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Shahzeidi M, Nadjarzadeh A, Rahmanian M, Salehi Abargouei A, Fallahzadeh H, Mogibian M et al . The Effect of Oat Bran Supplement on Fasting Blood Sugar and Glycosylated Hemoglobin in Patients with Gestational Diabetes Mellitus: Single-blind Randomized Clinical Trial. JNFS. 2019; 4 (1) :7-16
URL: http://jnfs.ssu.ac.ir/article-1-232-en.html
Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
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The Effect of Oat Bran Supplement on Fasting Blood Sugar and Glycosylated Hemoglobin in Patients with Gestational Diabetes Mellitus: Single-blind Randomized Clinical Trial
Maedeh Shahzeidi; MSc1,2, Azadeh Nadjarzadeh; PhD1,2*, Masoud Rahmanian; MD3,
Amin Salehi Abarguoei; P
hD1,2, Hossein Fallahzadeh; PhD4, Mahdie Mogibian; MD5 & Shima Abdolahi; MSc1,2
1 Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
2Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
3Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
4 Department of Biostatistics and Epidemiology, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
5 Department of Obstetrics and Gynecology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
 
ARTICLE INFO ABSTRACT
ORIGINAL ARTICLE Background: Gestational diabetes mellitus (GDM) is known as a degree of glucose intolerance that occurs for the first time during pregnancy. There is paucity of evidence regarding the effect of oat bran on GDM. Oat as a source of β-glucan can be effective in reducing the blood sugar levels. This study aimed to investigate the effect of oat bran on fasting blood sugar (FBS) and glycosylated hemoglobin (HbA1c) in patients with GDM. Method: This single-blind clinical trial was conducted on 90 pregnant women with GDM. The experimental group (EG) consumed 30 g of oat bran daily with 100 g of low-fat yogurt before lunch and dinner for 4 weeks. The control group (CG) consumed only low-fat yogurt and both groups received nutrition counseling. The present study investigated the FBS, HbA1c, and weight gain at the beginning and after four weeks of intervention. Results: Out of 90 patients, 80 completed the study. FBS decreased in the EG (P = 0.04, -2.75 ± 8.22), whereas, it increased in the CG (P = 0.003, 4.37 ± 8.72). No significant difference was observed between the two groups in terms of HbA1c levels. Weight gain was controlled more efficiently in the EG than the CG (P = 0.001). Conclusion: The use of oat bran for four weeks decreased the FBS,; whereas, it did not affect HbA1c levels. Weight gain was controlled better in the EG than the CG.
Keywords: Diabetes; Pregnancy; Gestational diabetes mellitus; β-glucan; Blood glucose.
Article history:
Received: 13 May 2018
Revised: 3 Aug 2018
Accepted: 3 Nov 2018
 
IRCT2014112720114N1
*Corresponding author:
azadehnajarzadeh@gmail.com
Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
 
