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Trial registered on ANZCTR


Registration number
ACTRN12611000642987
Ethics application status
Approved
Date submitted
30/05/2011
Date registered
23/06/2011
Date last updated
19/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Health benefits of pulses (legumes) in older overweight adults
Scientific title
Impact of pulse-enriched foods on cognitive function and cardiometabolic health in obese adults
Secondary ID [1] 262219 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 267911 0
Cardiometabolic health 267912 0
obesity 267987 0
Condition category
Condition code
Diet and Nutrition 268057 268057 0 0
Obesity
Cardiovascular 268058 268058 0 0
Other cardiovascular diseases
Mental Health 268118 268118 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized, controlled nutrition intervention trial designed to evaluate the health benefits of pulses will be conducted in 160 older overweight adults by a collaborating team from the University of Manitoba and the Nutritional Physiology Research Centre, University of South Australia.
Prior to beginning the trial, volunteers will undergo a series of cognitive and cardiometabolic (blood pressure, blood vessel function, body composition) tests. They will provide a fasting blood sample and their dietary intake and regular physical activity will be assessed.
Volunteers will be allocated to one of two intervention groups:-

1. Pulse group: consume foods delivering 100g of pulses daily for 12 weeks
2. Control group: consume energy matched non-pulse foods for 12 weeks

Cognitive, cardiometabolic, dietary and physical activity assessments and blood sampling will be repeated at 6 and 12 weeks.
Intervention code [1] 266646 0
Lifestyle
Comparator / control treatment
Non-pulse containing foods (energy matched to pulse foods)
Control group
Active

Outcomes
Primary outcome [1] 269003 0
Cerebral vasodilator responsiveness will be measured by Transcranial Doppler (TCD)
Timepoint [1] 269003 0
Baseline (week 0), week 6 and week 12
Secondary outcome [1] 276471 0
Body composition will be assessed by dual energy x-ray absorptiometry (DEXA, specifically fat and lean mass), weight, waist and hip circumference
Timepoint [1] 276471 0
Baseline (week 0), week 6 and week 12
Secondary outcome [2] 276472 0
Arterial compliance and blood pressure will be assessed by the cardiovascular profiler and automatic sphygmomanometer, respectively.
Timepoint [2] 276472 0
Baseline (week 0), week 6 and week 12
Secondary outcome [3] 276473 0
Lipids and lipoproteins will be assessed by serum analysis
Timepoint [3] 276473 0
Baseline (week 0), week 6 and week 12
Secondary outcome [4] 276474 0
Insulin sensitivity will be assessed by serum analysis
Timepoint [4] 276474 0
Baseline (week 0), week 6 and week 12
Secondary outcome [5] 276784 0
Cognitive function will be assessed by a battery of tests including the Rey Auditory Verbal Learning Test (RAVLT), Wechsler Adult Intelligence Scale (WAIS) IV, Controlled Oral Word Association (COWA) and Stroop
Timepoint [5] 276784 0
Baseline (week 0), week 6 and week 12

Eligibility
Key inclusion criteria
overweight/obese (BMI > 25kg/m2), older adults (age 50-80 years) who consume one or less serves per week of pulses.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Body weight exceeding 135kg (maximum capacity of the DEXA scanner) 2.Established cardiovascular, liver or kidney disease 3.Uncontrolled diabetes 4. Use of medication or supplements for management of elevated lipids, blood pressure or glucose that has not been stable for at least 3 months, other medication will be considered at the discretion of the investigators 5.Use of appetite suppressants or Orlistat (Xenical) 6.Inability to consume pulse-enriched foods 7.Pregnancy 8.Smoking or only recently quit smoking (within the last 12 months) 9.Weight loss of 3kg or more in the 6 months prior to enrolling in the study 10.Adherence to a weight loss diet or physical activity program designed to facilitate weight loss 11.Acute or terminal illness 12. Alcohol consumption of more than 4 standard drinks per day.13. Prostheses or implants that are considered by the investigators to influence the accuracy of the body composition scan

