Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000640606
Ethics application status
Approved
Date submitted
7/06/2014
Date registered
18/06/2014
Date last updated
18/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining effects of whole grain cereals on weight and metabolic markers in humans
Scientific title
Will eating polyphenol-rich whole grain cereal foods, whilst following a weight reduction diet, result in greater weight loss and improved metabolic markers in overweight and obese adults?
Secondary ID [1] 284731 0
Nil
Universal Trial Number (UTN)
U1111-1157-9900
Trial acronym
GWS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 292083 0
Metabolic Syndrome 292084 0
Appetite regulation 292085 0
Condition category
Condition code
Diet and Nutrition 292425 292425 0 0
Obesity
Metabolic and Endocrine 292504 292504 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 month double blinded parallel randomised controlled trial with 2 arms: control (standard grain diet) and intervention (polyphenol-rich grain diet). All subjects are blinded to their control/intervention group status. Both control and intervention arms will attend the clinic at baseline, 1, 2, 3mo for a face-to-face session with an Accredited Practising Dietitian. Duration of sessions are upto 1.5h at baseline and 30-45 minutes for other visits. All subjects receive identical dietary advice, but the intervention group will receive polyphenol-rich cereal products (124.5mg gallic acid equivalents per 60g of cereal per day) and the control group will receive standard cereal products (75.6mg gallic acid equivalents per 60g of cereal). These polyphenols are the natural levels in the processed products. All diets are based on the core food groups outlined in the Australian Guide to Healthy Eating. Prescribed energy intakes will be calculated to equate to individuals’ estimated energy requirements using the Schofield equation and applying a physical activity factor of 1.3. Cereals provided were modelled into the dietary prescription to achieve macronutrient intakes of approximately 50% energy from carbohydrates, 20% from protein and 30% from fat. Adherence to diets will be monitored using repeated 3-day food records at midpoint (6 weeks) and at 3 months, as well as through dietary interviews at 1mo, 2mo and 3 mo.
Intervention code [1] 289514 0
Treatment: Other
Comparator / control treatment
Control cereal food products will be based on a wholegrain cereal different to the test products - equal in mass (60g) and with similar macronutrient profile and fibre content but with lower polyphenol levels (75.6mg gallic acid equivalents per 60g of cereal). Control participants will follow the same weight reduction diet as the intervention participants, but will receive standard cereal products as described.
Control group
Active

Outcomes
Primary outcome [1] 292286 0
Body weight (kg) will be measured in an upright position in minimal clothing and without shoes using electronic scales (Tanita TBF-662).
Timepoint [1] 292286 0
Baseline, 1 month, 2 months, 3 months
Primary outcome [2] 292364 0
Percentage body fat (%) will be measured in an upright position in minimal clothing and without shoes, estimated by scales with a bio-electrical impedance component (Tanita TBF-662).
Timepoint [2] 292364 0
Baseline, 1 month, 2 months, 3months.
Secondary outcome [1] 308632 0
Dietary intake will be assessed using diet history interview at clinic visits and 3 day food records (including one weekend day) completed in the periods prior to attending the clinic on visit 1 (baseline) and visit 4 (3 months). Participants record all foods consumed including amounts and recipes.
Timepoint [1] 308632 0
Baseline, 1 month, 2 months, 3 months
Secondary outcome [2] 308633 0
Fasting blood lipids (cholesterol, LDL, HDL, Trig),
Blood samples collected at Clinical Trials Unit at IHMRI (Illawarra Health and Medical Research Institute) by a qualified phlebotomist and will be appropriately shipped to an accredited laboratory for analysis.
Timepoint [2] 308633 0
Baseline, 3 months
Secondary outcome [3] 308634 0
Fasting blood glucose, insulin, HbA1c
Blood samples collected at Clinical Trials Unit at IHMRI by qualified phlebotomist and will be appropriately shipped to an accredited laboratory for analysis.
Timepoint [3] 308634 0
Baseline, 3 months
Secondary outcome [4] 308635 0
Plasma inflammatory markers (IL1 beta, TNF alpha, IL6, IFN gamma, hsCRP)
Blood samples collected at Clinical Trials Unit at IHMRI by qualified phlebotomist and will be appropriately shipped to an accredited laboratory for analysis.
Timepoint [4] 308635 0
Baseline, 3 months
Secondary outcome [5] 308636 0
Plasma total antioxidant capacity (TAC) and protein carbonyls
Blood samples collected at Clinical Trials Unit at IHMRI by qualified phlebotomist and will be appropriately shipped to an accredited laboratory for analysis.
Timepoint [5] 308636 0
Baseline, 3 months
Secondary outcome [6] 308637 0
Perception of satiety as measured by 10mm Visual Analogue Scales (VAS) to be completed for one day prior to attending the clinic at the corresponding timepoints listed
Timepoint [6] 308637 0
Baseline, 1 month, 2 months, 3 months
Secondary outcome [7] 308638 0
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured using the Omron BP-203RPEIII VP-1000 device (Omron Health Care, Kyoto, Japan). Measurements to be collected at the end of 5 min resting period in supine position.
Timepoint [7] 308638 0
Baseline, 1 month, 2 months, 3 months

