Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Manitoba
Sponsor:
Collaborator:
University of South Australia
Information provided by (Responsible Party):
Dr. Peter Zahradka, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01495832
First received: December 16, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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
Obesity
Other: Pulse Group
Other: Active Comparator

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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Vascular Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated 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: Active Comparator
The control group will consume comparator foods for 12 weeks.
Other Names:
  • Sanitarium
  • Heinz
  • Simplot

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495832

Contacts
Contact: Peter Zahradka, PhD 204-235-3507 pzahradka@sbrc.ca
Contact: Carla Taylor, PhD 204-258-1361 ctaylor@cc.umanitoba.ca

Locations
Australia, South Australia
University of South Australia, Nutritional Psysiology Research Centre, Sansom Institute for Health Completed
Adelaide, South Australia, Australia, 5001
Canada, Manitoba
St. Boniface Hospital Research Centre Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Peter Zahradka, PhD    204-235-3507    pzahradka@sbrc.ca   
Contact: Carla Taylor, PhD    204-258-1361    ctaylor@cc.umanitoba.ca   
Sub-Investigator: Randy Guzman, MD         
Sponsors and Collaborators
University of Manitoba
University of South Australia
Investigators
Principal Investigator: Peter Zahradka, PhD University of Manitoba
  More Information

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT01495832     History of Changes
Other Study ID Numbers: PULSA-0-2011
Study First Received: December 16, 2011
Last Updated: February 11, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Manitoba:
Adult Obesity
Cardiometabolic health
Pulse Foods
Beans, Peas, Lentils
Cognitive Function

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014