Volume 6, Issue 1

Provident News

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General Announcements

Provident is in the process of transferring its clinical operations from Bloomington, Indiana to the Chicago area. This move will create more efficiencies for our Sponsors by having our clinics and our administrative office closer to one another. Our Addison site is expanding to accommodate an increased number of visits while we actively plan for the opening of a second Chicago area research site. We would like to take this time to highlight our exercise physiology laboratory currently housed in the Addison, Illinois site:

Our Exercise Physiology Laboratory provides sponsors with numerous opportunities for exercise performance research. The laboratory features two metabolic carts for cardiopulmonary stress testing, exercise measurements of energy expenditure and substrate oxidation, and maximal oxygen consumption measurement with the use of either a treadmill or a cycle protocol. We have experience testing a variety of subject populations. The metabolic carts are also equipped with a canopy system for measurement of resting metabolic rate and substrate oxidation. In addition, the lab also features a cycle ergometer equipped for evaluation of maximal anaerobic capacity and power using the Wingate protocol.

Our experienced staff includes two PhD level exercise physiologists with research experience in a variety of exercise contexts, including endurance training and strength training.

Equipment:

  • Two Parvo Medics TrueOne® 2400 Metabolic Measurement Systems with two TMX425 Trackmaster® Treadmills and a Lode Corival V3 Cycle Ergometer
  • Monark Ergomedic 894 E Cycle Ergometer for measurement of anaerobic capacity 

  • Two Midmark IQecg™ Digital ECG’s for real-time ECG output during exercise

 

Staff Announcements

Provident is pleased to welcome Robyn Krueger to the Project Management department. Robyn has joined us as a Project Assistant and is quickly becoming a valuable member of the team. Robyn received a Bachelor of Arts in Psychology from Westminster College in Fulton, MO. Welcome Robyn!

The Addison site is pleased to welcome Doug Gibula to the staff as a Clinical Research Coordinator. Doug comes to Provident with several years of coordinator experience, much of which was spent in orthopedics and physical therapy. Doug received a Bachelor of Science in Biochemistry from Fort Lewis College in Durango, CO. Welcome Doug!

Provident is happy to announce the arrival of Valerie Kaden's baby boy! Charles Henry Kaden was born on March 29th, 2010 and is 8 lb 10 oz and 22 inches long. Everyone is doing well. Congratulations Val!

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Recent and Upcoming Publications

Maki KC, Dicklin MR, Davidson MH, Doyle RT, Ballantyne CM for the COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Baseline lipoprotein lipids and the low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to simvastatin therapy. Am J Cardiol. 2010 (in press).   
 
Bays HE, Maki KC, McKenney J, Snipes R, Meadowcroft A, Schroyer R, Doyle RT, Stein E. Long-term up to 24 month efficacy and safety of concomitant prescription omega-3-acid ethyl esters and simvastatin in hypertriglyceridemic patients.  Curr Med Res Opin.  2010; [E-pub ahead of print].
 
Alish CJ, Garvey WT, Maki KC, Sacks G, Hustead DS, Hegazi RA, Mustad VA.  A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes.  Diabetes Technol Ther.  2010 (in press).  
 
Maki KC. Underutilization of dietary adjuncts in dyslipidemia management.  Lipid Spin-Practical Pearls, 2009;7:15-34.  
 
Maki KC, Beiseigel JM, Jonnalagadda SS, Gugger CK, Reeves MS, Farmer MV, Kaden VN, Rains TM.  Whole grain ready-to-eat cereal, as part of a dietary program for weight loss, reduces low density lipoprotein cholesterol in adults with overweight and obesity more than a dietary program including low fiber control foods. J Am Diet Assoc. 2010;110:205-214. 
Bays HE, McKenney J, Maki KC, Doyle RT, Carter RN, Stein E.  Prescription omega-3-acid ethyl esters: effects on non-high-density lipoprotein cholesterol in combined hyperlipidemic patients when combined with escalating doses of atorvastatin. Mayo Clin Proc. 2010;85:122-128.