Eligibility
Key inclusion criteria
Men and women from the Illawarra community (adults aged 18-65 years, permanent resident, community dwelling), at higher risk of lifestyle related disease defined by current risk factors such as hypertension, impaired glucose tolerance, hyperlipidaemia and BMI range 25-35kg/m2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe medical conditions impairing ability to participate in study; BMI<25 and >35; eating habits incompatible with study goals including food allergies; reported illegal drug use or regular alcohol intake associated with alcoholism (>50g/day); pregnant, breastfeeding and post-menopausal women; difficulties or major impediments to participating in the components of the study including aversion to consuming wholegrain cereal products daily for breakfast and a snack; inadequate conversational English

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)
Participants will be drawn from the general public through media
advertisements (local newspapers), institutional electronic messaging to students and staff of UOW and local school newsletters
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher independent of the participant interface will undertake the randomisation of subjects into diet groups (stratified by sex, block randomized using STATA V12 and using the RALLOC command)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model to allow partial datasets, incorporating all available data regardless of whether or not the subject completes the study. The planned contrasts are between the control and the intervention groups.
The sample size was chosen based on previous human intervention studies incorporating cereal/high fibre foods in hypo-caloric diets. Differences in weight loss were used as the primary outcome measure to establish power for the study. Based on a weight difference between groups of two kilograms at a power of 80%, 26 subjects per group (52 subjects in total) is required. However, assuming a drop-out rate of 15-20% commonly observed in these types of studies, the required sample target will be set at 30 subjects per group. Therefore, 60 subjects (men and women) will be randomised into a control and intervention group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8226 0
2500 - Wollongong
Recruitment postcode(s) [2] 8227 0
2522 - University Of Wollongong

Funding & Sponsors
Funding source category [1] 289349 0
University
Name [1] 289349 0
University of Wollongong
Country [1] 289349 0
Australia
Funding source category [2] 289350 0
Commercial sector/Industry
Name [2] 289350 0
Sanitarium Health and Wellbeing
Country [2] 289350 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue, Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 288034 0
Commercial sector/Industry
Name [1] 288034 0
Sanitarium Health and Wellbeing
Address [1] 288034 0
1 Sanitarium Drive, Berkeley Vale, NSW, 2261
Country [1] 288034 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291117 0
University of Wollongong (UOW) and ISLHD Health and Medical Human Research Ethics Committee
Ethics committee address [1] 291117 0
Ethics committee country [1] 291117 0
Australia
Date submitted for ethics approval [1] 291117 0
Approval date [1] 291117 0
02/05/2014
Ethics approval number [1] 291117 0
HE14/100

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

Contacts
Principal investigator
Name 48930 0
A/Prof Eleanor Beck
Address 48930 0
School of Medicine; SMART Foods Centre; Illawarra Health and Medical Research Institute; Faculty of Science, Medicine and Health
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country 48930 0
Australia
Phone 48930 0
+ 61 2 42 981271
Fax 48930 0
Email 48930 0
[email protected]
Contact person for public queries
Name 48931 0
Anita Needham
Address 48931 0
School of Medicine; SMART Foods Centre; Illawarra Health and Medical Research Institute; Faculty of Science, Medicine and Health
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country 48931 0
Australia
Phone 48931 0
+ 61 458850088
Fax 48931 0
Email 48931 0
[email protected]
Contact person for scientific queries
Name 48932 0
Anita Needham
Address 48932 0
School of Medicine; SMART Foods Centre; Illawarra Health and Medical Research Institute; Faculty of Science, Medicine and Health
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country 48932 0
Australia
Phone 48932 0
+ 61 458850088
Fax 48932 0
Email 48932 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Diet Enriched with Red Sorghum Flaked Biscuits, Compared to a Diet Containing White Wheat Flaked Biscuits, Does Not Enhance the Effectiveness of an Energy-Restricted Meal Plan in Overweight and Mildly Obese Adults.2017https://dx.doi.org/10.1080/07315724.2016.1237314
N.B. These documents automatically identified may not have been verified by the study sponsor.