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A triple-blinded crossover study to evaluate the short-term safety of sweet manioc starch for the treatment of glycogen storage disease type Ia.
Monteiro, VCL, de Oliveira, BM, Dos Santos, BB, Sperb-Ludwig, F, Refosco, LF, Nalin, T, Derks, TGJ, Moura de Souza, CF, Schwartz, IVD
Orphanet journal of rare diseases. 2021;(1):254
Abstract
BACKGROUND Glycogen storage disease type 1a (GSD Ia) is characterized by severe fasting hypoglycemia. The clinical management includes the administration of uncooked cornstarch (UCCS). Although such a diet approach is effective in achieving euglycemia, its impact on the quality of life of patients should be considered. In vitro analyses suggest a longer release of glucose when using sweet manioc starch (SMS). METHODS We compared the efficacy and safety of the administration of SMS and UCCS during a short-fasting challenge in patients with GSD Ia in a randomized, triple-blind, phase I/II, cross-over study. GSD Ia patients aged ≥ 16 years and treated with UCCS were enrolled. Participants were hospitalized for two consecutive nights, receiving UCCS or SMS in each night. After the administration of the starches, glucose, lactate and insulin levels were measured in 1-h interval throughout the hospitalization period. The procedures were interrupted after 10 h of fasting or in a hypoglycemic episode (< 3.88 mmol/L). RESULTS Eleven individuals (mean age: 21.6 ± 4.3 years; all presenting body mass index > 25 kg/m2) participated in the study. The average fasting period was 8.2 ± 2.0 h for SMS and 7.7 ± 2.3 h for UCCS (p = 0.04). SMS maintained euglycemia for a greater period over UCCS. Increased lactate concentrations were detected even in absence of hypoglycemia, not being influenced by the different starches investigated (p = 0.17). No significant difference was found in total cholesterol, HDL, triglycerides and uric acid levels in both arms. None of the patients showed severe adverse events. CONCLUSIONS SMS appears to be non-inferior to UCCS in the maintenance of euglycemia, thus emerging as a promising alternative to the treatment of GSD Ia.
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A phase 2 randomized controlled trial of oral resistant starch supplements in the prevention of acute radiation proctitis in patients treated for cervical cancer.
Sasidharan, BK, Ramadass, B, Viswanathan, PN, Samuel, P, Gowri, M, Pugazhendhi, S, Ramakrishna, BS
Journal of cancer research and therapeutics. 2019;(6):1383-1391
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Abstract
BACKGROUND Radiation induced proctitis is frequently encountered during the radiation therapy of cervical and prostate cancers that causes pain and occasionally with bleeding and may affect the continuity of radiation therapy. AIMS AND OBJECTIVES The purpose of the study is to look at the benefit of administration of an oral prebiotic amylase resistant starch in reducing the incidence of acute radiation proctitis, a distressing symptom in patients receiving radiation therapy for cancer of the cervix. MATERIAL AND METHODS The study was conducted between 2011 and 2014 in 104 patients receiving radical chemo-radiotherapy for carcinoma cervix. Patients were randomized in to two arms, one receiving 30 gm of resistant starch and the other digestible starch on a daily basis throughout the course of the external radiotherapy. All patients received standard 4-field box radiation portals, 50 Gy in 25 fractions with 4 cycles of weekly concurrent Cisplatin. At completion of external beam radiotherapy, all patients underwent LDR/HDR brachytherapy. The study was double blinded and allocation was concealed from the investigators. The investigator recorded the radiotherapy related toxicity of the patients according to CTC V 3.0. The incidence and severity of grade 2-4 diarrhoea and proctitis were documented on a weekly basis and compared across the two groups and analyzed. Stool short chain fatty acid concentrations were measured at baseline at 2nd and 4th week and after 6 weeks of completion of radiotherapy in both study placebo arms and reported. The pattern of microbiota in the stool were also estimated in all patients at 4 time points. Two patients who progressed during therapy were not included in the analyses and two patients discontinued the intervention. A per protocol analyses was done. RESULTS At analysis there were 50 patients in each arm. The severity of clinical proctitis was found to be similar in both groups of patients with 12.2 % of patients experiencing toxicity of grade 2 and above in digestible starch group versus 14.6% in the resistant starch group. Functional proctitis was similarly graded and it was found that 16.3 % patients in digestible starch group experienced toxicity against 10.2 % patients in the resistant starch group. This difference was seen at 4th week and continued in the subsequent weeks till the end of radiation. Both groups had similar reported toxicity at 6 weeks post intervention and similar incidence of grade 2 and above diarrhea. The resistant starch group was found to have 8% incidence as compared to 2% in the other group at the 5th and 6th week. The short chain fatty acid concentrations were not significantly different in the groups at any point. CONCLUSION The study did not demonstrate a significant benefit in administering resistant starch over and above normal diet to patients receiving pelvic radiotherapy. The reasons may be attributed to concurrent use of chemotherapy and decrease in intestinal probiotics. The use of digestible starch in the control arm may have contributed to lower incidence of the toxicity endpoints as well.
