Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk

Obesity Clinical Trial

— LEN-0-2012  

Official title:

Lentils as a Functional Food to Improve Glucose Tolerance and Decrease Cardiovascular Disease Risk in Hypercholesterolemic Overweight Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562171
• Other study ID #: B2012:010
• Status: Completed
• Phase: N/A
• First received: March 21, 2012
• Last updated: December 11, 2014
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypercholesterolemia
• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Incorporated	Toronto	Ontario
Canada	I.H. Asper Clinical Research Institute	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
University of Manitoba	Agriculture and Agri-Food Canada, Glycemic Index Laboratories, Inc, Saskatchewan Pulse Growers

Country where clinical trial is conducted

Canada, 

References & Publications (22)

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American Heart Association Nutrition Committee, Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation. 2006 Jul 4;114(1):82-96. Epub 2006 Jun 19. Erratum in: Circulation. 2006 Dec 5;114(23):e629. Circulation. 2006 Jul 4;114(1):e27. — View Citation

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Pulse Canada: http://www.pulsecanada.com/uploads/9f/96/9f9658890a7180395b648f83f26978c5/09-Apr-20-Clinical-Trial-release.pdf Accessed July 30, 2009.

Risso A, Mercuri F, Quagliaro L, Damante G, Ceriello A. Intermittent high glucose enhances apoptosis in human umbilical vein endothelial cells in culture. Am J Physiol Endocrinol Metab. 2001 Nov;281(5):E924-30. — View Citation

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Wylie-Rosett J, Segal-Isaacson CJ & Segal-Isaacson A (2004) Obes Res 12: 124S-129S.

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To examine the effect of lentils on vascular responsiveness, and biomarkers of vascular function, inflammation and metabolism.		12 Weeks	No
Primary	To examine the effect of lentils on glucose tolerance and LDL-cholesterol.		12 weeks	No
Secondary	To examine the effect of lentils on glycated hemoglobin; fasting plasma glucose, insulin, triglycerides, HDL-cholesterol and C-reactive protein.		12 weeks	No

External Links

•   Canadian Centre for Agri-Food Research in Health & Medicine (website)