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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
  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: Cooked Lentils
Other: 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: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Completed
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
University of Manitoba
Glycemic Index Laboratories, Inc
Agriculture and Agri-Food Canada
Saskatchewan Pulse Growers
Investigators
Principal Investigator: Carla Taylor, PhD University of Manitoba
  More Information

Additional Information:
Publications:
Festa A, Williams K, D'Agostino R, Wagenknecht LE & Haffner SM. (2006) Diabetes 55: 1114-1120.
The Diabetes Control and Complications Trial Research Group. (1993) N Engl J Med. 329: 977-986.
Hooper L, Kroon PA, Rimm EB et al. (2008) Am J Clin Nutr 88: 38-50.
American Heart Association Nutrition Committee, Lichtenstein AH, Appel LJ, Brands M et al. (2006). Circulation 114: 82-96.

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: May 13, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 20, 2014