Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001301550
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
30/11/2015
Date last updated
29/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of berry fruits on appetite and food intake: targeting the colonic brake for weight loss
Scientific title
In 20 overweight post-menopausal women, the effect of boysenberry drinks are compared with inulin (positive control) and maltodextrin (placebo) on appetite and food intake.
Secondary ID [1] 287517 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 296278 0
Condition category
Condition code
Diet and Nutrition 296556 296556 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The day after the study visit 1, visit 3 and visit 5 participants start 3 week supplementation of their normal diet with 1 of the 3 treatments. To minimize the potential for gastrointestinal discomfort, the fiber supplementation will be gradually built up over the first 7 days, to a maximum of 3 beverages/day providing a total of 16g fiber/day. As a further precaution only 1 sachet will be consumed with each meal to spread fiber delivery across the day e.g. a single sachet with each meal (breakfast, lunch and dinner). During the build-up on days 1-3, 1 sachet/day taken at breakfast, on days 4-6, two sachets/day with one taken at breakfast and another at dinner; then for days 7-21 three sachets/day with one taken at breakfast, lunch and dinner. All treatments are administered as a beverage, prepared by the participant on the day from a sealed sachet of powder mixed with water. The amount of boysenberry is 48 g containing 16 g of fiber is to be mixed with a minimum of 350 mL of water. The amount of inulin is 42 g containing 16 g of fiber is to be mixed with a minimum of 350 mL of water. Participants will be asked to keep all of the used sachets plus any unused sachet. Our research staff will monitor the participant by telephone three times a week. There will be a minimum of three-week wash-out period in between the treatments.
Intervention code [1] 292909 0
Treatment: Other
Comparator / control treatment
Boysenberry is compared with inulin, and maltodextrin is the placebo. The amount of inulin is 42 g containing 16 g of fiber is to be mixed with a minimum of 350 mL of water. 42 g of maltodextrin containing no fiber is also to be mixed with a minimum of 350 mL of water. Only 1 sachet will be consumed with each meal to spread fiber delivery across the day e.g. a single sachet with each meal (breakfast, lunch and dinner). During the build-up on days 1-3, 1 sachet/day taken at breakfast, on days 4-6, two sachets/day with one taken at breakfast and another at dinner; then for days 7-21 three sachets/day with one taken at breakfast, lunch and dinner.
Control group
Placebo

Outcomes
Primary outcome [1] 296173 0
Ratings of appetite sensations will be assessed using 100 mm visual analogue scale on each visit.
Timepoint [1] 296173 0
This testing will take place at the start and end of each treatment, thus 6 study days in total.
t=0 (pre-breakfast), t=15 (post-breakfast), t=30min, 60min, 90min, 120min,180min, 240min, 270min, 300min, 330min, 360min
Primary outcome [2] 296341 0
Energy intake at a lunch meal. Lunch items will be weighed pre- and post-meal, and energy, fat, CHO and protein intake calculated used the dietary program Foodworks.
Timepoint [2] 296341 0
t=240min, where t=0min is time of breakfast.
Secondary outcome [1] 317695 0
- Gastro-intestinal hormones (GLP-1, CCK and PYY, ghrelin) from blood collection.
Timepoint [1] 317695 0
This testing will take place at the start and end of each treatment, thus 6 study days in total.
t=0 (pre-breakfast), t=15 (post-breakfast), t=30min, 60min, 90min, 120min,180min, 240min, 270min, 300min, 330min, 360min
Secondary outcome [2] 318204 0
Short chain fatty acids from blood collection
Timepoint [2] 318204 0
This testing will take place at the start and end of each treatment, thus 6 study days in total.
t=0min (pre-breakfast)
Secondary outcome [3] 318205 0
Short chain fatty acids from fecal sample
Timepoint [3] 318205 0
Participants will bring their fecal samples collected on the morning of their visit, before and after each treatment period.

Eligibility
Key inclusion criteria
Female
Aged 50-70 years
BMI between 25 and 35 kg/m2
Postmenopausal defined either by age greater than 60 years; or no menopausal cycle in the past 12 months.
Generally healthy, as ascertained by self-report
Minimum age
50 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any reported medical conditions or medications known to affect appetite -related parameters, including depression
Low iron status, hence unsuitable for cannulation studies
Participation in an active diet program and/or loss/gain of >10% body weight within the last 6 months
Smoker or ex-smoker who quit within the last 6 months
Body Mass Index greater than or equal to 35 kg/m2, or less than or equal to 25 kg/m2.
Reported major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
Reported history of active uncontrolled gastrointestinal disorders or diseases including: inflammatory bowel disease (IBD), ulcerative colitis), Crohn's disease or indeterminate colitis; irritable bowel syndrome (IBS) (persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown aetiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated); chronic and recurring constipation of >5 days.
Reported use of any of the following drugs within the last 6 months: systemic antibiotics (intravenous, intramuscular, or oral); corticosteroids (oral, intravenous, intramuscular, nasal or inhaled); cytokines; methotrexate or immunosuppressive cytotoxic agents;
Large doses of commercial probiotics consumed (greater than or equal to108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
Acute disease at the time of enrolment (defer sampling until –participant recovers), included clinically raised blood pressure of >160/100 mm/Hg. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Chronic, clinically significant (unresolved, requiring on-going medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by reported medical history
Reported history of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
Reported positive test for HIV, HBV or HCV.
Hypersensitivities or allergies to any foods or ingredients included in the study
Dislike and/or unwilling to consume items listed as study foods
Unwilling/unable to comply with study protocol
Participating in another clinical intervention trial

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into the 3 treatments 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
Energy intake at the ad lib lunch meal is the primary outcome. Sample size has been calculated using the primary endpoint of energy intake at the ad libitum lunch meal. The power calculations have used the assumptions of outcome differences of 400kJ, equivalent to a change of 10 percent in an individual consuming a typical lunch intake of 4 MJ/day (=4000 kJ/day). In order to inform as to the within-person standard deviation, numbers corresponding to the smallest (686kJ) and largest (990kJ) standard deviation from the previous trial were used.
Paired data (cross-over) – continuous outcome (EI)
Anticipated standardised effect = [anticipated difference in outcome 400kJ]/[sd of difference of outcome variable measured on two occasionsestimated from previous studies]
In order to detect an outcome difference of 5% (500kJ) as significant at P<0.05
(i) = 400/686 = 0.73 80%=17 subjects; 90%=22 subjects
(ii) = 400/990 = 0.51 80%=33 subjects; 90%=42 subjects
Machin, D. et al. Sample Size Tables for Clinical Studies, 3rd Edition, 2008.

The model based upon an estimated error variance taken from the previous study could be larger (or smaller) than previously observed & hence the actual probability of detecting the effect is uncertain. Using the 80% confidence interval (worst case scenario) the number of subjects required is estimated to fall between 17-33 subjects. Based on these calculations, 20 participants will be recruited.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
29/01/2016
Actual
1/02/2016
Date of last data collection
Anticipated
Actual
13/06/2016
Sample size
Target
20
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 7180 0
New Zealand
State/province [1] 7180 0

Funding & Sponsors
Funding source category [1] 292090 0
University
Name [1] 292090 0
University of Auckland Human Nutrition Unit
Country [1] 292090 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Plant and Food Research
Address
120 Mt Albert Road,
Sandringham,
Auckland 1025
Country
New Zealand
Secondary sponsor category [1] 290768 0
University
Name [1] 290768 0
The University of Auckland
Address [1] 290768 0
Level 10, Building 620,
49 Symonds St,
Auckland 1010
Country [1] 290768 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293574 0
Health and Disability Ethics Committees
Ethics committee address [1] 293574 0
Ministry of Health,
Freyberg Building,
20 Aitken Street,
PO Box 5013
Wellington, 6011
Ethics committee country [1] 293574 0
Date submitted for ethics approval [1] 293574 0
23/07/2015
Approval date [1] 293574 0
20/08/2015
Ethics approval number [1] 293574 0
15/NTA/94

Summary
Brief summary
Background: Berryfruits supplementation is predicted to be able to activate satiety mechanisms which may suppress both hunger and food intake.
Objective: The aims of the research are to determine whether berryfruits supplementation suppresses appetite, decreases the amount of food intake, and causes short-term
weight loss.
Design: This will be a 3-treatment cross-over intervention study comprising 20 overweight postmenopausal women. The study will compare two types of dietary fiber (boysenberry, inulin) and a non-fiber placebo (maltodextrin) supplementation. Each treatment will be self-administered 3 times a day for a 3 week period, separated by a minimum 3 weeks break.
Participants will take part in a 4-month study, with 6 study visits to the Human Nutrition Unit.
Outcome variables: Throughout the study visits, ratings of hunger, fullness and appetite related sensations will be measured via questionaires at various time intervals. Blood samples will also be collected different time points throughout the day for appetite hormones measurements. Energy intake will also be measured from the buffet
lunch meal where they can eat as much as they want until comfortably full. In addition, participants will be asked to complete a 3-day food record prior to each study visit to see whether their hunger is changing. Participants will also be asked to take fecal sample prior to each study visit for analysis of short chain fatty acids and microorganisms to investigate whether the berryfruit drinks are altering bateria in their colon.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60518 0
Prof Sally Poppitt
Address 60518 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 60518 0
New Zealand
Phone 60518 0
+649 630 5160
Fax 60518 0
Email 60518 0
[email protected]
Contact person for public queries
Name 60519 0
Mr Wilson Yip
Address 60519 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 60519 0
New Zealand
Phone 60519 0
+649 630 3744
Fax 60519 0
Email 60519 0
[email protected]
Contact person for scientific queries
Name 60520 0
Prof Sally Poppitt
Address 60520 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 60520 0
New Zealand
Phone 60520 0
+649 630 5160
Fax 60520 0
Email 60520 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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