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Trial registered on ANZCTR


Registration number
ACTRN12614000264684
Ethics application status
Approved
Date submitted
24/02/2014
Date registered
11/03/2014
Date last updated
11/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of activity after eating on blood glucose concentration in a group of young adults
Scientific title
Effect on glycaemia of postprandial activity at 5 and 30 minutes in a healthy adult population: randomised crossover study
Secondary ID [1] 284120 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemic control 291196 0
Condition category
Condition code
Metabolic and Endocrine 291533 291533 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy overnight (10 hour) fasted adults will be given a test meal of white bread containing 50g of available carbohydrate. The protocol for GI testing of a food product will be followed, with capillary blood samples take at baseline, 15, 30, 45, 60, 90 and 120 minutes post meal ingestion to observe changes in blood glucose levels over this time. These data points will be used to determine each participants (n=90) incremental area under the curve (iAUC) of blood glucose as a response to meal ingestion.

This process will be repeated for each participant as part of a crossover design with a two week washout, with one arm a control in which participants remain sedentary for 2h after eating. For the other study arm participants will use a seated exercycle at low RPM and low resistance for ten minutes after 5 or 30 minute after finishing eating. (n=90 control, N=45 cycle at 5mins, n=45 cycle at 30mins). the process will be randomized by both order of intervention and timing of exercise.

A secondary element to this study will compare baseline fasted blood glucose capillary measures (captured as part of the iAUC process) with glycated albumin (GA), a mid-term marker for glycaemic control. A possible correlation between fasted blood glucose, postprandial glucose (sedentary condition) and GA will be reviewed. GA assessment will be undertaken on frozen samples of participant blood (taken by capillary as part of the iAUC process) after the intervention has occurred. Participants will have access to their own data, investigators will de-identify and use pooled data for group analysis.
Intervention code [1] 288811 0
Lifestyle
Intervention code [2] 288812 0
Early detection / Screening
Comparator / control treatment
Crossover study, the control arm of this study will be to remain seated (sedentary) for the 2h post test meal ingestion.
Control group
Active

Outcomes
Primary outcome [1] 291501 0
Difference in pooled iAUC values between sedentary (control) and 10 minute exposure to very light physical activity commencing either 5 or 30 minutes post-ingestion.
Timepoint [1] 291501 0
The iAUC taken from two x 2h postprandial blood glucose profiles, one taken with the participant sedentary for 2 hours after eating and the other, a 2 hour period after eating that includes 10 minutes of activity
Primary outcome [2] 291502 0
Correlation coefficient between fasting blood glucose concentration (mmol/L) obtained from capillary blood; postprandial blood glucose area under the curve (mmol/l x min) obtained from a series of capillary blood samples, and glycated albumin from a fasting capillary blood sample.
Timepoint [2] 291502 0
Capillary blood samples will be taken at baseline (before exposure to the test meal) for assessing both fasting blood glucose and glycated albumin. Capillary blood samples will also be taken at baseline, 15, 30, 45, 60, 90 and 120 minutes after baseline for postprandial blood glucose area under the curve.
Secondary outcome [1] 306912 0
Nil
Timepoint [1] 306912 0
Nil

Eligibility
Key inclusion criteria
Healthy free-living adults
Minimum age
18 Years
Maximum age
75 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; who are taking any medications that affect glucose tolerance; that suffer from food allergies; and women who are pregnant or currently lactating.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be university students enrolled at the University of Otago, New Zealand. Participation is optional, with no negative repercussions if students decide not to participate. Once consent is gained, each participant is centrally randomized by computerl to order of intervention and timing of physical activity. Allocation is concealed. As a crossover study, each participant will undergo both arms of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation occurred independently of class enrollment or any participant details, using a computer generated process to randomise both order of intervention and timing of the physical activity undertaken (at 5 or 30 minutes post meal ingestion).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All elements of the study are to be standardised within our ability to isolate variables being compared. Only de-identified pooled data will be used in statistical analysis to minimise discrepancies in individual results. the fasting period will be specified with each participant asked to standardise their meals for carbohydrate load and physical activity level for the 24hours preceding the test meal.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pooled iAUC values will be compared between controlled and intervention arms. mean and standard deviation will be compared, as will the probability of variance between intervention arms. Log transformation may occur if the data is percieved to be skewed (although the randomisation of trial order and exercise timing should minimise the possibility of this). A sample of 35 will have 90% power to detect a clinically relevant 20% difference in iAUC with an alpha of 0.05.

A correlation coefficient will be used to examine any possible relationship between fasting blood glucose and glycated albumin. A sample of 31 will be sufficient to detect a correlation coefficient of 0.5 or better with power of 90% and an alpha of 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2014
Actual
28/02/2014
Date of last participant enrolment
Anticipated
14/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 5839 0
New Zealand
State/province [1] 5839 0
Otago

Funding & Sponsors
Funding source category [1] 288750 0
University
Name [1] 288750 0
University of Otago
Country [1] 288750 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin Otago 9010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287446 0
None
Name [1] 287446 0
Address [1] 287446 0
Country [1] 287446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290590 0
University of Otago Human Ethics Committee
Ethics committee address [1] 290590 0
PO Box 56
Dunedin Otago 9010
Ethics committee country [1] 290590 0
New Zealand
Date submitted for ethics approval [1] 290590 0
Approval date [1] 290590 0
07/02/2014
Ethics approval number [1] 290590 0
13/022

Summary
Brief summary
The aim of this study is to evaluate the effect of very low intensity physical activity on blood sugar levels in healthy adults, after eating. It is a commonly controlled for belief in studys on glycaemia that very light activities such as standing and walking after eating may impact the blood sugar response to a meal. We aim to test this by comparing group data of a sedentary control against very light physical activity at 5 and 30 minutes after eating. We will be examining the 2 hours directly after the consumption of 2 serves of bread.

A secondary aim is to evaluate the potential of a relationship in fasting blood glucose and the level of glycated albumin, a blood protein, in healthy adults. Fasting blood glucose is marker of short term glycaemic control, where glycated albumin is an emerging mid-term marker of glycaemic control. A positive correlation or relationship between the two markers will further affirm the credibility of glycated albumin for use in glycaemic monitoring and surveillance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46326 0
Dr Bernard Venn
Address 46326 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin Otago 9010
Country 46326 0
New Zealand
Phone 46326 0
+643 479 5068
Fax 46326 0
Email 46326 0
[email protected]
Contact person for public queries
Name 46327 0
Bernard Venn
Address 46327 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin Otago 9010
Country 46327 0
New Zealand
Phone 46327 0
+643 479 5068
Fax 46327 0
Email 46327 0
[email protected]
Contact person for scientific queries
Name 46328 0
Bernard Venn
Address 46328 0
University of Otago
Department of Human Nutrition
PO Box 56
Dunedin Otago 9010
Country 46328 0
New Zealand
Phone 46328 0
+643 479 5068
Fax 46328 0
Email 46328 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
SourceTitleYear of PublicationDOI
EmbaseThe timing of activity after eating affects the glycaemic response of healthy adults: A randomised controlled trial.2018https://dx.doi.org/10.3390/nu10111743
N.B. These documents automatically identified may not have been verified by the study sponsor.