ObesityLEN-0-2012NCT01562171
Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk
A study testing Cooked Lentils and Potato-Based Foods in people with Obesity and Hypercholesterolemia, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Obesity, Hypercholesterolemia
- What is being tested?
- Cooked Lentils and Potato-Based Foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Glycemic Index Laboratories, Incorporated
Toronto, Ontario, M5C 2N8
I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Hypercholesterolemia
- Being tested
- Cooked Lentils, Potato-Based Foods
- Keywords
- Overweight, Obese, Obesity, Cholesterol, Hypercholesterolemia, LDL-Cholesterol
- Medical subject headings
- Obesity, Hypercholesterolemia, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooked LentilsOther
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.
Potato-Based FoodsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cooked Lentils | Experimental | 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. Receives: Other: Cooked Lentils |
| Potato-Based Foods | Active comparator | 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. Receives: Other: Potato-Based Foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect of lentils on glucose tolerance and LDL-cholesterol.
Measured: 12 weeks
Secondary outcomes (1)
To examine the effect of lentils on glycated hemoglobin; fasting plasma glucose, insulin, triglycerides, HDL-cholesterol and C-reactive protein.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Glycemic Index Laboratories, Inc, Agriculture and Agri-Food Canada, Saskatchewan Pulse Growers
- Responsible party
- Principal investigator, Dr. Carla Taylor, University of Manitoba
- Investigators
- Carla Taylor, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562171
- Sponsor's protocol ID
- B2012:010
- Acronym
- LEN-0-2012
- Status last verified
- Dec 2014
- First submitted
- 21 Mar 2012
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilson PW, D'Agostino RB, Sullivan L, Parise H, Kannel WB. Overweight and obesity as determinants of cardiovascular risk: the Framingham experience. Arch Intern Med. 2002 Sep 9;162(16):1867-72. doi: 10.1001/archinte.162.16.1867.
PubMed 12196085Calkin AC, Allen TJ. Diabetes mellitus-associated atherosclerosis: mechanisms involved and potential for pharmacological invention. Am J Cardiovasc Drugs. 2006;6(1):15-40. doi: 10.2165/00129784-200606010-00003.
PubMed 16489846Juvenile diabetes Research Foundation (2005) http://www.jdrf.org.au/publications/factsheets/complications.html Accessed July 30, 2009.
Li TY, Rana JS, Manson JE, Willett WC, Stampfer MJ, Colditz GA, Rexrode KM, Hu FB. Obesity as compared with physical activity in predicting risk of coronary heart disease in women. Circulation. 2006 Jan 31;113(4):499-506. doi: 10.1161/CIRCULATIONAHA.105.574087.
PubMed 16449729Statistics Canada: http://www.hc-sc.gc.ca/dc-ma/diabete/index_e.html. Accessed July 30, 2009.
Festa A, Williams K, D'Agostino R Jr, Wagenknecht LE, Haffner SM. The natural course of beta-cell function in nondiabetic and diabetic individuals: the Insulin Resistance Atherosclerosis Study. Diabetes. 2006 Apr;55(4):1114-20. doi: 10.2337/diabetes.55.04.06.db05-1100.
PubMed 16567536Lasker RD. The diabetes control and complications trial. Implications for policy and practice. N Engl J Med. 1993 Sep 30;329(14):1035-6. doi: 10.1056/NEJM199309303291410. No abstract available.
PubMed 8366905Kreisberg RA. Diabetic dyslipidemia. Am J Cardiol. 1998 Dec 17;82(12A):67U-73U; discussion 85U-86U. doi: 10.1016/s0002-9149(98)00848-0.
PubMed 9915665Wolever TM, Mehling C, Chiasson JL, Josse RG, Leiter LA, Maheux P, Rabasa-Lhoret R, Rodger NW, Ryan EA. Low glycaemic index diet and disposition index in type 2 diabetes (the Canadian trial of carbohydrates in diabetes): a randomised controlled trial. Diabetologia. 2008 Sep;51(9):1607-15. doi: 10.1007/s00125-008-1093-x. Epub 2008 Jul 22.
PubMed 18648764Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
PubMed 19526214Pulse Canada: http://www.pulsecanada.com/uploads/9f/96/9f9658890a7180395b648f83f26978c5/09-Apr-20-Clinical-Trial-release.pdf Accessed July 30, 2009.
Rizkalla SW, Bellisle F, Slama G. Health benefits of low glycaemic index foods, such as pulses, in diabetic patients and healthy individuals. Br J Nutr. 2002 Dec;88 Suppl 3:S255-62. doi: 10.1079/BJN2002715.
PubMed 12498625Wylie-Rosett J, Segal-Isaacson CJ, Segal-Isaacson A. Carbohydrates and increases in obesity: does the type of carbohydrate make a difference? Obes Res. 2004 Nov;12 Suppl 2:124S-9S. doi: 10.1038/oby.2004.277.
PubMed 15601960Delzenne NM, Cani PD. A place for dietary fibre in the management of the metabolic syndrome. Curr Opin Clin Nutr Metab Care. 2005 Nov;8(6):636-40. doi: 10.1097/01.mco.0000171124.06408.71.
PubMed 16205465Anderson JW, Major AW. Pulses and lipaemia, short- and long-term effect: potential in the prevention of cardiovascular disease. Br J Nutr. 2002 Dec;88 Suppl 3:S263-71. doi: 10.1079/BJN2002716.
PubMed 12498626
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lentils as a Functional Food to Improve Glucose Tolerance and Decrease Cardiovascular Disease Risk in Hypercholesterolemic Overweight Individuals
- ClinicalTrials.gov ID
- NCT01562171
- Acronym / sponsor ID
- LEN-0-2012 / B2012:010
- Conditions
- Obesity, Hypercholesterolemia
- Keywords
- Overweight, Obese, Obesity, Cholesterol, Hypercholesterolemia, LDL-Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Glycemic Index Laboratories, Inc, Agriculture and Agri-Food Canada, Saskatchewan Pulse Growers
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooked Lentils | Experimental | Other: Cooked LentilsThe 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. |
| Potato-Based Foods | Active comparator | Other: Potato-Based FoodsThe 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooked LentilsConsume 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 |
| Potato-Based FoodsControl - 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. | Other | Potato-Based Foods |
Primary outcome
To examine the effect of lentils on glucose tolerance and LDL-cholesterol.
Time frame: 12 weeks
1 secondary outcome
To examine the effect of lentils on glycated hemoglobin; fasting plasma glucose, insulin, triglycerides, HDL-cholesterol and C-reactive protein.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- Background: PubMed 12196085Wilson PW, D'Agostino RB, Sullivan L, Parise H, Kannel WB. Overweight and obesity as determinants of cardiovascular risk: the Framingham experience. Arch Intern Med. 2002 Sep 9;162(16):1867-72. doi: 10.1001/archinte.162.16.1867.
- Background: PubMed 16489846Calkin AC, Allen TJ. Diabetes mellitus-associated atherosclerosis: mechanisms involved and potential for pharmacological invention. Am J Cardiovasc Drugs. 2006;6(1):15-40. doi: 10.2165/00129784-200606010-00003.
- BackgroundJuvenile diabetes Research Foundation (2005) http://www.jdrf.org.au/publications/factsheets/complications.html Accessed July 30, 2009.
- Background: PubMed 16449729Li TY, Rana JS, Manson JE, Willett WC, Stampfer MJ, Colditz GA, Rexrode KM, Hu FB. Obesity as compared with physical activity in predicting risk of coronary heart disease in women. Circulation. 2006 Jan 31;113(4):499-506. doi: 10.1161/CIRCULATIONAHA.105.574087.
- BackgroundStatistics Canada: http://www.hc-sc.gc.ca/dc-ma/diabete/index_e.html. Accessed July 30, 2009.
- Background: PubMed 16567536Festa A, Williams K, D'Agostino R Jr, Wagenknecht LE, Haffner SM. The natural course of beta-cell function in nondiabetic and diabetic individuals: the Insulin Resistance Atherosclerosis Study. Diabetes. 2006 Apr;55(4):1114-20. doi: 10.2337/diabetes.55.04.06.db05-1100.
- Background: PubMed 8366905Lasker RD. The diabetes control and complications trial. Implications for policy and practice. N Engl J Med. 1993 Sep 30;329(14):1035-6. doi: 10.1056/NEJM199309303291410. No abstract available.
- Background: PubMed 9915665Kreisberg RA. Diabetic dyslipidemia. Am J Cardiol. 1998 Dec 17;82(12A):67U-73U; discussion 85U-86U. doi: 10.1016/s0002-9149(98)00848-0.
- Background: PubMed 18648764Wolever TM, Mehling C, Chiasson JL, Josse RG, Leiter LA, Maheux P, Rabasa-Lhoret R, Rodger NW, Ryan EA. Low glycaemic index diet and disposition index in type 2 diabetes (the Canadian trial of carbohydrates in diabetes): a randomised controlled trial. Diabetologia. 2008 Sep;51(9):1607-15. doi: 10.1007/s00125-008-1093-x. Epub 2008 Jul 22.
- Background: PubMed 19526214Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
- BackgroundPulse Canada: http://www.pulsecanada.com/uploads/9f/96/9f9658890a7180395b648f83f26978c5/09-Apr-20-Clinical-Trial-release.pdf Accessed July 30, 2009.
- Background: PubMed 12498625Rizkalla SW, Bellisle F, Slama G. Health benefits of low glycaemic index foods, such as pulses, in diabetic patients and healthy individuals. Br J Nutr. 2002 Dec;88 Suppl 3:S255-62. doi: 10.1079/BJN2002715.
- Canadian Centre for Agri-Food Research in Health \& Medicine (website)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Taylor, PhD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooked Lentils and Potato-Based Foods in people with Obesity and Hypercholesterolemia, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the effect of lentils on glucose tolerance and LDL-cholesterol. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562171, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.