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Starch-entrapped microsphere fibers improve bowel habit but do not exhibit prebiotic capacity in those with unsatisfactory bowel habits: a phase I, randomized, double-blind, controlled human trial.
Rasmussen, HE, Hamaker, B, Rajan, KB, Mutlu, E, Green, SJ, Brown, M, Kaur, A, Keshavarzian, A
Nutrition research (New York, N.Y.). 2017;:27-37
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Abstract
Approximately one-third of individuals in the United States experience unsatisfactory bowel habits, and dietary intake, especially one low in fiber, could be partly responsible. We hypothesized that intake of a fermentable fiber (starch-entrapped microspheres, SM) that has a delayed, slow fermentation profile in vitro would improve bowel habit while exhibiting prebiotic capacity in those with self-described unsatisfactory bowel habits, all with minimal adverse effects. A total of 43 healthy volunteers completed a 3-month, double-blind, parallel-arm randomized clinical trial to assess the ability of a daily dose (9 or 12 g) of SM vs psyllium (12 g) to improve bowel habit, including stool consistency and frequency, and modify gut milieu through changes in stool microbiota and short-chain fatty acids while remaining tolerable through minimal gastrointestinal symptoms. All outcomes were compared before and after fiber treatment. Stool frequency significantly improved (P=.0003) in all groups after 3 months, but stool consistency improved only in both SM groups compared with psyllium. In addition, all groups self-reported a similar improvement in overall bowel habit with fiber intake. Both SM and psyllium resulted in minimal changes in microbiota composition and short-chain fatty acid concentrations. The present study suggests that supplementation with a delayed and slow-fermenting fiber in vitro may improve bowel habit in those with constipation, but further investigation is warranted to determine capacity to alter microbiota and fermentation profiles in humans. This trial was registered at ClinicalTrials.gov as NCT01210625.
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Green tea extract decreases starch digestion and absorption from a test meal in humans: a randomized, placebo-controlled crossover study.
Lochocka, K, Bajerska, J, Glapa, A, Fidler-Witon, E, Nowak, JK, Szczapa, T, Grebowiec, P, Lisowska, A, Walkowiak, J
Scientific reports. 2015;:12015
Abstract
Green tea is known worldwide for its beneficial effects on human health. However, objective data evaluating this influence in humans is scarce. The aim of the study was to assess the impact of green tea extract (GTE) on starch digestion and absorption. The study comprised of 28 healthy volunteers, aged 19 to 28 years. In all subjects, a starch (13)C breath test was performed twice. Subjects randomly ingested naturally (13)C-abundant cornflakes during the GTE test (GTE 4 g) or placebo test. The cumulative percentage dose recovery (CPDR) was significantly lower for the GTE test than for the placebo test (median [interquartile range]: 11.4% [5.5-15.5] vs. 16.1% [12.7-19.5]; p = 0.003). Likewise, CPDR expressed per hour was considerably lower in each point of the measurement. In conclusion, a single dose of green tea extract taken with a test meal decreases starch digestion and absorption.
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The metabolic effect of resistant starch and yoghurt on the renal and faecal nitrogen and ammonia excretion in humans as measured by lactose-[(15)N2]ureide.
Wutzke, KD, Scholübbers, D
Isotopes in environmental and health studies. 2013;(4):464-70
Abstract
Resistant starch (RS) and Lactobacillus acidophilus yoghurt (LC1) were supplemented simultaneously in healthy adults to evaluate the effect on the urinary and faecal nitrogen and ammonia excretion by means of lactose-[(15)N2]ureide ((15)N-LU) degradation. Nineteen subjects received a regular daily diet either without or with supplementation of an RS-LC1-mixture composed of fibre of potatoes (RS type 1), wrinkle pea starch (RS type 2), and LC1 over a 20-day period in randomised order. Thereafter, (15)N-LU was administered together with breakfast. Urine and faeces were collected over a period of 48 and 72 h, respectively. The (15)N abundances were measured by isotope ratio mass spectrometry. The intake of the pre- and probiotic mixture composed of RS of type 1, type 2 and of LC1 significantly lowered the colonic generation and the renal excretion of toxic (15)NH3 and functioned as an ammonia shift from urinary to faecal (15)N excretion when using (15)N-LU as a xenobiotic marker.
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Transcatheter arterial chemoembolization using cisplatin powder mixed with degradable starch microspheres for colorectal liver metastases after FOLFOX failure: results of a phase I/II study.
Nishiofuku, H, Tanaka, T, Matsuoka, M, Otsuji, T, Anai, H, Sueyoshi, S, Inaba, Y, Koyama, F, Sho, M, Nakajima, Y, et al
Journal of vascular and interventional radiology : JVIR. 2013;(1):56-65
Abstract
PURPOSE To report the results of a phase I/II study of a transcatheter arterial chemoembolization protocol using cisplatin powder and degradable starch microspheres (DSM) for unresectable colorectal liver metastases after failure of FOLFOX (5-flourouracil, leucovorin plus oxaliplatin) chemotherapy conducted to determine the recommended dose of cisplatin powder and to assess the efficacy and safety of the protocol. MATERIALS AND METHODS A fine-powder formulation of cisplatin was mixed with DSM and administered via the hepatic artery every 4 weeks. In phase I, three cohorts of patients received escalating doses of cisplatin powder: 50 mg/m(2), 65 mg/m(2), and 80 mg/m(2). In phase II, tumor response, toxicity, and survival times were assessed. RESULTS The study enrolled 24 patients. Previously, FOLFOX had been administered to all patients, an irinotecan-containing regimen had been administered to 12 patients, and bevacizumab or cetuximab or both had been administered to 14 patients. In phase I, dose-limiting toxicity did not appear at any level, and the recommended dose of cisplatin powder was determined to be 80 mg/m(2). In phase II, a tumor response rate of 61.1% was achieved. The median hepatic progression-free survival and overall survival were 8.8 months (95% confidence interval [CI], 4.06-13.5 mo) and 21.1 months (95% CI, 8.37-33.8 mo). The following grade 3 toxicities were observed: thrombocytopenia (12.5%), aspartate transaminase elevation (33.3%), alanine transaminase elevation (12.5%), hyponatremia (8.3%), and cholecystitis (4.2%). CONCLUSIONS This study shows that transcatheter arterial chemoembolization with cisplatin powder at a dose of 80 mg/m(2) mixed with DSM is well tolerated and can produce a high response rate with a long survival time for patients with unresectable colorectal liver metastases after failure of FOLFOX.
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Lack of efficacy of a starch-thickened preterm formula on gastro-oesophageal reflux in preterm infants: a pilot study.
Corvaglia, L, Aceti, A, Mariani, E, Legnani, E, Ferlini, M, Raffaeli, G, Faldella, G
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2012;(12):2735-8
Abstract
BACKGROUND Gastro-oesophageal reflux (GOR) is common in preterm infants; conservative interventions (i.e. dietary changes) should represent the first-line approach. AIM: To evaluate by combined pH and impedance monitoring (pH-MII) the effect of a new preterm formula thickened with amylopectin (TPF) on GOR features in symptomatic preterm infants. METHODS Twenty-eight symptomatic preterm newborns underwent a 24-hour pH-MII; each baby received eight meals (four of TPF and four of a preterm formula [PF]). GOR indexes (number, acidity, duration and height of GORs) after TPF and PF meals were compared by Wilcoxon Signed Ranks Test. Viscosity of PF and TPF was measured. RESULTS TPF significantly decreased the number of acid GORs detected by pH-monitoring (TPF vs. PF: median 20 vs. 24.5, p = 0.009), while it had no influence on Reflux Index (RIpH), nor on acid and non-acid GOR indexes detected by MII, GOR physical features, and GOR height. TPF's viscosity was extremely higher than PF's, and further increased at pH 3 after the addition of pepsin. CONCLUSIONS The new formula was found to reduce the number of acid GORs detected by pH-monitoring; it did not reduce neither total oesophageal acid exposure nor non-acid GORs. At present its extended clinical use cannot be recommended.
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Macronutrient absorption characteristics in humans with short bowel syndrome and jejunocolonic anastomosis: starch is the most important carbohydrate substrate, although pectin supplementation may modestly enhance short chain fatty acid production and fluid absorption.
Atia, A, Girard-Pipau, F, Hébuterne, X, Spies, WG, Guardiola, A, Ahn, CW, Fryer, J, Xue, F, Rammohan, M, Sumague, M, et al
JPEN. Journal of parenteral and enteral nutrition. 2011;(2):229-40
Abstract
BACKGROUND Diet may play an important role in the management of patients with short bowel syndrome who have colon in continuity. However, macronutrient absorption has not been well characterized, and the most appropriate dietary constituents have not been well defined. OBJECTIVE To define carbohydrate absorption characteristics in patients with short bowel syndrome and determine the potential role of pectin as a dietary substrate. METHODS The authors studied the effect of a custom pectin-based supplement in 6 subjects (3 male/3 female) aged 29-67 years with jejunocolonic anastomosis, 4 of whom required long-term parental nutrition. Small intestinal absorption capacity, macronutrient and fluid balance, gastrointestinal transit time, and energy consumption were measured. RESULTS Data showed that 53% nitrogen, 50% fat, and 32% total energy were malabsorbed. In contrast, the majority (92%) of total carbohydrate was utilized. Fecal short-chain fatty acids (SCFAs) were increased, an indication of increased fermentation. Although only 4% of starch was recovered in stool, it is indicative of considerable starch malabsorption, thus providing the main carbohydrate substrate, for colonic bacterial fermentation. In contrast, nonstarch polysaccharide was a relatively minor fermentation substrate with only 49% utilized. Eighty percent of the pectin was fermented. Supplementation was associated with increased total SCFAs, acetate, and propionate excretion. There was a trend observed toward greater fluid absorption (-5.9% ± 54.4% to 26.9% ± 25.2%) following pectin supplementation. Nonsignificant increases in gastric emptying time and orocolonic transit time were observed. CONCLUSION Despite malabsorption, starch is the primary carbohydrate substrate for colonic bacterial fermentation in patients with short bowel syndrome, although soluble fiber intake also enhances colonic SCFA production.
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The addition of raspberries and blueberries to a starch-based food does not alter the glycaemic response.
Clegg, ME, Pratt, M, Meade, CM, Henry, CJ
The British journal of nutrition. 2011;(3):335-8
Abstract
It is now known that health benefits associated with diets rich in fruit and vegetables may be partly derived from intake of polyphenols. Berry polyphenols may influence carbohydrate metabolism and absorption and hence postprandial glycaemia. To date, studies related to polyphenol effects on the glycaemic response have been completed only in liquids using either monosaccharides or disaccharides. It remains to be determined whether berries known to be rich in polyphenols can reduce the glycaemic response (GR) to a solid polysaccharide meal. The aim of the present study was to investigate whether berries alter postprandial hyperglycaemia and consequently the GR to a starchy food. Blood glucose was tested on seven occasions, on three occasions using a reference food and on four occasions using pancakes supplemented with either raspberries or blueberries or control pancakes containing similar amounts of fructose and glucose. Results showed that there were no differences in GR (blueberry 51·3 (SEM 5·7); raspberry 54·7 (SEM 5·6); blueberry control 43·9 (SEM 4·2); raspberry control 41·8 (SEM 6·4)), GR area under the curve or satiety index between any of the tests. The present study indicates that the ability of berries to reduce blood glucose from starch-based foods is unsubstantiated.
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[Value of a new thickened formula in infants with regurgitations].
Chevallier, B, Fournier, V, Logre, B, Beck, L, Ceccato, F, Hui Bon Hoa, G, Lachambre, E, Van Egroo, LD, Sznajder, M
Archives de pediatrie : organe officiel de la Societe francaise de pediatrie. 2009;(4):343-52
Abstract
OBJECTIVES The purpose of this open multicenter study was to evaluate the value of a new starch-thickened formula in infants with regurgitations in ambulatory pediatric practice. POPULATION AND METHODS The study population comprised full-term infants with an age at inclusion of 1-90 days, who were bottle-fed and presented regurgitations. The formula tested was an infant formula-thickened with starch (2g/100mL). The primary endpoint was the frequency of bottles regurgitated, expressed in percentage of meals per day after 15 days of feeding with the preparation studied. Secondary endpoints were the assessment of regurgitations using the Vandenplas' score, as well as the daily increase in weight, height, and cranial circumference, overall and gastrointestinal tolerance, and formula acceptability. RESULTS Sixty-four infants presenting regurgitation were included. The frequency of bottles regurgitated estimated at 80.3% at inclusion significantly decreased at D3, D15, and D30 to 40.1, 40.2 and 37.2% (P<0.0001), respectively. Thirty percent of infants did not present regurgitations at all at D30. Similarly, a significant decrease in the Vandenplas' score was observed from 1.9 at D0 to 0.9 at D30 (P<0.0001). Infant growth was similar to the French and European growth curves. CONCLUSION The results showed rapid and lasting improvement in decreasing the frequency of feeding-bottles regurgitated by 50% from the first 3 days of using this new starch-thickened formula (2g/100mL). These satisfying results encourage the use of the tested formula in cases of infant regurgitation, in line with the European Society of Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommendations.