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Clinical Studies

 

National Starch has been collaborating with researchers around the world to investigate the health benefits of Hi-maize and Novelose resistant starches for many years.  The studies represented on this site are a selection of the research that exists today. As new research becomes available, we will make every effort to communicate in this space. Please check back regularly.

Select studies on Hi-maize and Novelose resistant starches

 

There is substantial research on the health benefits of natural Hi-maize and Novelose, including more than 120 peer-reviewed nutritional studies carried out over the last 15 years.  These studies illustrate that these benefits range from weight management, glycemic (blood sugar) management, energy management, and digestive health.  More than 40 studies in humans using natural Hi-maize and Novelose provides a high level of confidence that the benefits are reliable and real.  

 

Data confirm that different types of resistant starches deliver different benefits. Thus, benefits demonstrated by Hi-maize and Novelose cannot be extrapolated to other types of resistant starches.

 

Today, surveys show clearly that consumers seek the specific health benefits that Hi-maize and Novelose can provide (see Consumer Research section of this website). People are becoming increasingly aware of the importance of dietary fiber – and the differences between dietary fibers.  The particular benefits of Hi-maize and Novelose can be utilized to appeal to segments of consumers beyond those looking for dietary fiber. 

 

The volume and findings of research on natural resistant starch are compelling.  Below are just a few select studies:

  

Digestive Health

 

Hi-maize and Novelose promotes digestive health.

 

A new study1 led by Dr.Shusuke Toden, CSIRO Human Nutrition, Adelaide, Australia, and published in Cancer Biology & Therapy, showed natural resistant starch prevents colonic DNA damage induced by a high protein diet.  The study showed increased milk protein (cooked red meat and/or casein) in the diet increased colonic DNA damage, a biomarker indicating increased risk of colon cancer as damaged or mutated cells have the potential to develop into cancer,  The addition of Hi-maize to the diet, however,  prevented the damage.  It also prevented the thinning of the protective mucous layer. 

 

 [Toden S, Bird AR, Topping DL, Conlon MA.  Resistant starch prevents colonic DNA damage induced by high dietary cooked red meat or casein in rats.  Cancer Biology & Therapy 2006, 5:3; in press.

 

Prebiotic Fiber

 

A recently published study was led by Dr. Richard Le Leu at Flinders University in South Australia, and published in The Journal of Nutrition.  It demonstrated that the combination of Hi-maize and the probiotic bacteria Bifidobacterium lactis increases apoptosis (programmed cell death) of cells damaged by carcinogens by more than 30 percent.  The study also confirmed that Hi-maize reduced large intestinal pH, increased the growth of Lactobacilli and Bifidobacteria and increased short-chain fatty acids (SCFAs), including butyrate (all biomarkers for a healthy colon). Butyrate is the preferred energy source for healthy colon cells and is important for colon health.

 

[Le Leu RK, Brown IL, Hu Y, Bird AR, Jackson M, Esterman A, Young GP.  A synbiotic combination of resistant starch and Bifidobacerium lactis facilitates apoptotic deletion of carcinogen-damaged cells in rat colon.  The Journal of Nutrition 2005;135:996-1001.]

 

Glycemic Management: Healthy Blood Sugar Levels

 

Hi-maize and Novelose reduce the impact on blood sugar (glycemic) and blood insulin levels when replacing rapidly digestible carbohydrates such as flour.

 

Multiple studies have confirmed that when Hi-maize replaces flour or other rapidly digestible carbohydrates such as cornstarch, the glycemic (blood sugar) and blood insulin impact of that food is reduced.  Studies have been published by investigators around the world – i.e. Dr. M. Olesen at the University of Copenhagen and Dr. Manny Noakes at the CSIRO in Australia. Delayed or sustained energy release has also been demonstrated in some studies with consumption of resistant starch from high amylose corn.  Studies published by Dr. Kay Behall and her colleagues at the US Department of Agriculture have shown that the reductions in glycemic and insulin response are relative to the amount of RS incorporated into the food and increase with increasing amylose content of the corn starch. 

 

Dr. Denise Robertson and her colleagues at the Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, UK showed that consumption of Hi-maize increased insulin sensitivity in healthy people by 33%.  A 2003 study had demonstrated increased insulin sensitivity after 1 day – the 2005 study confirmed that increased insulin sensitivity was still seen after 4 weeks of Hi-maize consumption. This is important because insulin resistance is an underlying risk factor in metabolic syndrome, with increased risk for developing diabetes, obesity, and cardiovascular disease. 

 

[Olesen M, Rumessen JJ, Gudmand-Hoyer E. Intestinal transport and fermentation of resistant starch evaluated by the hydrogen breath test.  European Journal of Clinical Nutrition 1994;48(10):692-701.

 

Noakes M, Clifton PM, Nestel PJ, Le Leu R, McIntosh G. Effect of high-amylose starch and oat bran on metabolic variables and bowel function in subjects with hypertriglyceridemia. The American Journal of Clinical Nutrition 1996;64(6):944-51.

 

Behall KM, Scholfield DJ, Canary J. Effect of starch structure on glucose and insulin responses in adults.

The American Journal of Clinical Nutrition 1988;47(3):428-32.]

 

Behall KM, Hallfrisch J. Plasma glucose and insulin reduction after consumption of breads varying in amylose content. European Journal of Clinical Nutrition 2002;56(9):913-20.

 

Robertson MD, Bickerton AS, Dennis AL, Vidal H and Frayn KN: Insulin-sensitizing effects of dietary resistant starch and effects on skeletal muscle and adipose tissue metabolism.   The American Journal of Clinical Nutrition 2005;82:559–67.] 

 

Energy Management: Provides a Balance of Energy

 

Multiple studies have confirmed that when Hi-maize replaces flour or other rapidly digestible carbohydrates such as cornstarch, the glycemic (blood sugar) and blood insulin impact of that food is reduced.  Studies have been published by investigators around the world – i.e. Dr. M. Olesen at the University of Copenhagen and Dr. Manny Noakes at the CSIRO in Australia. Delayed or sustained energy release has also been demonstrated in some studies with consumption of resistant starch from high amylose corn.  Studies published by Dr. Kay Behall and her colleagues at the US Department of Agriculture have shown that the reductions in glycemic and insulin response are relative to the amount of RS incorporated into the food and increase with increasing amylose content of the corn starch. 

 

[Olesen M, Rumessen JJ, Gudmand-Hoyer E. Intestinal transport and fermentation of resistant starch evaluated by the hydrogen breath test.  European Journal of Clinical Nutrition 1994;48(10):692-701.

 

Noakes M, Clifton PM, Nestel PJ, Le Leu R, McIntosh G. Effect of high-amylose starch and oat bran on metabolic variables and bowel function in subjects with hypertriglyceridemia. The American Journal of Clinical Nutrition 1996;64(6):944-51.

 

Behall KM, Scholfield DJ, Canary J. Effect of starch structure on glucose and insulin responses in adults.

The American Journal of Clinical Nutrition 1988;47(3):428-32.]

 

Behall KM, Hallfrisch J. Plasma glucose and insulin reduction after consumption of breads varying in amylose content. European Journal of Clinical Nutrition 2002;56(9):913-20.

 

Weight Management

 

Resistant starch lowers calories when it replaces flour or other digestible carbohydrates.

 

Dr. Kay Behall and her colleagues at the US Department of Agriculture confirmed that high amylose corn RS2 does not yield the full 4 kilocalories per gram typical of flour, but yields between 2 - 3 kcal/gram.  Thus, when Hi-maize is used to replace flour, the caloric content of that food is reduced.  The energy is partially delivered in the small intestine through the digestion of the starch portion and part of the energy is delivered in the large intestine in the form of short-chain fatty acid by-products from the fermentation of the resistant starch.

 

An area of emerging importance for weight management is lipid oxidation.  A study recently published by Dr. Janine Higgins at University of Colorado suggests that eating just one meal containing high amylose corn RS2 resistant starch can increase lipid oxidation (fat-burning) in healthy people by 20-25%.  Additional studies are underway to determine the impact on body composition and weight over time in humans, but animal studies have already been published.  Dr. Dorota Pawlak at Harvard Medical School in Boston MA demonstrated that mice fed Hi-maize had approximately half as much body fat after 9 weeks as mice consuming a rapidly digested cornstarch diet.

