Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000507189
Ethics application status
Approved
Date submitted
22/03/2019
Date registered
28/03/2019
Date last updated
28/10/2021
Date data sharing statement initially provided
28/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of gender and the oral contraception pill on acute protein induced thermogenesis
Scientific title
The influence of gender and the oral contraception pill on acute protein induced thermogenesis in healthy adult males and females.
Secondary ID [1] 297758 0
Nil known
Universal Trial Number (UTN)
U1111-1230-3940
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 312099 0
The effect of sex hormones on postprandial metabolism 312115 0
Condition category
Condition code
Diet and Nutrition 310658 310658 0 0
Obesity
Metabolic and Endocrine 310659 310659 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a study of 45 healthy adults aged 18-40 years old, normal and slightly overweight (BMI 18.5 - 27.0). 15 of the participants will be men, 15 women who are users of the combined oral contraceptive pill (OCP+) and 15 women who are not using a hormonal method of contraception (OCP-). We will measure metabolic response to a test meal of known protein content after a 12 hour fast (water allowed) by indirect calorimetry. The test meal will comprise a simple breakfast meal base (toast, butter, jam) with either a dairy based drink to which protein powder may be added to increase the protein content as necessary, or non-dairy drink (coconut milk base). The energy provided by the isocaloric test meals is 2468 kJ, (590kcal), typical of a light meal. Participants will be asked to consume the test meal within 10 minutes. Each participant will attend the Human Nutrition Unit in central Auckland 3 times over approximately 2 months, and consume a test meal of differing protein content at each visit. The protein content of the meal is either low (5%), normal/control (11%) or high (25%). Each visit being a maximum of 6 hrs in length, and there will be a minimum / maximum interval between visits of 2 days / 2 months respectively for individual participants. A subset of OCP+ women will be invited to return for an additional 2 visits during their inactive pill phase. A small dose of soluble paracetamol (1.5g) dissolved in 100ml of water will be given for participants to drink with the meal, in order to measure the rate of gastric emptying, as paracetamol is not well absorbed in the stomach, but is in the small intestine. The protocol for administration of the meal and paracetamol will be the same at each visit, with adherence assessed by the research personnel supervising, who will be present in the room with the participant during this time. The time taken to consume the entire test meal and paracetamol will be recorded at each visit. Indirect calorimetry measurement will be untaken by PhD student and assisted by a research assistant, each experienced in such measurements, who have both been trained in the procedure by Dr. Jennifer Miles-Chan, a Senior Research fellow with approximately 10 years post doctorate experience in this technique. Prior to indirect calorimetry measurement, a cannula will be inserted into a participant's vein by a trained nurse, to allow blood sampling (8 samples taken, total 79ml) over the 4.5hr of measurement. During the indirect calorimetry measurement, participants will be seated and will be able to watch a calm movie and/or documentary from a selection available in order to pass the time.
Intervention code [1] 313997 0
Other interventions
Comparator / control treatment
We will conduct the acute meal challenge 3 times for each participant, using meals of 3 differing protein contents, the participants acting as their own comparator. The test meals will be either low (5%), normal (11%) or high (25%) protein content, with the normal (11%) meal considered as the control.
Control group
Active

Outcomes
Primary outcome [1] 319504 0
Metabolic rate (energy expenditure) measured by indirect calorimetry using an open circuit ventilated hood system
Timepoint [1] 319504 0
Baseline (fasted) T-30 to T0 minutes.
Post prandial - continuous measurement from T15 to T245
There is no primary time point as we will look at area under the curve (AUC).
Primary outcome [2] 319505 0
Appearance of paracetamol in plasma as assessed by HPLC (High Performance Liquid Chromatography).
Timepoint [2] 319505 0
Baseline fasted T-30 minutes.
Post prandial T15 mins, T30 mins, T60 mins, T90 mins, T120 mins, T180 mins, T240 mins.
There is no primary time point as we will look at area under the curve (AUC).
Primary outcome [3] 319565 0
Plasma profile of metabolic biomarkers (glucose, insulin) as assessed by Roche/ Hitachi Cobas auto-analyser and multiplex assays. This is a composite outcome.
Timepoint [3] 319565 0
Baseline (fasted) T-30mins
Post prandial - T15mins, T30mins, T60mins, T90mins, T120mins, T180mins, T240mins, T280mins
Secondary outcome [1] 368549 0
Blood Pressure as measured by Welch Allyn ProBP 2400 electronic blood pressure device.
Timepoint [1] 368549 0
Baseline (fasted) T-30mins
Post prandial - T60mins, T120mins, T180mins, T240mins, T280mins
Secondary outcome [2] 368550 0
Body temperature measured by tympanic thermometer (Braun thermoscan Pro 6000)
Timepoint [2] 368550 0
Baseline (fasted) T-30mins
Post prandial - T240mins, T280mins
Secondary outcome [3] 368551 0
Appetite as measured by Visual Analogue Scales (as a composite outcome derived from hunger, fullness, ability to eat, comfort and nausea).
Timepoint [3] 368551 0
Baseline (fasted) T-30mins, T-15mins, T0mins
Post prandial - T15mins, T30mins, T60mins, T90mins, T120mins, T180mins, T210mins, T240mins, T280mins
Secondary outcome [4] 368552 0
Energy intake as measured by an ad lib consumption of a standardised lunch meal. All food items will be double weighed before and after the lunch meal and dietary analysis software will be used to calculate the amount of energy consumed.
Timepoint [4] 368552 0
T250mins
Secondary outcome [5] 368553 0
Plasma profile of biomarkers of cardiovascular risk (total cholesterol, triglycerides and other exploratory biomarkers dependent on primary outcome) as assessed by Roche/Hitachi Cobas auto-analyser and multiplex assays. This is dependent on primary outcomes 1 and 3.
Timepoint [5] 368553 0
Baseline T-30
Secondary outcome [6] 368554 0
Plasma profile of inflammatory biomarkers (CRP, TNF-a and other exploratory biomarkers dependent on primary outcome) as assessed by Roche/Hitachi Cobas auto-analyser and multiplex assays. This is dependent on primary outcomes 1 and 3.
Timepoint [6] 368554 0
Baseline (fasted) T-30mins
Secondary outcome [7] 368555 0
Plasma profile of gut peptides, as markers of appetite control as assessed by Roche/ Hitachi Cobas auto-analyser and multiplex assays.This outcome is exploratory, dependent on all 3 primary outcomes.
Timepoint [7] 368555 0
Baseline (fasted) T-30mins
Post prandial - T15mins, T30mins, T60mins, T90mins, T120mins, T180mins, T240mins, T280mins
Secondary outcome [8] 368556 0
Plasma profile of hormones as assessed by Roche/ Hitachi Cobas auto-analyser and multiplex assays. This outcome is exploratory, dependent on all 3 primary outcomes.
Timepoint [8] 368556 0
Baseline (fasted) T-30mins
Secondary outcome [9] 368557 0
Heart rate as assessed by chest belt (Garmin)
Timepoint [9] 368557 0
Continuous measurement from T-30 to T245min

Eligibility
Key inclusion criteria
Provision of informed consent
Adults aged 18-40 years
BMI 18.5 - 27.0
Self reported healthy
For female participants OCP+, regular (>3 months) of a combined oral contraceptive pill, as per manufacturers instructions i.e. with regular withdrawl bleeding.
For female participants OCP-, no hormonal method of contraceptive used for at least 3 months, with regular menses.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of chronic disease, or endocrine disorder (both males and females)
Breast feeding, pregnancy or history of menstrual disorder (females)
Use of any medication during the last 3 months (other than the combined oral contraceptive pill for OCP+ women)
Allergy or adverse reaction to paracetamol
Vegetarian
Claustrophobia

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A sample size of n=45 in total (15 per group, men, women OCP+, women OCP-) was determined necessary to detect a significant change (0.5 kcal/min) in energy expenditure (primary variable) as measured by indirect calorimetry, and a within participant variance of energy expenditure of 0.04 kcal/min (SD). This sample size calculation is based on the assumption of a three treatment, cross-over design, significance p <0.05, and 90% power.
Outcome variables will be assessed using a variety if statistical methods including repeated measures ANOVA, Pearson's correlation testing, and mixed model linear regression analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2019
Actual
17/04/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
14/09/2020
Date of last data collection
Anticipated
31/03/2021
Actual
26/09/2020
Sample size
Target
45
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 21361 0
New Zealand
State/province [1] 21361 0
Auckland

Funding & Sponsors
Funding source category [1] 302282 0
Government body
Name [1] 302282 0
Health Research Council
Country [1] 302282 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Jennifer Miles-Chan
Address
Senior Lecturer,
School of Biological Siences,
University of Auckland,
Private Bag 92019,
Auckland mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 302156 0
University
Name [1] 302156 0
University of Auckland Research Office
Address [1] 302156 0
Level 10, Building 620,
Symonds Street,
Auckland 1010
Country [1] 302156 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302958 0
Health and Disabilities Ethics Committee (Southern Committee)
Ethics committee address [1] 302958 0
Ethics committee country [1] 302958 0
New Zealand
Date submitted for ethics approval [1] 302958 0
24/01/2019
Approval date [1] 302958 0
19/03/2019
Ethics approval number [1] 302958 0
19/STH/30

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91978 0
Miss Julia Cree
Address 91978 0
PhD student,
Human Nutrition Unit,
University of Auckland,
18 Carrick Place,
Mt. Eden,
Auckland 1024
Country 91978 0
New Zealand
Phone 91978 0
+64 6301162
Fax 91978 0
Email 91978 0
[email protected]
Contact person for public queries
Name 91979 0
Julia Cree
Address 91979 0
PhD student,
Human Nutrition Unit,
University of Auckland,
18 Carrick Place,
Mt. Eden,
Auckland 1024
Country 91979 0
New Zealand
Phone 91979 0
+64 6301162
Fax 91979 0
Email 91979 0
[email protected]
Contact person for scientific queries
Name 91980 0
Julia Cree
Address 91980 0
PhD student,
Human Nutrition Unit,
University of Auckland,
18 Carrick Place,
Mt. Eden,
Auckland 1024
Country 91980 0
New Zealand
Phone 91980 0
+64 6301162
Fax 91980 0
Email 91980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial, after de-identification, underlying published results only.
When will data be available (start and end dates)?
Availability start immediately following publication, no end date determined.
Available to whom?
Case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
Only to achieve aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by the principal investigator, with a requirement to sign data access agreement.


What supporting documents are/will be available?




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.