 

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Recent and Upcoming Abstracts/Presentations

Joint Conference – 50th Cardiovascular Disease Eipdemiology & Prevention – and – Nutrition, Physical Activity and Metabolism – 2010.  Fat mass, but not abdominal fat distribution, predicts C-reactive protein concentrations in overweight and obese men and women.  Maki KC, Rains TM, Bell M, Reeves MS, Farmer MV.  March, 2010.  
Abbott Diagnostics Audio-Web Educational Conference Series.  Non-HDL Cholesterol: An Overlooked Marker for Cardiovascular Disease Risk.  Maki KC, McConnell JP.  February, 2010.    
Pacific Lipid Association.  Maki KC.  Cardiovascular Disease Epidemiology and Risk Assessment: Masters in Lipidology Advanced Training and Board Review Course.  February, 2010.    
National Lipid Association – Scientific Sessions – 2010.  A plant sterol/stanol supplement in tablet form lowers LDL and non-LDL cholesterol in men and women with primary hypercholesterolemia.  Maki KC, Lawless A, Reeves MS, Dicklin MR, Jenks BH, Shneyvas E, Brooks J.  May, 2010.    
National Lipid Association – Scientific Sessions – 2010.  Effects of an insoluble fraction of soy protein vs. milk protein on plasma lipids and fecal bile acids in men and women with hypercholesterolemia.  Maki KC, Butteiger DN, Rains TM, Lawless A, Reeves MS, Schasteen C, Krul ES.  May, 2010.   
National Lipid Association – Scientific Sessions – 2010.  Stability of lipid responses to prescription omega-3 acid ethyl esters plus simvastatin over two years.  Maki KC, Harris WS, Lubin BC, Reeves MS, Dicklin MR.  May, 2010.   
National Lipid Association – Scientific Sessions – 2010.  Predictors of anterior and posterior wall carotid intima media thickness progression in men and women at moderate risk of coronary heart disease.  Maki KC, Davidson MH, Dicklin MR, Bell M.  May, 2010.  
National Lipid Association – Scientific Sessions – 2010.  Effects of vitamin D supplementation on 25-hydroxyvitamin D and markers of cardiovascular disease risk in subjects with high waist circumference.  Maki KC, Rubin MR, Wong LG, McManus JF, Jensen CD, Hubacher R, Lawless A.  May, 2010.  

Midwest Lipid Association.  Maki KC.  Cardiovascular Disease Epidemiology and Risk Assessment: Masters in Lipidology Advanced Training and Board Review Course.  May, 2010.  

National Lipid Association – Scientific Sessions – 2010. The Ins and Outs of Interpreting the Statistical Results of a Clinical Trial.  Maki KC. May, 2010. 
American Society for Nutrition – 9th Vahouhy Dietary Fiber Symposium.  Measurement Techniques for Insulin Sensitivity.  Maki KC. June, 2010. 
Nevada Dietetic Association.  Diet or Physical Inactivity: Which is the Major Cause of the Obesity and Diabetes Epidemics?  Maki KC.  April, 2010. 

Nutrition Adventure.  Recent Advances in Dietary Management of Dyslipidemias. Maki KC.  May, 2010.   
Institute of Food Technologists 10 – Annual Meeting + Food Expo.  Ensuring Quality Control in Human Nutrition Clinical Trials Through Good Clinical Practices.  Maki KC.  July, 2010.   
Institute of Food Technologists 10 – Annual Meeting + Food Expo.  The Impact of Dietary Fiber on Insulin Sensitivity.  Maki KC.  July, 2010.  
 
