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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Manitoba
Sponsor:
Collaborators:
Glycemic Index Laboratories, Inc
Agriculture and Agri-Food Canada
Saskatchewan Pulse Growers
Information provided by (Responsible Party):
Dr. Carla Taylor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01562171
First received: March 21, 2012
Last updated: May 13, 2014
Last verified: May 2014

March 21, 2012
May 13, 2014
March 2012
August 2014   (final data collection date for primary outcome measure)
To examine the effect of lentils on glucose tolerance and LDL-cholesterol. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To examine the effect of lentils on glucose tolerance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01562171 on ClinicalTrials.gov Archive Site
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 ]
To examine the effects of lentils on LDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ]
Not Provided
 
Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk
Lentils as a Functional Food to Improve Glucose Tolerance and Decrease Cardiovascular Disease Risk in Hypercholesterolemic Overweight Individuals

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Obesity
  • Hypercholesterolemia
  • Other: Cooked Lentils
    Consume 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.
  • Other: Potato-Based Foods
    Control - Consumption of 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.
  • Experimental: Cooked Lentils
    The study group will be asked to consume 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.
    Intervention: Other: Cooked Lentils
  • Active Comparator: Potato-Based Foods
    The control group will be asked to consume 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.
    Intervention: Other: Potato-Based Foods

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
102
September 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
30 Years to 75 Years
No
Contact: Carla Taylor, PhD 204-258-1361 Carla.Taylor@ad.umanitoba.ca
Contact: Peter Zahradka, PhD 204-235-3507 pzahradka@sbrc.ca
Canada
 
NCT01562171
B2012:010
No
Dr. Carla Taylor, University of Manitoba
University of Manitoba
  • Glycemic Index Laboratories, Inc
  • Agriculture and Agri-Food Canada
  • Saskatchewan Pulse Growers
Principal Investigator: Carla Taylor, PhD University of Manitoba
University of Manitoba
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP