Clinical trial NCT01562171: Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk
Official title: Lentils as a Functional Food to Improve Glucose Tolerance and Decrease Cardiovascular Disease Risk in Hypercholesterolemic Overweight Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypercholesterolemia
Keywords: Overweight
Obese
Obesity
Cholesterol
Hypercholesterolemia
LDL-Cholesterol
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Glycemic Index Laboratories, Inc
name: Agriculture and Agri-Food Canada
name: Saskatchewan Pulse Growers
First posted: 2012-03-23
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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.

Primary outcomes:
measure: To examine the effect of lentils on glucose tolerance and LDL-cholesterol.
timeFrame: 12 weeks
Secondary outcomes:
measure: To examine the effect of lentils on glycated hemoglobin; fasting plasma glucose, insulin, triglycerides, HDL-cholesterol and C-reactive protein.
timeFrame: 12 weeks
Other outcomes:
measure: To examine the effect of lentils on vascular responsiveness, and biomarkers of vascular function, inflammation and metabolism.
timeFrame: 12 Weeks
Locations:
city: Winnipeg
country: Canada
facility: I.H. Asper Clinical Research Institute
state: Manitoba
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Incorporated
state: Ontario
Study officials:
affiliation: University of Manitoba
name: Carla Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Calkin 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.
citation: Juvenile diabetes Research Foundation (2005) http://www.jdrf.org.au/publications/factsheets/complications.html Accessed July 30, 2009.
citation: 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.
citation: Statistics Canada: http://www.hc-sc.gc.ca/dc-ma/diabete/index_e.html. Accessed July 30, 2009.
citation: 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.
citation: Lasker 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.
citation: Kreisberg RA. Diabetic dyslipidemia. Am J Cardiol. 1998 Dec 17;82(12A):67U-73U; discussion 85U-86U. doi: 10.1016/s0002-9149(98)00848-0.
citation: Wolever 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.
citation: Sievenpiper 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.
citation: Pulse Canada: http://www.pulsecanada.com/uploads/9f/96/9f9658890a7180395b648f83f26978c5/09-Apr-20-Clinical-Trial-release.pdf Accessed July 30, 2009.
citation: 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.
citation: Wylie-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.
citation: Delzenne 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.
citation: Anderson 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.
citation: Frick M, Weidinger F. Endothelial function: a surrogate endpoint in cardiovascular studies? Curr Pharm Des. 2007;13(17):1741-50. doi: 10.2174/138161207780831211.
citation: Tsuda T, Ueno Y, Aoki H, Koda T, Horio F, Takahashi N, Kawada T, Osawa T. Anthocyanin enhances adipocytokine secretion and adipocyte-specific gene expression in isolated rat adipocytes. Biochem Biophys Res Commun. 2004 Mar 26;316(1):149-57. doi: 10.1016/j.bbrc.2004.02.031.
citation: Hooper L, Kroon PA, Rimm EB, Cohn JS, Harvey I, Le Cornu KA, Ryder JJ, Hall WL, Cassidy A. Flavonoids, flavonoid-rich foods, and cardiovascular risk: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2008 Jul;88(1):38-50. doi: 10.1093/ajcn/88.1.38.
citation: 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. doi: 10.1152/ajpendo.2001.281.5.E924.
citation: Abdul-Ghani MA, Matsuda M, Balas B, DeFronzo RA. Muscle and liver insulin resistance indexes derived from the oral glucose tolerance test. Diabetes Care. 2007 Jan;30(1):89-94. doi: 10.2337/dc06-1519.
citation: Phillips DI, Clark PM, Hales CN, Osmond C. Understanding oral glucose tolerance: comparison of glucose or insulin measurements during the oral glucose tolerance test with specific measurements of insulin resistance and insulin secretion. Diabet Med. 1994 Apr;11(3):286-92. doi: 10.1111/j.1464-5491.1994.tb00273.x.
citation: 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. doi: 10.1161/CIRCULATIONAHA.106.176158. Epub 2006 Jun 19.
citation: Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.