Experimental Biology – 2010.  Effects of consuming a yogurt containing plant sterols, as part of a Therapeutic Lifestyle Changes (TLC) diet, on men and women with primary hypercholesterolemia. Jonnalagadda SS, Maki KC, Reeves MS, Rains TM,  Witchger M.  April, 2010. 
Experimental Biology – 2010.  Reductions in 24-hour glucose (G), blood pressure (BP) and body weight (BW) in men and women with type 2 diabetes mellitus: A pilot study assessing the impact of a novel, simplifies approach to diet guidance.  Maki KC, Rubin KH, Matusheski NV, Rubin MR, Reeves MS, Kaden VN, Black RB.  April, 2010. 
Experimental Biology – 2010.  Dietary changes in men and women with type 2 diabetes mellitus: A pilot study assessing the impact of a novel, simplified approach to diet guidance.  Rubin KH, Matusheski NV, Maki KC, Rubin MR, Reeves MS, Kaden VN, Black RB.  April, 2010. 

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In the Literature

Whole-Grain Ready-to-Eat Oat Cereal, as Part of a Dietary Program for Weight Loss, Reduces Low-Density Lipoprotein Cholesterol in Adults with Overweight and Obesity more than a Dietary Program Including Low-Fiber Control Foods. J Am Diet Assoc. 2010;110:205-14.  Maki KC, Beiseigel JM, Jonnalagadda SS, Gugger CK, Reeves MS, Farmer MV, Kaden VN, Rains TM. 

Objective and Methods:  

Independently, weight loss and consumption of viscous fibers have been shown to lower low-density lipoprotein cholesterol (LDL-C) levels (1,2), but few studies have evaluated whether there is a benefit of combining both interventions (3).  This study evaluated whether consumption of whole grain ready-to-eat (RTE) oat cereal containing viscous fiber, as part of a weight loss program, lowers LDL-C levels and improves other cardiovascular disease risk markers more than a weight loss program with low-fiber control foods.

This randomized, parallel-arm controlled study included generally healthy men and women, 20 to 65 years of age, with body mass index ≥25 and ≤45 and plasma LDL-C levels of ≥130 mg/dL and ≤200 mg/dL.  The 144 free-living participants who completed the study consumed either two portions per day of whole-grain RTE oat cereal (Cheerios® providing ~3 g/day oat β-glucan; n=77) or energy matched low-fiber foods (n=67) as part of a reduced energy (~500 kcal/day target deficit) dietary program for  12 weeks.  Clinical outcome measurements included fasting lipoprotein levels, waist circumference, triceps skin fold thickness, and body weight. 

Results:   

The results of this study showed that LDL-C levels were reduced more with whole-grain RTE oat cereal vs. control (-8.7±1.0 vs. -4.3±1.1%, P=0.005).  In addition, levels of total cholesterol (-5.4 ±0.8 vs. -2.9 ±0.9%, P=0.038) and non-high-density lipoprotein (non-HDL-C, -6.3±1.0 vs. -3.3±1.1%, P=0.046) were lowered significantly more with whole-grain RTE oat cereal, whereas HDL-C and triglyceride levels were not significantly altered.  No significant difference was present in the average weight loss between the whole-grain RTE oat cereal group (-2.2±0.3 kg) and the control group (-1.7±0.3 kg, P=0.325).  However, waist circumference was reduced significantly more in the whole-grain RTE oat cereal group (-3.3±0.4 vs. -1.9±0.4 cm, P=0.012).  Triceps skin fold thickness and mid-arm circumference changes did not differ between treatment groups. 

Conclusions: 

This study demonstrates that consumption of whole-grain RTE oat cereal has favorable effects on blood lipid levels when consumed as part of a reduced energy dietary program in overweight and obese men and women with hypercholesterolemia.  Further research will be required to determine the long-term cardiovascular benefits to adherence of a diet containing RTE oat cereal and to further assess the influence of RTE oat cereal consumption on regional body fat distribution.   

Dr. Maki’s Commentary:  

The results of this study confirm previous findings indicating that consumption of beta-glucan from oats (a viscous fiber) reduces the LDL-C concentration.  The effects of viscous fibers on LDL-C appear to be additive to those of a reduced saturated fat and cholesterol diet (1,4) and, as shown in our study, a reduced energy diet.  
  