  

[Behall, KM, Howe JC.  Resistant starch as energy.  The Journal of the American College of Nutrition 1996;15(3):248-54.

 

Higgins JA, Higbee DR, Donahoo WT, Brown IL, Bell ML, Bessesen DH, 2004. Resistant starch consumption promotes lipid oxidation. Nutrition & Metabolism 1:8.

 

Pawlak DB, Kushere JA, Ludwig DS. Effects of dietary glycaemic index on adiposity, glucose homeostasis, and plasma lipids in animals. Lancet 2004;364:778-85.]

  

Overview of human studies with resistant starch

 

The more than 120 studies on the benefits of resistant starch include in vitro models and animal models as well as human clinical trials.  Epidemiological studies are supportive as they have correlated starch consumption with reduced risk of colorectal conditions.

 

Animal and in vitro models are valuable, as they provide a wealth of information, including mechanisms.  However, human clinical trials are the most valuable in determining the physiological benefits of this type of resistant starch in humans. 

 

Here is a summary of relevant human studies with natural resistant starch (RS2):

  • 3 published studies have shown beneficial effects on outcomes relevant to weight management and metabolism. (Higgins 2004, Jenkins 1998, van Amelsvoort 1992)
  • 8 published studies have shown beneficial effects of Hi-maize on glucose and/or insulin response.  When substituted for flour, it lowers the glycemic and/or insulin response of foods in a dose dependent manner.  (Brown et al. 1995; Giacco et al. 1998; Noakes et al. 1996; Olesen et al. 1994; van Amelsvoort & Weststrate 1992; Vonk et al. 2000; Robertson et al. 2003; Robertson et al. 2005)
  • 2 published studies have shown that Hi-maize increased insulin sensitivity when added to the diet as a supplement.  (Robertson et al. 2003; Robertson et al. 2005)
  • 13 published studies have shown beneficial effects on biomarkers for colon health such as the production of short-chain fatty acids, lower pH, lower concentrations of ammonia and phenolics, decreased bile acids and increased fecal weight. (Alles et al. 1997; Birkett et al. 1996; Grubben et al. 2001; Heijnen et al. 1996; Heijnen et al. 1998; Hylla et al. 1998; Jenkins et al. 1998; Muir et al. 2004; Noakes et al. 1996; Phillips et al. 1995; Silvester et al. 1997; van Munster et al. 1994; Wacker et al. 2002)


Reference for Human Studies Above:

 

Alles MS, Katan MB, Salemans JMJI, Van Laere KMJ, Gerichhausen MJW, Rozendaal MJ, Nagengast FM. Bacterial fermentation of fructooligosaccharides and resistant starch in patients with an ileal pouch – anal anastomosis. The American Journal of Clinical Nutrition 1997;66:1286-92.

 

Birkett A, Muir J, Phillips J, Jones G, O'Dea K. Resistant starch lowers fecal concentrations of ammonia and phenols in humans. The American Journal of Clinical Nutrition 1996;63(5):766-72. 

 

Brown IL, McNaught KJ, Moloney E.  Hi-maize™: new directions in starch technology and nutrition.  Food Australia, June 1995;47(6):272-5. 

 

Giacco R, Clemente G, Brighenti F, Mancini M, D’Avanzo A, Coppola S, Ruffa G, La sorella G, Rivieccio AM, Rivellese AA, Riccardi G. Metabolic effects of resistant starch in patients with Type 2 diabetes.   Diabetes, Nutrition & Metabolism 1998;11:330-5.

 

Grubben MJ, van den Braak CC, Essenberg M, Olthof M, Tangerman A, Katan MB, Nagengast FM.   Effect of resistant starch on potential biomarkers for colonic cancer risk in patients with colonic adenomas: a controlled trial. Digestive Diseases and Science 2001;46(4):750-6.

 

Heijnen M-LA, van Amelsvoort JMM, Deurenberg P, Beynen AC.  Neither raw nor retrograded resistant starch lowers fasting serum cholesterol concentrations in healthy normolipidemic subjects.  American Journal of Clinical Nutrition 1996;64:312-8.

 

Heijnen M-LA, van Amelsvoort JMM, Deurenberg P, Beynen AC.  Limited effect of consumption of uncooked (RS2) or retrograded (RS3) resistant starch on putative risk factors for colon cancer in healthy men.  American Journal of Clinical Nutrition 1998;67:322-31.

 

Higgins JA, Higbee DR, Donahoo WT, Brown IL, Bell ML, Bessesen DH. Resistant starch consumption promotes lipid oxidation. Nutrition & Metabolism 2004;1:8.

 

Hylla S, Gostner A, Dusel G, Anger H, Bartram HP, Christl SU, Kasper H, Scheppach W. Effects of resistant starch on the colon in healthy volunteers: possible implications for cancer prevention. The American Journal of Clinical Nutrition 1998;67(1):136-42. 

 

Jenkins DJ, Vuksan V, Kendall CW, Wursch P, Jeffcoat R, Waring S, Mehling CC, Vidgen E, Augustin LS, Wong E. Physiological effects of resistant starches on fecal bulk, short chain fatty acids, blood lipids and glycemic index. Journal of the American College of Nutrition 1998;17(6):609-16.

 

Kendall, CWC, Jenkins DJA, Emam A.  Assessment of resistant starch tolerance: a dose response study. Abstract presented at 9th European Nutrition Conference, October 1-4, 2003, Rome, Italy.

 

Muir JG, Yeow EG, Keogh J, Pizzey C, Bird AR, Sharpe K, O'Dea K, Macrae FA. Combining wheat bran with resistant starch has more beneficial effects on fecal indexes than does wheat bran alone. The American Journal of Clinical Nutrition 2004;79(6):1020-8.

 

Noakes M, Clifton PM, Nestel P, Le Leu R, McIntosh G.  Effect of high-amylose starch and oat bran on metabolic variables and bowel function in subjects with hypertriglyceridemia.  The American Journal of Clinical Nutrition 1996;64(6):944-51.

 

Olesen M, Rumessen JJ, Gudmand-Hoyer E.  Intestinal transport and fermentation of resistant starch evaluated by the hydrogen breath test.  European Journal of Clinical Nutrition 1994;48(10):692-701.

 

Phillips J, Muir JG, Birkett A, Lu ZX, Jones GP, O’Dea K. Effect of resistant starch on fecal bulk and fermentation-dependent events in humans.  The American Journal of Clinical Nutrition 1995;62:121-30.

 

Robertson MD, Currie JM, Morgan LM, Jewell DP, Frayn KN. Prior short-term consumption of resistant starch enhances postprandial insulin sensitivity in healthy subjects. Diabetologia 2003;46(5):659-65.

 

Robertson MD, Bickerton AS, Dennis AL, Vidal H, Frayn KN.  Insulin-sensitizing effects of dietary resistant starch and effects on skeletal muscle and adipose tissue metabolism.  The American Journal of Clinical Nutrition 2005;82:559-567.

 

Silvester KR, Bingham SA, Pollock JRA, Cummings JH, O’Neill IK.  Effect of meat and resistant starch on fecal excretion of apparent N-nitroso compounds and ammonia from the human large bowel.  Nutrition and Cancer 1997;29(1):13-23.

 

van Amelsvoort JMM, Weststrate JA. Amylose-amylopectin ratio in a meal affects postprandial variables in male volunteers.  The American Journal of Clinical Nutrition 1992;55:712-8.

 

Van Munster IP, Tangerman A, Nagengast FM.  Effect of resistant starch on colonic fermentation, bile acid metabolism, and mucosal proliferation.  Digestive Diseases and Sciences 1994:39(4):834-842.

 

Vonk RJ, Hagedoorn RE, de Graaff R, Elzinga H, Tabak S, Yang YX, Stellaard F. Digestion of so-called resistant starch sources in the human small intestine. The American Journal of Clinical Nutrition 2000;72(2):432-8. 

 

Wacker M, Wanek P, Eder E, Hylla S, Gostner A, Scheppach W.  Effect of enzyme-resistant starch on formation of 1,N2-propanodeoxyguanosine adducts of trans-4-hydroxy-2-nonenal and cell proliferation in the colonic mucosa of healthy volunteers.  Cancer Epidemiology, Biomarkers and Prevention 2002;11:915-20.

 

 

 

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