U of A/ U of M Beans and Peas Health Claim Project
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare how regularly eating (dried) beans or peas or rice
      (control) lowers blood lipids, particularly Low Density Lipoprotein cholesterol and total
      cholesterol, in mildly hypercholesterolemic men and women. The investigators hypothesize that
      regularly eating beans or peas will significantly improve blood lipid profiles in these
      people.

      Participants in this study will consume 1 study food item 5 out of 7 days a week containing
      beans or peas or rice for a total of 6 weeks. This study will benefit Canadian pulse growers
      by enhancing development of food products for human consumption and supporting marketing
      strategies to increase awareness that a diet rich in pulses can improve human health.
      Measuring changes in blood and urinary polyphenol levels will help to verify whether these
      compounds play a role in the beneficial actions of beans and peas and subsequently assist
      with the identification of the beneficial bean/pea components. This in turn, will enable crop
      breeders to select for plants that are rich in these compounds.
    

Detailed description: 
      OBJECTIVES: The aim of this study is to conduct a multi-centre randomized, controlled trial
      to specifically compare the biological effectiveness of bean versus peas vs rice (control) on
      LDL-cholesterol in mildly hypercholesterolemic men and women. In addition, the effects of
      beans and peas on other key factors associated with cardiovascular disease, including
      triglycerides, High Density Lipoprotein-cholesterol, body weight/fatness, glucose, insulin,
      glycated hemoglobin and biomarkers of vascular function. Inflammation and metabolism will be
      investigated, as well as the participants' assessment of study food acceptability, satiety
      and gastrointestinal responses.

      BACKGROUND: Pulses (beans, peas, lentils and chickpeas) are healthy foods that contain twice
      the amount of protein as cereals, are very high in fibre, key vitamins and minerals like
      folate and iron and are low in fat. Canada is the world's largest producer and exporter of
      lentils and peas, and Alberta produced 34% of the pea crop and 12% of beans in 2010. Current
      consumption of pulses in Canada is low, due to a lack of pulse-based convenient food
      products. An approved health claim can drive interest in development of food products with
      particular ingredients as seen with oat beta-glucan. Experts agree that existing evidence for
      the cholesterol-lowering effects of pulses is particularly strong for beans, but more studies
      are needed to show the effects of peas, lentils and chickpeas are comparable to beans.
      Results from this study will be used to substantiate a health claim for beans and other pulse
      crops in the future, similar to the health claims that exist for beta-glucan and plant
      sterols.

      METHODS AND PROCEDURES: This multi-center study will compare the effects of beans (pinto,
      black, Great Northern, small red) versus peas (yellow, green) to control (rice-based) foods
      on total and Low Density Lipoprotein-Cholesterol in mildly hypercholesterolemic (>3 mmol/L
      and < 5mmol/L; not on medications) adults. There will be 3 study arms: i) beans, ii) peas,
      and iii) rice (control). The study groups will be asked to consume food items containing 120
      grams of cooked beans or cooked peas daily for 6 weeks. The control group will be asked to
      consume one 1/2 cup serving per day of rice-based foods in matrices similar to those
      containing beans or peas for 6 weeks. The study or control foods will be incorporated into
      the participants normal dietary pattern. All food items will be provided to participants free
      of charge. Food items, generally in the form of soups or stews, will be developed by a
      collaborator in Food Science at the University of Manitoba in the initial phase of this
      project .

      The investigators plan to recruit approximately 180 participants (n= 75 participants at the
      University of Manitoba and n= 105 at University of Alberta). Interested individuals
      (potential participants) will be first asked to attend a screening visit. The screening visit
      procedures will be discussed prior to the screening visit, including the need to fast (i.e.,
      no food or beverage intake except water for 12 hours) for blood sampling to determine if
      Low-density-lipoprotein-cholesterol and triglyceride levels are within acceptable range. Once
      at this visit, individuals will be provided with a description of the study by the
      investigating team's study coordinator. The eligibility criteria will be reviewed with
      candidates by the investigating team's study coordinator to assess their suitability for the
      study. Individuals meeting all inclusion/exclusion criteria will be contacted by the study
      coordinator with this information. All individuals who are screened will be contacted by the
      study coordinator once eligibility has been confirmed. An appointment for a baseline
      assessment meeting will be scheduled for those who are eligible and who confirm interest in
      the study; those who are not eligible or who are eligible and no longer wish to participate
      will be thanked for their time.

      At the baseline assessment visit individuals will be reminded of the study description and
      will be asked to provide written informed consent at this time.

      Once enrolled, participants will undergo a complete medical history including age, sex,
      alcohol use, exercise habits, current medical problems, medication and family history of
      previous events such as stroke and diabetes. A fasting blood sample will be obtained to
      assess plasma lipid profile.

      Participants will be asked to attend 4 in-person clinic visits over the duration of the study
      for screening, baseline assessment, and at 3 and 6 weeks (at the end of the study).

      Once identified and after giving informed consent, participants will be randomized to one of
      the 3 study arms. The randomization will be either computer generated, or done manually by a
      study coordinator for both sites. Each participant will be given a randomized number, and
      will be used for all study documentation.

      Participants will fill out questionnaire relating to demographics, lifestyle, food intake,
      gastrointestinal responses etc.

      The baseline visit will include a height and weight measurement, waist circumference and body
      composition using the Bod Pod machine (air displacement) Blood pressure will be recorded.
      Participants will be assessed for changes in their medication profile and discuss current
      medical conditions. The three day food record (completed at home) will be collected. Urine
      sample and fasting blood sample will be drawn for lipid assessment profile, insulin, glucose,
      glycated hemoglobin, polyphenols and biomarkers of vascular function, inflammation and
      metabolism. Blood required will not exceed 60mL.

      Randomization will be done at the baseline visit. Prior to leaving, participants will be
      provided with the first 3-week supply of assigned foods and instruction about how to prepare
      and consume them, and will be reminded to fast before their next visit. This visit will take
      approximately 2.5 hours.

      Week 3 visit will include height and weight measurements, waist circumference and body
      composition using Bod Pod (via air displacement). Blood pressure will be recorded.
      Participants will be assessed for changes in their medication profile and current medical
      conditions. The 3 day food record (completed at home) will be collected. Urine sample will be
      collected. Fasting blood sample will be drawn for assessment of lipid profile, insulin,
      glucose, glycated hemoglobin, polyphenols and biomarkers of vascular function, inflammation
      and metabolism. The total blood required will not exceed 60mL.

      Participants will complete a questionnaire to assess compliance, acceptability of the study
      foods, satiety, GI responses and any adverse events. Questions will be addressed. Before
      leaving, participants will be provided with the second 3-week supply of assigned foods, and
      instructions about how to prepare and consume them. Participants will be reminded to fast
      prior to next visit. Visit will take approximately 2 hours.

      Week 6 visit: Measurements taken for height and weight, waist circumference, body composition
      using Bod Pod (air displacement) and blood pressure will be repeated. Participants will be
      assessed for changes in their medication profile and current medical conditions. Urine sample
      will be collected for polyphenols. A fasting blood sample will be drawn for assessment of
      lipid profile, insulin, glucose, glycated hemoglobin, polyphenols, and biomarkers of vascular
      function (University of Manitoba only), inflammation and metabolism. Total blood will not
      exceed 60 mL. Participants will complete a questionnaire to assess compliance, acceptability
      of the foods, satiety, Gastrointestinal responses and any adverse events. Total time
      required, approximately 2.5 hours. Completion of this visit marks the end of the study.
      Participants will be paid, and thanked for their time.
    

Intervention name(s): Beans; Control (rice); Peas
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 90g of beans per day for 5 out of 7 days per week will be given to participants for 6 weeks to determine the cholesterol lowering effects of various pulses.; 90g of rice per day will be given to the control group to demonstrate the cholesterol lowering effects of the experimental group.; 90 grams of peas will be consumed 5 out of 7 days per week
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment