Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk (LEN-0-2012)
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| ClinicalTrials.gov Identifier: NCT01562171 |
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Recruitment Status :
Completed
First Posted : March 23, 2012
Last Update Posted : December 12, 2014
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Sponsor:
University of Manitoba
Collaborators:
Glycemic Index Laboratories, Inc
Agriculture and Agri-Food Canada
Saskatchewan Pulse Growers
Information provided by (Responsible Party):
Dr. Carla Taylor, University of Manitoba
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity Hypercholesterolemia | Other: Cooked Lentils Other: Potato-Based Foods | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Official Title: | Lentils as a Functional Food to Improve Glucose Tolerance and Decrease Cardiovascular Disease Risk in Hypercholesterolemic Overweight Individuals |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | September 2014 |
| Actual Study Completion Date : | September 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
Primary Outcome Measures :
- To examine the effect of lentils on glucose tolerance and LDL-cholesterol. [ Time Frame: 12 weeks ]
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 ]
Other Outcome Measures:
- To examine the effect of lentils on vascular responsiveness, and biomarkers of vascular function, inflammation and metabolism. [ Time Frame: 12 Weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562171
Locations
| Canada, Manitoba | |
| I.H. Asper Clinical Research Institute | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Ontario | |
| Glycemic Index Laboratories, Incorporated | |
| 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 |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Juvenile diabetes Research Foundation (2005) http://www.jdrf.org.au/publications/factsheets/complications.html Accessed July 30, 2009.
Statistics Canada: http://www.hc-sc.gc.ca/dc-ma/diabete/index_e.html. Accessed July 30, 2009.
Pulse Canada: http://www.pulsecanada.com/uploads/9f/96/9f9658890a7180395b648f83f26978c5/09-Apr-20-Clinical-Trial-release.pdf Accessed July 30, 2009.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Carla Taylor, Professor, Department of Human Nutritional Sciences, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT01562171 |
| Other Study ID Numbers: |
B2012:010 |
| First Posted: | March 23, 2012 Key Record Dates |
| Last Update Posted: | December 12, 2014 |
| Last Verified: | December 2014 |
Keywords provided by Dr. Carla Taylor, University of Manitoba:
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Overweight Obese Obesity |
Cholesterol Hypercholesterolemia LDL-Cholesterol |
Additional relevant MeSH terms:
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Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |