Status:
COMPLETED
Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
University of South Australia
Conditions:
Obesity
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
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 performa...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01495832
Start Date
June 1 2012
End Date
June 1 2014
Last Update
September 25 2014
Active Locations (2)
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1
University of South Australia, Nutritional Psysiology Research Centre, Sansom Institute for Health
Adelaide, South Australia, Australia, 5001
2
St. Boniface Hospital Research Centre
Winnipeg, Manitoba, Canada, R2H 2A6