Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults
NCT ID: NCT01495832
Last Updated: 2014-09-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
150 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-06-30
Study Completion Date
2014-06-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Blinding Strategy
NONE
Study Groups
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Pulse Group
The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.
Group Type
EXPERIMENTAL
Pulse Group
Intervention Type
OTHER
The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.
Control Group
The control group will consume comparator foods for 12 weeks.
Group Type
ACTIVE_COMPARATOR
Control Group
Intervention Type
OTHER
The control group will consume comparator foods for 12 weeks.
Interventions
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Pulse Group
The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.
Intervention Type
OTHER
Control Group
The control group will consume comparator foods for 12 weeks.
Intervention Type
OTHER
Other Intervention Names
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Sanitarium
Heinz
Simplot
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
50 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of South Australia
OTHER
Sponsor Role
collaborator
University of Manitoba
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Peter Zahradka
Professor, Department of Physiology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Peter Zahradka, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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University of South Australia, Nutritional Psysiology Research Centre, Sansom Institute for Health
Adelaide, South Australia, Australia
Site Status
St. Boniface Hospital Research Centre
Winnipeg, Manitoba, Canada
Site Status
Countries
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Australia
Canada
References
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Related Links
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http://www.bing.com/search?q=st.+boniface+general+hospital+research+centre&form=DLCMHP&mkt=en-ca&qs=AS&sk=AS1&pq=st.+boniface+general+hospital&sp=2&sc=3-29
St. Boniface General Hospital Research Centre
http://www4.agr.gc.ca/AAFC-AAC/display-afficher.do?id=1262627380265&lang=eng
Canadian Centre for Agri-food Research in Health \& Medicine
Other Identifiers
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B2001:084
Identifier Type: -
Identifier Source: org_study_id
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