Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000041651
Ethics application status
Approved
Date submitted
11/12/2013
Date registered
16/01/2014
Date last updated
12/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Plant-derived berry extracts and appetite control
Scientific title
Evaluation of hunger, satiety and food intake by comparison of high and low dose plant-derived berry extracts and placebo in a group of 20 healthy male.
Secondary ID [1] 283649 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appetite control 290596 0
Condition category
Condition code
Diet and Nutrition 290983 290983 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
high dose and low dose plant-derived berry extracts.
berry extract is made from Vitis vinifera. dosage is 500mg for low dose and 1500mg for high dose. The berry extracts is only taken once orally. The duration is 1 day for each dose. This is a cross-over study with washout period of minimum 3 days. Participants will be given toast for breakfast along with the berry extracts.
Intervention code [1] 288350 0
Prevention
Comparator / control treatment
placebo will be taken orally and only administered once like the berry extracts and duration is 1 day.
Control group
Placebo

Outcomes
Primary outcome [1] 290969 0
food intake at the ad libitum buffet lunch via weight measurements of the food confirmed.
Timepoint [1] 290969 0
3 hours after breakfast with one of the 3 intervention capsules.
Secondary outcome [1] 305700 0
hunger, fullness, and other satiety ratings. this is a composite outcome. this will be assessed via VAS (visual analogue scales) questionnaire
Timepoint [1] 305700 0
throughout the day at various time point. first hour after breakfast will be every 15min, then every 30min until lunch. Timepoint will be at 0, 15, 30, 45, 60, 90, 120, 150, 180, and 210.

Eligibility
Key inclusion criteria
Male
Age 18-60 years.
Lean (as defined by BMI in the range of 18-28 kg/m2).
Healthy, as ascertained by self-report.
Desire to participate in clinical trial.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant endocrine, cardiovascular, gastrointestinal, metabolic disease or cancer/s including a history of these diseases
Any medical conditions known to affect appetite related research parameters.
Smokers or ex-smokers who had quit within the previous 6 months.
Weight loss/gain of 5kg within the previous 6 months, or taking part in an active diet program such as Jenny Craig, Weight Watchers.
Taking medications for weight loss or other conditions known to affect appetite regulation.
Depression or any other anxiety disorder known to affect appetite.
Hypersensitivities or allergies to any foods or ingredients included in the study.
Unwilling/unable to comply with study protocol.

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)
Participants interested in the study will be contacted by the research staff via phone or email for further information.
The Participant Information Sheet (PIS) will be emailed or posted to the participants.
On the first visit to the Human Nutrition Unit, participants will have an opportunity to ask any questions about the study. If they want to take part, they will be asked to sign the Informed consent form.
The allocation of treatment will be randomised at each study visit via Latin Square randomisation table. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The subjects will be randomised. Randomisation will be carried out using a Latin Square balanced for order of presentation and carry-over effects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
20 participants using power analysis. Using the upper 80% confidence interval (worst canse scenario) the number of subjects required falls between 17-33 subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2014
Actual
18/01/2014
Date of last participant enrolment
Anticipated
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5653 0
New Zealand
State/province [1] 5653 0

Funding & Sponsors
Funding source category [1] 288325 0
Commercial sector/Industry
Name [1] 288325 0
NZ Extracts Limited
Country [1] 288325 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
NZ Extracts Limited
Address
PO Box 549
Blenheim 7240
Marlborough
Country
New Zealand
Secondary sponsor category [1] 287042 0
University
Name [1] 287042 0
University of Auckland Research Office
Address [1] 287042 0
Level 10, Building 620
49 Symonds St
Auckland 1010
Country [1] 287042 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290219 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 290219 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 290219 0
New Zealand
Date submitted for ethics approval [1] 290219 0
25/11/2013
Approval date [1] 290219 0
18/12/2013
Ethics approval number [1] 290219 0

Summary
Brief summary
Background: Plant-origin berry extract is predicted to be able to activate satiety mechanisms which may suppress both hunger and food intake.
Aim: This study aims to measure the effect of encapsulated Plant-origin berry extract consumed with breakfast meal on hunger, appetite and energy intake at a subsequent buffet lunch meal.
Design: This will be a high-dose, low-dose and placebo, crossover intervention study comprising 20 healthy lean male subjects (aged 18-60 years) with both researches and participants blinded to treatment. Participants will be given a standard 2 MegaJoules (MJ) breakfast followed 3 hours later by a lunch meal which is consumed ad lib until the participant is comfortably full.
Outcome variables will be feelings of hunger, fullness and associated appetite sensations as well as energy and macronutrient intake at the ad lib lunch meals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44526 0
Prof Sally Poppitt
Address 44526 0
Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 44526 0
New Zealand
Phone 44526 0
+649 6305160
Fax 44526 0
Email 44526 0
s.poppitt@auckland.ac.nz
Contact person for public queries
Name 44527 0
Mr Wilson Yip
Address 44527 0
Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 44527 0
New Zealand
Phone 44527 0
+649 6303744
Fax 44527 0
Email 44527 0
w.yip@auckland.ac.nz
Contact person for scientific queries
Name 44528 0
Prof Sally Poppitt
Address 44528 0
Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 44528 0
New Zealand
Phone 44528 0
+649 6305160
Fax 44528 0
Email 44528 0
s.poppitt@auckland.ac.nz

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
EmbasePostprandial effects of a polyphenolic grape extract (PGE) supplement on appetite and food intake: A randomised dose-comparison trial.2015https://dx.doi.org/10.1186/s12937-015-0085-1
N.B. These documents automatically identified may not have been verified by the study sponsor.