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ObesityPULSA-2011NCT01495832

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

A study testing Pulse Group in people with Obesity, run by University of Manitoba at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 performance which can impact adversely on the ability to undertake daily activities and increases the risk of loss of… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Obesity
What is being tested?
Pulse Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesin 2 countries
Study dates
Jun 2012to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Australia1 site

  • University of South Australia, Nutritional Psysiology Research Centre, Sansom Institute for Health

    Adelaide, South Australia, 5001

Other trials in Australia

Canada1 site

  • St. Boniface Hospital Research Centre

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Obesity
Being tested
Pulse Group, Control Group
Keywords
Adult Obesity, Cardiometabolic health, Pulse Foods, Beans, Peas, Lentils, Cognitive Function
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulse GroupOther

    Also called Sanitarium, Heinz, Simplot

    The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.

  • Control GroupOther

    The control group will consume comparator foods for 12 weeks.

Study groups in NCT01495832
Study groupRoleWhat they receive
Pulse GroupExperimentalThe pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.
Receives: Other: Pulse Group
Control GroupActive comparatorThe control group will consume comparator foods for 12 weeks.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vascular Function

    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.

    Measured: 12 weeks

  2. Cerebral Blood Flow Velocity (Australian Site only)

    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.

    Measured: 12 Weeks

Secondary outcomes (1)

  1. Cognitive Function

    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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2011 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01495832
Sponsor's protocol ID
B2001:084
Acronym
PULSA-2011
Status last verified
Sep 2014
First submitted
16 Dec 2011
Last updated
25 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Katzmarzyk PT. The Canadian obesity epidemic, 1985-1998. CMAJ. 2002 Apr 16;166(8):1039-40. No abstract available.

    PubMed 12002980

  • Raine K. Overweight and obesity in Canada: a population health perspective. Alberta: Centre for Health Promotion Studies, University of Alberta, 2004.

  • Cameron AJ, Welborn TA, Zimmet PZ, Dunstan DW, Owen N, Salmon J, Dalton M, Jolley D, Shaw JE. Overweight and obesity in Australia: the 1999-2000 Australian Diabetes, Obesity and Lifestyle Study (AusDiab). Med J Aust. 2003 May 5;178(9):427-32. doi: 10.5694/j.1326-5377.2004.tb05998.x.

    PubMed 12720507

  • 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.

  • Poirier P, Giles TD, Bray GA, Hong Y, Stern JS, Pi-Sunyer FX, Eckel RH; American Heart Association; Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Obesity and cardiovascular disease: pathophysiology, evaluation, and effect of weight loss: an update of the 1997 American Heart Association Scientific Statement on Obesity and Heart Disease from the Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2006 Feb 14;113(6):898-918. doi: 10.1161/CIRCULATIONAHA.106.171016. Epub 2005 Dec 27.

    PubMed 16380542

  • Elias MF, Elias PK, Sullivan LM, Wolf PA, D'Agostino RB. Lower cognitive function in the presence of obesity and hypertension: the Framingham heart study. Int J Obes Relat Metab Disord. 2003 Feb;27(2):260-8. doi: 10.1038/sj.ijo.802225.

    PubMed 12587008

  • Elias MF, Elias PK, Sullivan LM, Wolf PA, D'Agostino RB. Obesity, diabetes and cognitive deficit: The Framingham Heart Study. Neurobiol Aging. 2005 Dec;26 Suppl 1:11-6. doi: 10.1016/j.neurobiolaging.2005.08.019. Epub 2005 Oct 11.

    PubMed 16223549

  • Kilander L, Nyman H, Boberg M, Lithell H. Cognitive function, vascular risk factors and education. A cross-sectional study based on a cohort of 70-year-old men. J Intern Med. 1997 Oct;242(4):313-21. doi: 10.1046/j.1365-2796.1997.00196.x.

    PubMed 9366810

  • Sorensen TI, Sonne-Holm S, Christensen U, Kreiner S. Reduced intellectual performance in extreme overweight. Hum Biol. 1982 Dec;54(4):765-75. No abstract available.

    PubMed 7166298

  • 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.

  • Lakatta EG, Levy D. Arterial and cardiac aging: major shareholders in cardiovascular disease enterprises: Part II: the aging heart in health: links to heart disease. Circulation. 2003 Jan 21;107(2):346-54. doi: 10.1161/01.cir.0000048893.62841.f7. No abstract available.

    PubMed 12538439

  • Versari D, Daghini E, Virdis A, Ghiadoni L, Taddei S. The ageing endothelium, cardiovascular risk and disease in man. Exp Physiol. 2009 Mar;94(3):317-21. doi: 10.1113/expphysiol.2008.043356. Epub 2008 Sep 19.

    PubMed 18805864

  • Guidelines for the evaluation of dementia and age-related cognitive decline. American Psychological Association Presidential Task Force. Am Psychol. 1998 Dec;53(12):1298-303.

    PubMed 9872051

Questions about this trial

What is this clinical trial studying?

A study testing Pulse Group in people with Obesity, run by University of Manitoba at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular Function (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01495832, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.

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