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

This study has been completed.
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: September 24, 2014
Last verified: September 2014

December 16, 2011
September 24, 2014
June 2012
June 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01495832 on ClinicalTrials.gov Archive Site
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.
  • Cerebral blood flow velocity [ 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.
  • 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.
Not Provided
Not Provided
 
Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults
Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Obesity
  • 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
  • Other: Control Group
    The control group will consume comparator foods for 12 weeks.
  • Experimental: Pulse Group
    The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.
    Intervention: Other: Pulse Group
  • Active Comparator: Control Group
    The control group will consume comparator foods for 12 weeks.
    Intervention: Other: Control Group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Australia
 
NCT01495832
B2001:084
No
Dr. Peter Zahradka, University of Manitoba
University of Manitoba
University of South Australia
Principal Investigator: Peter Zahradka, PhD University of Manitoba
University of Manitoba
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP