Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk (LEN-0-2012)

This study is currently recruiting participants.
Verified October 2012 by University of Manitoba
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Dr. Carla Taylor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01562171
First received: March 21, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with high cholesterol and obesity.


Condition Intervention
Obesity
Hypercholesterolemia
Other: Consumption of cooked lentils
Other: Consumption of potato-based foods

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Lentils as a Functional Food to Improve Glucose Tolerance and Decrease Cardiovascular Disease Risk in Hypercholesterolemic Overweight Individuals

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • To examine the effect of lentils on glucose tolerance and LDL-cholesterol. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effect of lentils on glycated hemoglobin; fasting plasma glucose, insulin, triglycerides, HDL-cholesterol and C-reactive protein. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To examine the effect of lentils on vascular responsiveness, and biomarkers of vascular function, inflammation and metabolism. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Consumption of cooked lentils Other: Consumption of cooked lentils
Consumption of food items containing one serving of (0.3 cups) of cooked lentils per day for the first 5 days, followed by one serving of (0.6 cups) of cooked lentils per day 5 times per week (equivalent of 3 cups cooked lentils per week) for the remainder of the 12-week schedule. The foods will be incorporated into the participant's normal dietary pattern.
Active Comparator: Consumption of potato-based foods Other: Consumption of potato-based foods
Consumption one serving per day of potato-based foods in matrices similar to those containing lentils in the same 12-week schedule, including the smaller serving size for the first 5 days. The foods will be incorporated into the participant's normal dietary pattern.

Detailed Description:

This is a multi-site, randomized, controlled, parallel group food study designed to examine the health benefits, specifically glucose tolerance, insulin sensitivity and LDL-cholesterol in overweight individuals with a high waist circumference and elevated LDL-cholesterol. Recruitment will consist of approximately 102 overweight participants (n= 51 participants per site, at 2 sites located in Winnipeg and Toronto) with high waist circumference and elevated LDL-cholesterol.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-lactating females aged 30 to 75 years;
  • Body Mass Index of ≤40 kg/m2 and ≥23 kg/m2 if Asian or ≥25 kg/m2 if non-Asian;
  • Waist circumference ≥94 cm for males and ≥80 cm for females of Asian ethnicity,and ≥102 cm for males and ≥88 cm of non-Asian ethnicity;
  • Fasting plasma glucose <7 mmol/L;
  • Fasting triglycerides <4.00 mmol/L and LDL-cholesterol >2.50 mmol/L and <5.00 mmol/L;
  • Must be on a stable regime for the past 3 months if taking medications to treat hypertension or if taking vitamin and mineral/dietary/herbal supplements;
  • Stable body weight (±3 kg) for the past 3 months

Exclusion Criteria:

  • Previous diagnosis of type 2 diabetes;
  • High pulse consumption (≥2 servings per week);
  • Presence of liver disease (aspartate transaminase >2 times Upper Normal Limit), renal insufficiency (creatinine >1.5 times Upper Normal Limit); inflammatory bowel disease or other gastrointestinal disorders influencing gastrointestinal motility or nutrient absorption;
  • Use of medication which influence carbohydrate metabolism (i.e., steroids), or medications used to treat diabetes or to lower blood lipids, or any active medical or surgical conditions within the past 3 months;
  • Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results;
  • History of gastrointestinal reactions or allergies to lentils or potato-based foods, or to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562171

Contacts
Contact: Carla Taylor, PhD 204-258-1361 Carla.Taylor@ad.umanitoba.ca
Contact: Peter Zahradka, PhD 204-235-3507 pzahradka@sbrc.ca

Locations
Canada, Manitoba
I.H. Asper Clinical Research Institute Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Carla Taylor, PhD     204-258-1361     Carla.Taylor@ad.umanitoba.ca    
Principal Investigator: Carla Taylor, PhD            
Canada, Ontario
Glycemic Index Laboratories, Incorporated Recruiting
Toronto, Ontario, Canada, M5C 2N8
Contact: Thomas Wolever, PhD, DM            
Sub-Investigator: Thomas Wolever, PhD DM            
Sponsors and Collaborators
University of Manitoba
Agriculture and Agri-Food Canada
Investigators
Principal Investigator: Carla Taylor, PhD University of Manitoba
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Carla Taylor, Professor, Department of Human Nutritional Sciences, University of Manitoba
ClinicalTrials.gov Identifier: NCT01562171     History of Changes
Other Study ID Numbers: B2012:010
Study First Received: March 21, 2012
Last Updated: October 10, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Overweight
Obese
Obesity
Cholesterol
Hypercholesterolemia
LDL-Cholesterol

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Obesity
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013