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Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults (PULSA-2011)

This study has been completed.
University of South Australia
Information provided by (Responsible Party):
Dr. Peter Zahradka, University of Manitoba Identifier:
First received: December 16, 2011
Last updated: September 24, 2014
Last verified: September 2014
The Canadian population, as is the case in most developed countries, is ageing and becoming increasingly overweight and/or obese. Both ageing and obesity are associated with reduced cognitive performance which can impact adversely on the ability to undertake daily activities and increases the risk of loss of independent living and reduced quality of life. The investigators predict that consumption of ½ cup of pulses per day for 12 weeks will improve cognitive function in older overweight/obese adults and thus decrease the rate of cognitive decline that occurs in this at-risk population.

Condition Intervention
Other: Pulse Group
Other: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Vascular Function [ Time Frame: 12 weeks ]
    Vascular function will be assessed non-invasively (at baseline, Week 6, and Week 12) with measurement of arterial compliance (elasticity) by pulse wave analysis and pulse wave velocity. Measurement of arterial vasodilation will be done non-invasively to evaluate endothelial cells which line the blood vessels that regulate blood flow. Blood samples will be taken to assess markers of vascular function.

  • Cerebral Blood Flow Velocity (Australian Site only) [ Time Frame: 12 Weeks ]
    Cerebral blood flow velocity will be assessed (baseline , Week 6, Week 12) by transcranial Doppler ultrasonography. This will serve as an index of arterial vasodilator responsiveness in the cerebral circulation. This will be performed by the Australian site only.

Secondary Outcome Measures:
  • Cognitive Function [ Time Frame: 12 weeks ]
    A selection of cognitive tests will be administered (baseline, Week 6, and Week 12) by a qualified member of the study team to assess varying aspects of the participant's level of functioning cognition.

Enrollment: 150
Study Start Date: June 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulse Group
The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.
Other: Pulse Group
The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.
Other Names:
  • Sanitarium
  • Heinz
  • Simplot
Active Comparator: Control Group
The control group will consume comparator foods for 12 weeks.
Other: Control Group
The control group will consume comparator foods for 12 weeks.

Detailed Description:

This is a multi-site, randomized, controlled, parallel, dietary intervention food study designed to examine the impact of pulse-enriched foods on cognitive function and cardiometabolic health in obese adults. Recruitment will consist of approximately 160 participants (n= 80 participants per site) at 2 sites located in Winnipeg and South Australia.

Participants will be randomly allocated to one of 2 groups; a pulse group or a control group. The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks. The control group will consume comparator foods for 12 weeks. The pulse and comparator food items will be provided to participants and they will be asked to incorporate these into their usual diet. Participants will be requested not to change their diet or physical activity habits during the study period, other than as required to comply with the study requirements. Five-day weighed food records will be completed during the week prior to baseline and during the final week of the study to monitor dietary intake, in particular intake of pulses. This will determine whether participants are incorporating the study foods as required, and will be used to evaluate associated changes in dietary intake and body weight, if they occur.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01495832

Australia, South Australia
University of South Australia, Nutritional Psysiology Research Centre, Sansom Institute for Health
Adelaide, South Australia, Australia, 5001
Canada, Manitoba
St. Boniface Hospital Research Centre
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
University of South Australia
Principal Investigator: Peter Zahradka, PhD University of Manitoba
  More Information

Additional Information:
Raine K. Overweight and obesity in Canada: a population health perspective. Alberta: Centre for Health Promotion Studies, University of Alberta, 2004.
Tjepkema M. Adult obesity in Canada: measured height and weight. Nutrition: Findings from the Canadian Community Health Survey. Ottawa, 2005.
Australian Bureau of Statistics. National Health Survey 2007-2008. In: Australian Institute of Health and Welfare, ed. Canberra: Commonwealth of Australia, 2009.
Health Canada and Interdepartmental Committee on Aging and Seniors Issues. Canada's Aging Population. In: Minister of Public Works and Government Services, ed.: Health Canada, 2002.
Australian Bureau of Statistics. Population projections Australia 2001-2101. Canberra: Commonwealth of Australia, 2003.
Zahradka, P., Guzman, R., Weighell, W., Wright, B., Baldwin, A., Louis, S., Rodriguez, D., and Taylor, C.G. 2009 Increased consumption of legumes improves arterial stiffness in peripheral vascular disease independent of blood pressure, weight and serum cholesterol. Experimental Biology 2009, April 18-22, New Orleans, LA. [oral presentation].

Responsible Party: Dr. Peter Zahradka, Professor, Department of Physiology, University of Manitoba Identifier: NCT01495832     History of Changes
Other Study ID Numbers: B2001:084
Study First Received: December 16, 2011
Last Updated: September 24, 2014

Keywords provided by University of Manitoba:
Adult Obesity
Cardiometabolic health
Pulse Foods
Beans, Peas, Lentils
Cognitive Function processed this record on April 26, 2017