Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01495832




Registration number
NCT01495832
Ethics application status
Date submitted
16/12/2011
Date registered
20/12/2011
Date last updated
25/09/2014

Titles & IDs
Public title
Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults
Scientific title
Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults
Secondary ID [1] 0 0
B2001:084
Universal Trial Number (UTN)
Trial acronym
PULSA-2011
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pulse Group
Other interventions - Control Group

Experimental: Pulse Group - The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.

Active comparator: Control Group - The control group will consume comparator foods for 12 weeks.


Other interventions: Pulse Group
The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.

Other interventions: Control Group
The control group will consume comparator foods for 12 weeks.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Vascular Function
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Cerebral Blood Flow Velocity (Australian Site only)
Timepoint [2] 0 0
12 Weeks
Secondary outcome [1] 0 0
Cognitive Function
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
* Male or females, between 50-80 years of age
* Body Mass Index (BMI) of >25 kg/m2
* Must be on a stable regime for the past 6 months if taking medications or supplements for elevated lipids, blood pressure, glucose management, mood, pain, or insomnia
* Consume 1 or less servings of pulses per week
* Able to read and understand English
* Willing to comply with the protocol requirements
* Willing to provide informed consent.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Body weight =135 kg (since this exceeds the capability for Dual Energy X-ray Absorptiometry, i.e, DEXA scanning to assess body composition)
* Established cardiovascular, liver, or kidney disease
* Uncontrolled diabetes (hemoglobin HbA1c >8)
* A score of =23 on the Mini Mental State Examination
* Use of appetite suppressants or Orlistat (Xenical)
* Inability to consume pulse-enriched foods (i.e., beans, peas, chickpeas, and lentils) due to allergies or severe gastrointestinal reactions
* Pregnancy
* Smoking or only recently quit smoking (smoked any cigarettes within the last 12 months)
* Weight loss of =3kg of body weight within the 6 months prior to enrolling in the study
* Adherence to a weight loss diet or physical activity program designed to facilitate weight loss
* Acute or terminal illness.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of South Australia, Nutritional Psysiology Research Centre, Sansom Institute for Health - Adelaide
Recruitment postcode(s) [1] 0 0
5001 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Manitoba

Funding & Sponsors
Primary sponsor type
Other
Name
University of Manitoba
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of South Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Peter Zahradka, PhD
Address 0 0
University of Manitoba
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01495832