An intriguing observation in our study was that waist circumference was reduced to a greater degree in the oat cereal group than in the control group.  This was unexpected, but consistent with results from another trial in which men and women with metabolic syndrome showed greater reductions in abdominal fat mass when consuming a weight loss diet emphasizing whole grain consumption compared with a similar diet emphasizing refined grains (5).
 
Caution should be exercised in the interpretation of our results because changes in fat mass were not identical in the two groups.  However, the difference in waist circumference change remained significant in multivariate analysis after adjustment for the change in body weight.  An inverse association between whole grain and/or beta-glucan consumption and abdominal fat accumulation could have important implications for human health.  If this relationship is confirmed, investigations to provide a mechanistic explanation would be of great scientific interest.  

Citations: 

1.  Brown L, Rosner B, Willett WW and Sacks FM. Cholesterol-lowering effects of dietary fiber: a meta-analysis. Am J Clin Nutr. 1999;69:30-42.    

2.  Dattilo AM and Kris-Etherton PM. Effects of weight reduction on blood lipids and lipoproteins: a meta- analysis. Am J Clin Nutr. 1992;56:320-328.   

3.  National Cholesterol Education Program Expert Panel. Detection, evaluation, and treatment of high cholesterol in adults (Adult Treatment Panel III). Final report. http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf. Accessed October 31, 2009.   

4.  Maki KC. Underutilization of dietary adjuncts in dyslipidemia management. Lipid Spin-Practical Pearls. 2009;7:15-34.    

5.  Katcher HI, Legro RS, Kunselman AR, Gillies PJ, Demers LM, Bagshaw DM, Kris-Etherton PM. The effects of a whole grain-enriched hypocaloric diet on cardiovascular disease risk factors in men and women with metabolic syndrome. Am J Clin Nutr. 2008;87:79-90.  

 

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Books and Book Chapters

 
  • Maki KC, Rubin M. Cardiovascular Epidemiology and Characterization of Atherosclerotic Disease Risk Factors.  In: Toth PP, Cannon CP (eds).  Comprehensive Cardiovascular Care in the Primary Care Setting, Humana Press, 2010 (in press).

 

                     

 

 

  • Toth PP, Maki KC. Practical Lipid Management: London: John Wiley & Sons.  Practical Lipid Management: Concepts and Controversies, is a text on the clinical management of dyslipidemias. As its title suggests, the book provides a straightforward and practical approach to the identification and treatment of abnormalities in lipid metabolism. The target audience consists of family physicians, internists, nurse practitioners, physician assistants, cardiologists, endocrinologists and allied health professionals involved in the care of patients with lipid disorders.  The book is available for purchase at Amazon.com.

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  • The book Therapeutic Lipidology edited by Drs. Michael Davidson, Peter Toth and Kevin Maki is available for purchase at Amazon.com.

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  • Maki KC, Matsuo N, Dicklin MR. Clinical studies evaluating the benefits of diacylglycerol for managing excess adiposity. In: Katsuragi Y, Yasukawa T, Matsuo N, Flickinger BD, Tokimitusu I, and Matlock MG. (eds) Chapter 10. Diacylglycerol Oil, AOCS Press, 2nd ed. 2008.

     

  • Maki, KC and Dicklin M. How well do various lipids and lipoprotein measures predict cardiovascular disease morbidity and mortality. In: Toth PP, Sica D. (eds). Clinical Challenges in Lipid Disorders. Oxford: Clinical Publishing. June, 2008.

     

  • Huth PJ, Rains TM, Yang Yifan, Philips SM. Current and emerging role of whey protein on muscle accretion. In: Onwulata CI and Huth PJ. (eds) Chapter 13. Whey Processing, Functionality and Health Benefits. Wiley-Blackwell. 2008.

 

 

About Provident

Provident has a team of research professionals with extensive experience in the design and conduct of clinical trials to evaluate pharmaceuticals, medical and functional foods, dietary supplements and medical devices.

For more information, visit our web site: http://www.providentcrc.com.

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