeside VIC 3195
Country 52152 0
Australia
Phone 52152 0
+61 3 9580 9833
Fax 52152 0
Email 52152 0
tim.ellis@horizonscience.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary