Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000979459
Ethics application status
Approved
Date submitted
16/07/2016
Date registered
25/07/2016
Date last updated
25/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acute effect of chocolate consumption on appetite in postmenopausal women
Scientific title
The acute effect of chocolate consumption on appetite in postmenopausal women
Secondary ID [1] 289641 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appetite regulation 299435 0
Condition category
Condition code
Diet and Nutrition 299416 299416 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a randomised within-subjects cross-over design, post-menopausal women will complete three experimental trials (plus an introductory session) at the School of Sport Science, Exercise and Health, The University of Western Australia. A washout period of one week will occur between each of the four sessions. Participants will be supervised for the duration of all sessions and instructed to complete a food diary and abstain from caffeine, alcohol, chocolate and vigorous physical activity in the 24 h prior to the introductory session and to replicate this in the 24 h prior to each experimental session. At each session, women will have 15min to consume one of the following chocolate treatments (2099 kJ each); (a) 84 g of a high concentration cocoa (80%) ‘dark’ chocolate, (b) 87 g of a lower concentration cocoa (35%) ‘milk’ chocolate and (c) 85 g of a cocoa butter ‘white’ chocolate (0% cocoa solids). Measures of perceived appetite, mood and the circulating concentration of appetite-related peptides will be assessed pre- and post-ingestion. In addition, ad libitum energy intake will be assessed 90 minutes following chocolate administration. Each session will be approximately 2 hours in duration.
Intervention code [1] 295257 0
Lifestyle
Comparator / control treatment
The three chocolate conditions will be isocaloric, but contain varied polyphenol content to assess a dose response (80% cocoa 'dark' chocolate (395 mg polyphenols), a 35% cocoa 'milk' chocolate (200 mg polyphenols) and a cocoa butter 'white' chocolate (35 mg polyphenols).
Control group
Dose comparison

Outcomes
Primary outcome [1] 298885 0
Ad libitum energy intake assessed from a laboratory test meal.
Timepoint [1] 298885 0
90 min post-chocolate consumption.
Secondary outcome [1] 325537 0
Perception of appetite will be assessed using a modified 100 mm visual analogue scale (VAS). Briefly, this will involve answering four questions anchored with words representing opposing extreme states of fullness, hunger, desire to eat and prospective food consumption respectively (i.e. “how hungry do you feel?” anchored by “not hungry at all” and “as hungry as I have ever felt”).
Timepoint [1] 325537 0
Pre (baseline/fasting) and post chocolate consumption (0 min, 30 min and 90 min post-ingestion).
Secondary outcome [2] 325538 0
Circulating appetite-related hormones. Venous blood will be sampled from an antecubital vein and immediately combined with 160 microlitres of serine protease inhibitor (Pefabloc SC, Roche Diagnostics, NSW, Australia) before being centrifuged at 4 degrees Celsius, 1000 g for 10 min with the plasma stored at -80 degrees Celsius. Samples will later be analysed in duplicate for a range of appetite-related peptides including active ghrelin, insulin, leptin and pancreatic polypeptide (PP) using a commercially available assay kit (Milliplex Human Gut Hormone Panel, Millipore Corporation, Billerica, MA, USA) according to the manufacturer's instructions on a Luminex 200 system (Luminex Corp., Austin, Texas, USA).
Timepoint [2] 325538 0
Pre (baseline/fasting) and post chocolate consumption (30 min and 90 min post-ingestion).
Secondary outcome [3] 325760 0
Mood will be assessed using the profile of mood states – adolescent inventory (POMS-A) questionnaire (Terry et al., 2003). With a response set of “How do you feel right now?” participants will rate the 24 mood states on a scale from “not at all” to “extremely”.
Timepoint [3] 325760 0
Pre (baseline/fasting) and post chocolate consumption (0 min, 30 min and 90 min post-ingestion).
Secondary outcome [4] 325801 0
Plasma glucose. Venous blood will be sampled from an antecubital vein and be immediately analysed for blood glucose using a Radiometer.
Timepoint [4] 325801 0
Pre (baseline/fasting) and post chocolate consumption (30 min and 90 min post-ingestion).

Eligibility
Key inclusion criteria
Healthy, postmenopausal women aged 50-65 yr. They must like eating all types of chocolate (white, milk, dark).
Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who are taking any prescribed medication, have diabetes or an eating disorder, who are currently on a weight loss diet or smokers.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Within-subject, counterbalanced design

Blinding: Participants will be blindfolded whilst consuming each chocolate condition and will therefore be blinded to the amount and somewhat to the type of chocolate they will consume as milk and dark chocolate are indistinguishable in taste.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is anticipated that a sample size of 14 participants will allow for the detection of a difference in ad libitum energy intake of 400 kJ between trials (power 0.8; p < 005). The effect of the chocolate conditions on ad libitum energy intake will be assessed using one-way (condition) repeated measures analysis of variance (ANOVA). Area under the curve for perceived appetite (hunger, fullness, desire to eat and prospective food consumption) following chocolate consumption will be calculated using the trapezoidal rule and compared between conditions using one-way repeated measures ANOVA. Mood, blood glucose and appetite-related hormones will be compared using two-way (condition x time) repeated measures ANOVA. Post hoc paired t-tests (Least Significant Difference) will be used to determine the specific time-points where differences lay (P = 0.05)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
1/08/2015
Date of last data collection
Anticipated
15/04/2016
Actual
15/04/2016
Sample size
Target
14
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 13578 0
6009 - Crawley

Funding & Sponsors
Funding source category [1] 294021 0
University
Name [1] 294021 0
The University of Western Australia
Country [1] 294021 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
School of Sport Science, Exercise and Health, The University of Western Australia, 35 Stirling Highway, Crawley, WA, Australia, 6009
Country
Australia
Secondary sponsor category [1] 292901 0
None
Name [1] 292901 0
Address [1] 292901 0
Country [1] 292901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295433 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 295433 0
Ethics committee country [1] 295433 0
Australia
Date submitted for ethics approval [1] 295433 0
20/01/2015
Approval date [1] 295433 0
20/02/2015
Ethics approval number [1] 295433 0
RA/4/1/7321

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

Contacts
Principal investigator
Name 67302 0
Miss Channa Marsh
Address 67302 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, Australia, 6009
Country 67302 0
Australia
Phone 67302 0
(+61 8) 6488 2361
Fax 67302 0
Email 67302 0
[email protected]
Contact person for public queries
Name 67303 0
Channa Marsh
Address 67303 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, Australia, 6009
Country 67303 0
Australia
Phone 67303 0
(+61 8) 6488 2361
Fax 67303 0
Email 67303 0
[email protected]
Contact person for scientific queries
Name 67304 0
Channa Marsh
Address 67304 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, Australia, 6009
Country 67304 0
Australia
Phone 67304 0
(+61 8) 6488 2361
Fax 67304 0
Email 67304 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

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