Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk (LEN-0-2012)
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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 |
- 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 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 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 |
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| Contact: Carla Taylor, PhD | 204-258-1361 | Carla.Taylor@ad.umanitoba.ca |
| Contact: Peter Zahradka, PhD | 204-235-3507 | pzahradka@sbrc.ca |
| 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 | |
| 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 23, 2013