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)
Subjects meeting entry criteria at screening will be allocated to a treatment at random using central randomisation by computer. Due to the nature of the study, investigators and subjects will not be blinded to the treatment once they have begun the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
ID numbers will be randomly allocated to treatment in blocks and there will be a rolling recruitment of participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2011
Actual
12/09/2011
Date of last participant enrolment
Anticipated
Actual
11/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 4044 0
5000
Recruitment postcode(s) [2] 4045 0
5001
Recruitment outside Australia
Country [1] 3597 0
Canada
State/province [1] 3597 0
Winnipeg

Funding & Sponsors
Funding source category [1] 267136 0
Government body
Name [1] 267136 0
South Australian Government (DFEEST)
Country [1] 267136 0
Australia
Funding source category [2] 267137 0
Government body
Name [2] 267137 0
Government of Manitoba
Country [2] 267137 0
Canada
Funding source category [3] 267140 0
Government body
Name [3] 267140 0
Australian Federal Government via the Grains Research and Development Corporation
Country [3] 267140 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jon Buckley
Address
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 264213 0
Individual
Name [1] 264213 0
Professor Peter Zahradka
Address [1] 264213 0
St. Boniface Research Ctr
Inst of Cardiovascular Sci
R3040 - 351 Tache Av
Winnipeg MB CANADA
R2H 2A6
Country [1] 264213 0
Canada
Other collaborator category [1] 252021 0
Individual
Name [1] 252021 0
Professor Peter Howe
Address [1] 252021 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide, SA 5001
Country [1] 252021 0
Australia
Other collaborator category [2] 252022 0
Individual
Name [2] 252022 0
Dr Alison Hill
Address [2] 252022 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide, SA 5001
Country [2] 252022 0
Australia
Other collaborator category [3] 252023 0
Individual
Name [3] 252023 0
Dr Alison Coates
Address [3] 252023 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide, SA 5001
Country [3] 252023 0
Australia
Other collaborator category [4] 252024 0
Individual
Name [4] 252024 0
Dr Janet Bryan
Address [4] 252024 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide, SA 5001
Country [4] 252024 0
Australia
Other collaborator category [5] 252025 0
Individual
Name [5] 252025 0
Professor Carla Taylor
Address [5] 252025 0
St. Boniface Research Ctr
Inst of Cardiovascular Sci
R3040 - 351 Tache Av
Winnipeg MB CANADA
R2H 2A6
Country [5] 252025 0
Canada
Other collaborator category [6] 252026 0
Individual
Name [6] 252026 0
Mr Brendon Foot
Address [6] 252026 0
St. Boniface Research Ctr
Inst of Cardiovascular Sci
R3040 - 351 Tache Av
Winnipeg MB CANADA
R2H 2A6
Country [6] 252026 0
Canada
Other collaborator category [7] 252027 0
Individual
Name [7] 252027 0
Dr Michel Aliani
Address [7] 252027 0
St. Boniface Research Ctr
Inst of Cardiovascular Sci
R3040 - 351 Tache Av
Winnipeg MB CANADA
R2H 2A6
Country [7] 252027 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269126 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 269126 0
Ethics committee country [1] 269126 0
Australia
Date submitted for ethics approval [1] 269126 0
06/05/2011
Approval date [1] 269126 0
28/07/2011
Ethics approval number [1] 269126 0
0000024295

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

Contacts
Principal investigator
Name 32638 0
Prof Jon Buckley
Address 32638 0
Nutritional Physiology Research Centre School of Health Sciences University of South Australia PO Box 2471 Adelaide, SA 5001
Country 32638 0
Australia
Phone 32638 0
+61 8 8302 1853
Fax 32638 0
+61 8 8302 2178
Email 32638 0
jon.buckley@unisa.edu.au
Contact person for public queries
Name 15885 0
Dr Alison Hill
Address 15885 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001
Country 15885 0
Australia
Phone 15885 0
+61 8 8302 1817
Fax 15885 0
+61 8 8302 2178
Email 15885 0
alison.hill@unisa.edu.au
Contact person for scientific queries
Name 6813 0
Jon Buckley
Address 6813 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001
Country 6813 0
Australia
Phone 6813 0
+61 8 8302 1853
Fax 6813 0
+61 8 8302 2178
Email 6813 0
jon.buckley@unisa.edu.au

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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