Chronic Disease Risk Factors – Inquis Clinical Research

Chronic Disease Risk Factors

Consumers are increasingly looking to food products to offer health benefits and play a role in disease prevention and management. At INQUIS Clinical Research, we have extensive experience conducting trials related to chronic disease risk factors and health outcomes. Our scientists will work with you to determine the study design and power calculation most appropriate for your product and claim goals. Our clinical research team and GCP experts will recruit appropriate participants and execute your trial, ensuring compliance with ICH GCP guidelines.

Areas of Expertise

At INQUIS Clinical Research, we have extensive experience in designing and executing cholesterol-lowering studies. We can perform a power analysis to determine the sample size needed to detect an effect of your product and design and execute a trial to address your research objectives. With access to pools of participants with slightly elevated cholesterol levels, we can recruit the appropriate population for your clinical trial and research objectives. Cholesterol-lowering studies performed at INQUIS Clinical Research can also be used to support novel fiber claims. As part of our cholesterol-lowering studies, we can measure:

LDL cholesterol
Oxidized LDL cholesterol
HDL cholesterol
Apolipoprotein A1 (apoA1)
Apolipoprotein B (apoB)
Measures of inflammation

Contact us to learn how we can help you achieve your clinical research objectives.

Publications

Doma KM, Dolinar KF, Dan Ramdath D, Wolever TMS, Duncan AM. Canned Beans Decrease Serum Total and LDL Cholesterol in Adults with Elevated LDL Cholesterol in a 4-wk Multicenter, Randomized, Crossover Study. J Nutr. 2021;151(12):3701-3709. doi:10.1093/jn/nxab323

Ms Wolever T, Rahn M, Dioum E, et al. An Oat β-Glucan Beverage Reduces LDL Cholesterol and Cardiovascular Disease Risk in Men and Women with Borderline High Cholesterol: A Double-Blind, Randomized, Controlled Clinical Trial. J Nutr. 2021;151(9):2655-2666. doi:10.1093/jn/nxab154

Wolever TMS, Rahn M, Dioum EH, et al. Effect of Oat β-Glucan on Affective and Physical Feeling States in Healthy Adults: Evidence for Reduced Headache, Fatigue, Anxiety and Limb/Joint Pains. Nutrients. 2021;13(5):1534. Published 2021 May 1. doi:10.3390/nu13051534

Ho HVT, Jovanovski E, Zurbau A, Blanco Mejia S, Sievenpiper JL, Au-Yeung F, Jenkins AL, Duvnjak L, Leiter L, Vuksan V. A systematic review and meta-analysis of randomized controlled trials of the effect of konjac glucomannan, a viscous soluble fiber, on LDL cholesterol and the new lipid targets non-HDL cholesterol and apolipoprotein B. Am J Clin Nutr 2017;105(5):1239-1247. doi: 10.3945/ajcn.116.142158.

Ho HV, Sievenpiper JL, Zurbau A, Blanco Mejia S, Jovanovski E, Au-Yeung F, Jenkins AL, Vuksan V. The effect of oat β-glucan on LDL-cholesterol, non-HDL-cholesterol and apoB for CVD risk reduction: a systematic review and meta-analysis of randomised-controlled trials. Br J Nutr 2016;116(8):1369-1382. doi: 10.1017/S000711451600341X.

Ho HV, Sievenpiper JL, Zurbau A, Blanco Mejia S, Jovanovski E, Au-Yeung F, Jenkins AL, Vuksan V. A systematic review and meta-analysis of randomized controlled trials of the effect of barley β-glucan on LDL-C, non-HDL-C and apoB for cardiovascular disease risk reductioni-iv. Eur J Clin Nutr 2016;70(11):1239-1245. doi: 10.1038/ejcn.2016.89. Review.

Padhi E, Hawke A, Blewett H, Wolever TMS, Duncan A, Ramdath D. Soy flour muffins do not improve risk factors for cardiovascular disease in adults with hypercholesterolemia. FASEB J 2015;29(1_supplement):259.5.

Wolever TM, Tosh SM, Gibbs AL, et al. Physicochemical properties of oat β-glucan influence its ability to reduce serum LDL cholesterol in humans: a randomized clinical trial. Am J Clin Nutr. 2010;92(4):723-732. doi:10.3945/ajcn.2010.29174

INQUIS Clinical Research has extensive experience in conducting research trials that examine attenuation of glucose responses. With both short-term measures of glucose response and long-term measures of glucose tolerance, we can conduct the trial that is best suited to your goals.

Measuring postprandial insulin levels is an important component of clinical trials, to ensure that insulin levels are not disproportionately increased in relation to glucose response. With acute studies measuring postprandial insulin response as well as long-term studies of insulin sensitivity, we are able to address your research needs.

Contact us to learn how we can help you achieve your clinical research objectives.

Publications

Livesey G, Taylor R, Livesey HF, Jenkins DJA, Wolever TMS, et al. Dietary Glycemic Index and Load and the Risk of Type 2 Diabetes: Assessment of Causal Relations. Nutrients 2019, 11(6), 1436. https://doi.org/10.3390/nu11061436.

Wolever TMS, Jenkins AL, Yang J, Nisbet M, Johnson J, Chu YF, Pan Y. An optimized, slowly digested savory cluster reduced postprandial glucose and insulin responses in healthy human subjects. Curr Dev Nutr 2019;nzz006. doi: 10.1093/cdn/nzz006.

Wolever TMS, Jones PJH, Jenkins AL, Mollard RC, Wang H, Johnston A, Johnson J, Chu YF. Glycaemic and insulinaemic impact of oats soaked overnight in milk vs. cream of rice with and without sugar, nuts, and seeds: a randomized, controlled trial. Eur J Clin Nutr 2019;73(1):86-93. doi: 10.1038/s41430-018-0329-1.

Wolever T, Jenkins A, Prudence K, Johnson J, Duss R, Chu Y, Steinert RE. Effect of adding oat bran to instant oatmeal on glycaemic response in humans – a study to establish the minimum effective dose of oat β-glucan. Food Funct 2018;9(3):1692-1700. doi:10.1039/c7fo01768e

Tsilas CS, de Souza RJ, Mejia SB, et al. Relation of total sugars, fructose and sucrose with incident type 2 diabetes: a systematic review and meta-analysis of prospective cohort studies. CMAJ. 2017;189(20):E711-E720. doi:10.1503/cmaj.160706

Augustin LSA, Chiavaroli L, Campbell J, Ezatagha A, Jenkins AL, Esfahani A, Kendall CW. Post-prandial glucose and insulin responses of hummus alone or combined with a carbohydrate food: a dose–response study. Nutr J 2015;15(1). doi:10.1186/s12937-016-0129-1.

Campbell JE, Glowczewski T, Wolever TMS. Controlling subjects’ prior diet and activities does not reduce within-subject variation of postprandial glycemic responses to foods. Nutr Res 2003;23:621-29.

Wolever TMS, Jenkins AL, Campbell J, Ezatagha A, Pan Y, Nisbet M, Harkness L. Effect of an optimized savory cluster on glycemic and insulinemic responses in healthy individuals: a randomized, cross-over study. FASEB J. 2016;30(1_supplement):lb389-lb389.

Wolever TMS, Mehling C. High-carbohydrate/low-glycaemic index dietary advice improves glucose disposition index in subjects with impaired glucose tolerance. Brit J Nutr 2002;87:477-87. doi: 10.1079/BJNBJN2002568.

Wolever TMS, Mehling C. Long-term effect of varying source or amount of dietary carbohydrate on postprandial plasma glucose, insulin, triacylglycerol and free fatty acid concentrations in subjects with impaired glucose tolerance. Am J Clin Nutr 2003;77:612-21. doi: 10.1093/ajcn/77.3.612.

Chiasson JL, Josse RG, Leiter LA, Mihic M, Nathan DM, Palmason C, Cohen RM, Wolever TMS. The effect of acarbose on insulin sensitivity in subjects with impaired glucose tolerance. Diabetes Care 1996;19:1190-3. doi: 10.2337/diacare.19.11.1190.

At INQUIS Clinical Research, we have experience designing and conducting trials that examine lipid profiles, blood pressure changes, weight loss, and measures of inflammation. Our clinic can also investigate risk factor calculation and examine novel risk factors for cardiovascular disease. With an extensive participant database, we can recruit the appropriate study population for your research objectives.

Contact us to learn how we can help you achieve your clinical research objectives.

Publications

Au-Yeung F, Zurbau A, Khan T, Mejia SB, Liu Q, Ayoub-Charette S, De Souza RJ, Wolever TMS, Leiter LA, Kendall CWC, Sievenpiper JL. Important food sources of fructose-containing sugars and cardiovascular outcomes: a systematic review and meta-analysis of prospective cohort studies. Can J Cardiol. 2018;34(10):S25-S26.

Vuksan V, Xu ZZ, Jovanovski E, Jenkins AL, Beljan-Zdravkovic U, Sievenpiper JL, Mark Stavro P, Zurbau A, Duvnjak L, Li MZC. Efficacy and safety of American ginseng (Panax quinquefolius L.) extract on glycemic control and cardiovascular risk factors in individuals with type 2 diabetes: a double-blind, randomized, cross-over clinical trial. Eur J Nutr. 2018;24. doi: 10.1007/s00394-018-1642-0.

Ho HV, Sievenpiper JL, Zurbau A, Blanco Mejia S, Jovanovski E, Au-Yeung F, Jenkins AL, Vuksan V. The effect of oat β-glucan on LDL-cholesterol, non-HDL-cholesterol and apoB for CVD risk reduction: a systematic review and meta-analysis of randomised-controlled trials. Br J Nutr. 2016 Oct116(8):1369-1382. doi: 10.1017/S000711451600341X

Khan TA, Tayyiba M, Agarwal A, Mejia SB, de Souza RJ, Wolever TMS, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. Relation of Total Sugars, Sucrose, Fructose, and Added Sugars With the Risk of Cardiovascular Disease: A Systematic Review and Dose-Response Meta-analysis of Prospective Cohort Studies. Mayo Clin Proc. 2019 Dec;94(12):2399-2414. doi: 10.1016/j.mayocp.2019.05.034.

Jovanovski E, Lea-Duvnjak-Smircic, Komishon A, Au-Yeung F, Zurbau A, Jenkins AL, Sung MK, Josse R, Vuksan V. Vascular effects of combined enriched Korean Red ginseng (Panax Ginseng) and American ginseng (Panax Quinquefolius) administration in individuals with hypertension and type 2 diabetes: A randomized controlled trial. Complement Ther Med. 2020 Mar;49:102338. doi: 10.1016/j.ctim.2020.102338.

Li D, Nishi SK, Jovanovski E, Zurbau A, Komishon A, Mejia SB, Khan TA, Sievenpiper JL, Milicic D, Jenkins A, Vuksan V. Repeated administration of inorganic nitrate on blood pressure and arterial stiffness: a systematic review and meta-analysis of randomized controlled trials. J Hypertens. 2020 Nov;38(11):2122-2140. doi: 10.1097/HJH.0000000000002524.

Markers of chronic inflammation are important indicators of long term health risks. At INQUIS Clinical Research, we design and execute trials that examine cardiovascular disease risk factor profiles, as well as measure other markers of inflammation, including antioxidants, CRP, and interleukin 6 and 3. With an extensive participant database, including volunteers with mild illnesses, we can recruit the appropriate study population for your research objectives.

Contact us to learn how we can help you achieve your clinical research objectives.

Publications

Wang DD, Sievenpiper JL, de Souza RJ, Chiavaroli L, Ha V, Cozma AI, Mirrahimi A, Yu ME, Carleton AJ, Di Buono M, Jenkins AL, Leiter LA, Wolever TMS, Beyene J, Kendall CW, Jenkins DJ. The effects of fructose intake on serum uric acid vary among controlled dietary trials. J Nutr 2012;142(5):916-23. doi: 10.3945/jn.111.151951.

Wolever TMS, Gibbs AL, Mehling C, Chiasson J-L, Connelly PW, Josse RG, Leiter LA, Maheux P, Rabasa-Lhoret R, Rodger NW, Ryan EA. The Canadian trial of Carbohydrates in Diabetes (CCD), a 1-y controlled trial of low-glycemic-index dietary carbohydrate in type 2 diabetes: no effect on glycated hemoglobin but reduction in C-reactive protein. Am J Clin Nutr 2008;87:114-25. doi: 10.1093/ajcn/87.1.114.

Ghorbani P, Santhakumar P, Hu Q, Djiadeu P, Wolever TM, Palaniyar N, Grasemann H. Short-chain fatty acids affect cystic fibrosis airway inflammation and bacterial growth. Eur Respir J 2015;46(4):1033-45. doi: 10.1183/09031936.00143614.

Tracking changes in body composition over time with a specific treatment helps to better understand the mechanism of action as well as potential long-term effects. At INQUIS Clinical Research, our research includes DEXA (dual energy x-ray absorptiometry) scans to determine changes in fat composition over time, as well as BIA (bioelectrical impedance analysis) to monitor changes body fat percentages over time.

Contact us to learn how we can help you achieve your clinical research objectives.

Publications

Vuksan V, Jenkins AL, Brissette C, Choleva L, Jovanovski E, Gibbs AL, Bazinet RP, Au-Yeung F, Zurbau A, Ho HV, Duvnjak L, Sievenpiper JL, Josse RG, Hanna A. Salba-chia (Salvia hispanica L.) in the treatment of overweight and obese patients with type 2 diabetes: A double-blind randomized controlled trial. Nutr Metab Cardiovasc Dis 2017;27(2):138-146. doi: 10.1016/j.numecd.2016.11.124.

Fernandes J, Su W, Rahat-Rozenbloom S, Wolever TM, Comelli EM. Adiposity, gut microbiota and faecal short chain fatty acids are linked in adult humans. Nutr Diabetes 2014;4:e121. doi: 10.1038/nutd.2014.23.

Layden BT, Yalamanchi SK, Wolever TMS, Dunaif A, Lowe WL JR. Negative association of acetate with visceral adipose tissue and insulin levels. Diabetes Metab Syndr Obes 2012;5:49-55. doi: 10.2147/DMSO.S29244.

Sievenpiper JL, de Souza RJ, Mirrahimi A, Yu ME, Carleton AJ, Beyene J, Chiavaroli L, Di Buono M, Jenkins AL, Leiter LA, Wolever TMS, Kendall CW, Jenkins DJ. Effect of fructose on body weight in controlled feeding trials: a systematic review and meta-analysis. Ann Intern Med 2012;156(4):291-304. doi: 10.7326/0003-4819-156-4-201202210-00007. Review.

Kochan AM, Wolever TM, Chetty VT, Anand SS, Gerstein HC, Sharma AM. Glycemic index predicts individual glucose responses after self-selected breakfasts in free-living, abdominally obese adults. J Nutr 2012 Jan;142(1):27-32. doi: 10.3945/jn.111.146571.

Services

INQUIS Clinical Research offers a complete suite of services to help you structure your trial from end to end. We ensure you receive a custom-designed program that covers every aspect of your research needs seamlessly from beginning to end. We can partner as intensively as needed for clients who require our expertise with only some aspects of their clinical trial.

Features of our clinical trial services include:

Protocol Development

Ethics Submission

Recruitment

Trial Execution

Clinical Trial Management

Biological Sample Analysis

Biostatistics Calculation

Publication

SR&ED Preparation

How can we help you achieve your research objectives?