Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000266066
Ethics application status
Approved
Date submitted
29/03/2010
Date registered
31/03/2010
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of menstrual cycle on the gastrointestinal function, hormone, appetite and energy intake responses to nutrients
Scientific title
Effects of menstrual cycle on the antropyloroduodenal motility, hormone, appetite and energy intake responses to intraduodenal nutrients in healthy female volunteers
Secondary ID [1] 1563 0
nil
Universal Trial Number (UTN)
U1111-1114-5490
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 257045 0
Condition category
Condition code
Diet and Nutrition 257207 257207 0 0
Obesity
Reproductive Health and Childbirth 257225 257225 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive an intraduodenal infusion of intralipid (Registered trademark) (10% given at a rate of 2.8kcal/min or 2.545ml/min) or control (0.9% saline given at a rate of 2.545ml/min) for a duration of 90 minutes on each study day. On two occasions, they will receive infusions of control (saline) and on the other two occasions they will receive lipid (intralipid), once each during the luteal phase and follicular phases. Srudy visits will be separated by 3-14days. Energy intake will be assessed using a weighed buffet meal, immediately after infusion (t=90 minutes).
The buffet meal consists of:
4 slices of wholemeal bread (sunblest (Registered Trademark))
4 slices of white bread (sunblest (Registered Trademark))
100g of deli leg ham (Woolworths)
100g of chicken roll, shaved (Woolworths)
4 Coon Tasty (Registered Trademark) Cheese slices
100g of tomato
100g iceberg lettuce
100g of continental cucumber
600ml of water
300ml of Daily Juice (Registered Trademark) unsweeted orange juice
375m Farmers Union (Registered Trademark) iced coffee
1 medium red delicious apple
1 medium banana
200g of Yogo (Registered Trademark) chocolate custard
150g of Goulburn Valley (Registered Trademark) fruit salad
200g of Yoplait (Registered Trademark) Strawberry yoghurt
25g of Flora (Registered Trademark) margarine
25g of Masterfoods (Registered Trademark) mayonnaise.
Intervention code [1] 256223 0
Behaviour
Intervention code [2] 256236 0
Prevention
Comparator / control treatment
The control (saline) treatment will be given on two of the four study sessions. Once during the follicular and once during the luteal phase of menstrual cycle. The control solution will be given at a rate of 2.545ml/min for a total of 90 minutes per study visit. The buffet meal (immediately after infusion) given to volunteers after the control arm is the same as that used for the intralipid treatment condition, decribed above.
Control group
Placebo

Outcomes
Primary outcome [1] 258101 0
Primary Outcome: Energy intake (measured in kilojoule (kJ) with the weight of food quantified prior to and post consumption buffet meal.
Timepoint [1] 258101 0
At T=120min (after infusion), on each study day
Secondary outcome [1] 263703 0
-Plasma appetite hormones (Cholecystokinin, Peptide YY). Blood samples are collected (requires cannulation of the forearm of subject) and plasma is analysed using radioimmunoassay (RIA).
Timepoint [1] 263703 0
Plasma hormones: measured each study day at T=-15, 0, 15, 30, 45, 60, 75, 90 and 120min.
Secondary outcome [2] 263704 0
-Blood glucose. Blood samples are collected (requires cannulation of the forearm of subject). Glucose levels are determined using a glucometer.
Timepoint [2] 263704 0
Blood glucose: measure each study day at T=-15, 0, 15, 30, 45, 60, 75, 90 and 120min
Secondary outcome [3] 263705 0
-Appetite scores measure by a validated visual analogue scale (VAS).
Timepoint [3] 263705 0
Measure each study day at T=-15, 0, 15, 30, 45, 60, 75, 90, 120min

Eligibility
Key inclusion criteria
To be included, subjects must be healthy females volunteers, must not meet any of the exclusion criteria outlined below:
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-pregnant or breast feeding
-using any contraceptive medication
-smokers
-suffering any significant illnesses (such as diabetes, epilepsy cardiovascular or other respiratory diseases)
-significant gastrointestinal disease
-restrained eaters (measured using a the restraint component of the Three-factor eating questionnaire)
-have any known food allergies
-allergic to anaesthetic,
-suffer from premenstrual symptom (assessed using the premenstrual screening tool)

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)
Each subject after a phone interview is invited to attend the Discipline of Medicine, Univeristy of Adelaide to meet with investigator 1. They will complete questionnaires to assess their dietary restraint, premenstrual symptoms and have their height and weight measured. Once they are determined to be eligble to participate they will be asked to complete a diary noting the timing of their menstrual cycle for no less than 2 months. They are then asked to contact investigator 2, who is the holder of the allocation schedule for the subject randomisation who will randomly allocate subjects to receive the different intervention treatments on set visit dates.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a repeated measures study design where subjects are randomised to the different treatment conditions using randomised table generated using a program from: www.randomisation.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Study terminated before completion due to difficulties in being able to accurately determine the menstrual cycle phase of subjects. This was a critical element of the study to allow for accurate data collection.
Date of first participant enrolment
Anticipated
15/11/2009
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
1/06/2016
Date of last data collection
Anticipated
31/12/2016
Actual
12/10/2016
Sample size
Target
15
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2676 0
5000
Recruitment postcode(s) [2] 2677 0
5006
Recruitment postcode(s) [3] 2678 0
5014
Recruitment postcode(s) [4] 2679 0
5010
Recruitment postcode(s) [5] 2680 0
5024
Recruitment postcode(s) [6] 2681 0
5022
Recruitment postcode(s) [7] 2682 0
5033
Recruitment postcode(s) [8] 2683 0
5031
Recruitment postcode(s) [9] 2684 0
5034
Recruitment postcode(s) [10] 2685 0
5035
Recruitment postcode(s) [11] 2686 0
5038
Recruitment postcode(s) [12] 2687 0
5039
Recruitment postcode(s) [13] 2688 0
5037
Recruitment postcode(s) [14] 2689 0
5043
Recruitment postcode(s) [15] 2690 0
5043
Recruitment postcode(s) [16] 2691 0
5047
Recruitment postcode(s) [17] 2692 0
5062
Recruitment postcode(s) [18] 2693 0
5061
Recruitment postcode(s) [19] 2694 0
5063
Recruitment postcode(s) [20] 2695 0
5045
Recruitment postcode(s) [21] 2696 0
5064
Recruitment postcode(s) [22] 2697 0
5065
Recruitment postcode(s) [23] 2698 0
5066
Recruitment postcode(s) [24] 2699 0
5067
Recruitment postcode(s) [25] 2700 0
5068
Recruitment postcode(s) [26] 2701 0
5069
Recruitment postcode(s) [27] 2702 0
5070
Recruitment postcode(s) [28] 2703 0
5072
Recruitment postcode(s) [29] 2704 0
5073
Recruitment postcode(s) [30] 2705 0
5075
Recruitment postcode(s) [31] 2706 0
5085
Recruitment postcode(s) [32] 2707 0
5087
Recruitment postcode(s) [33] 2708 0
5091
Recruitment postcode(s) [34] 2709 0
5092
Recruitment postcode(s) [35] 2710 0
5098
Recruitment postcode(s) [36] 2711 0
5081

Funding & Sponsors
Funding source category [1] 256725 0
Government body
Name [1] 256725 0
National Health and Medical Research Council
Country [1] 256725 0
Australia
Primary sponsor type
Individual
Name
A/Prof Christine Feinle-Bisset
Address
University of Adelaide, Discipline of Medicine, Level 6, Eleanor Harrald Building, Royal Adelaide Hospital, Frome Rd, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 256008 0
None
Name [1] 256008 0
Address [1] 256008 0
Country [1] 256008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258737 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 258737 0
North Terrace Adelaide SA 5000
Ethics committee country [1] 258737 0
Australia
Date submitted for ethics approval [1] 258737 0
Approval date [1] 258737 0
14/10/2009
Ethics approval number [1] 258737 0
090907

Summary
Brief summary
Each subject will be required to attend the Discipline of Medicine, Royal Adelaide Hospital, on four occasions. They will receive in randomised, double-blind order, infusions of either lipid (Intralipid (Resgistered Trademark) or 0.9% saline. On two occasions, they will receive infusions of saline (control) and on the other two occasions they will receive lipid (once each during the luteal and folicular phases). The primary outcome evaluated will be energy intake assessed using measuring food intake at a buffet meal after the intraduodenal infusion.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30989 0
Address 30989 0
Country 30989 0
Phone 30989 0
Fax 30989 0
Email 30989 0
Contact person for public queries
Name 14236 0
Ms Brydie Clarke
Address 14236 0
University of Adelaide, Discipline of Medicine, Level 6, Eleanor Harrald Building, Royal Adelaide Hospital, Frome Rd, Adelaide, SA, 5000
Country 14236 0
Australia
Phone 14236 0
61882225073
Fax 14236 0
Email 14236 0
[email protected]
Contact person for scientific queries
Name 5164 0
A/Prof Christine Feinle-Bisset
Address 5164 0
University of Adelaide, Discipline of Medicine, Level 6, Eleanor Harrald Building, Royal Adelaide Hospital, Frome Rd, Adelaide, SA, 5000
Country 5164 0
Australia
Phone 5164 0
+61882225247
Fax 5164 0
Email 5164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.