Postal code:1449614535
Tel: 09122022817
 
Introduction
Gestational diabetes (GDM) is known as a degree of glucose intolerance, which occurs for the first time during pregnancy (Association, 2014). The prevalence of GDM fluctuated between 1.7- 11.6percent in different studies (Viana et al., 2014). Today, the increasing trend of obesity in women is associated with the increase of GDM incidence (Jarmuzek et al., 2015). Studies showed that GDM caused many complications in the mother and fetus (Bellamy et al., 2009a, Gilmartin et al., 2008, Gunderson et al., 2014, Metzger et al., 2008). The main complication of the disease is the birth of a large baby regarding the gestational age. High birth weight is associated with birth trauma, infant hypoglycemia and respiratory distress syndrome (Jarmuzek et al., 2015), hypercalcemia and polycythemia (Jonsdottir, 2009), child obesity (Wei et al., 2007), cardiovascular disease and atherosclerosis (Gunderson et al., 2014, Wang et al., 2007), and diabetes (Wei et al., 2007) in the next years of the child's life. Shortly after the delivery, mother’s glucose levels return to the normal rate, but the risk of developing postpartum type2 diabetes is seven times higher in women with GDM(Bellamy et al., 2009b). Although various treatments are suggested for GDM, nutritional control seems to be the first solution (Asemi et al., 2013, Moreno-Castilla et al., 2016). The most important part of the nutritional intervention for controlling the hyperglycemia is reducing the consumption of refined carbohydrates and increasing the consumption of fiber from various sources, such as oat bran, green leaves, etc. (Brennan, 2005, Raninen et al., 2011). Some studies indicated that a carbohydrate-restricted diet was effective on metabolic control (Acheson, 2010) and resulted in better pregnancy outcomes (Lim et al., 2007) in women with GDM. In addition, a low glycemic index (LGI) diet was considered as a strategy to manage GDM (McGowan and McAuliffe, 2010). Several studies reported the improvement of lipid profiles with the use of oat bran (Berg et al., 2003). Consumption of oat bran (for four weeks) led to a significant increase in HDL-c and a decrease in the total cholesterol in obese postmenopausal women (Robitaille et al., 2005). A meta-analysis showed that daily intake of approximately 3 g of soluble fiber from oat-containing products reduced the plasma total cholesterol in hyperlipidemic and normolipidemic individuals (Ripsin et al., 1992). It was also reported in another meta-analysis that receiving 3g or higher amounts of β-glucan in the oats reduced the LDL-c and total cholesterol levels without altering the HDL-c and triglyceride levels (Whitehead et al., 2014). Oat bran reduced glucose levels after eating in both humans and animals (He et al., 2016, Montminy and Galibois, 1994). The hypoglycemic and hypolipidemic effects of the oat bran are due to the presence of β-glucan (Kerckhoffs et al., 2003). β-glucan in oats is useful for the treatment and prevention of type 2 diabetes (Braaten et al., 1994, Tapola et al., 2005). β-glucan can cause positive changes in the blood sugar and insulin response after consuming glucose (Wood et al., 2000). Despite many human studies and the fact that oat fiber compounds are almost different from other fibers, the effect of oat bran on pregnant women with GDM has not yet been studied. This study aimed to investigate the effect of the consumption of oat bran on fasting blood sugar (FBS), HbA1c, and weight changes in patients with GDM.
Materials and Methods
Type of study and participants: This single-blind clinical trial was conducted on 90 patients aged 20 to 40 years with GDM in the Imam Ali Clinic in Yazd, from December 2014 to September 2015. The inclusion criteria were the diagnosis of GDM by an endocrinologist based on the protocol (Metzger et al., 2010) (FBS of greater than 92 mg/dL, blood sugar higher than 180 mg/dL one hour after taking 75 g glucose, and blood sugar greater than 153 mg/dL two hours after consuming 75 g glucose in two consecutive experiments). The oral glucose tolerance test (OGTT) was performed after consuming 75 g of glucose by all the participants who enrolled in the study. The inclusion criteria consisted of lack of heart, liver, kidney diseases, andhypertension problems, willingness to participate in the study, non-participation in other research projects, lack of smoking, lack of excessive activity, lack of fiber supplementation (such as fiber clear or similar products), and non-compliance with other diets.The exclusion criteria were the presence of severe nausea and vomiting during pregnancy, a history of cancer/ celiac disease or other digestive diseases, allergic reactions to oats, twin pregnancy, breastfeeding in the past three months, hypertriglyceridemia-inducing syndromes (familial hypercholesterolemia), the presence of hypercholesterolemic syndromes, pre-pregnancydiabetes, and individuals who consumed less than 80 percent of the oat bran packs. Among those referring to the clinics affiliated to the Yazd University of Medical Sciences, 100 patients were eligible to enter the study.
Patients were randomly assignedto experimental (EG) and control groups (CG) using a random number table in each treatment group. The EG received 30 g of oat bran per day in addition to the nutritional counseling. The CG received only nutritional counseling. The oat bran supplement was purchased from Jam Noore Talaie Co. (Tehran, Iran). In order to remove the interfering effect of insulin or metformin, the group who needed insulin or metformin treatment was initially put on a two-week run-in period. Then, the participants with GDM received the recommended treatment regimen during the period mentioned above. When the insulin levels reached the fixed levels.
The CG and the EG received 100 g of low-fat yogurt and 100 g of low-fat yogurt plus 15 g of oat bran (a total of 30 g per day) before lunch and dinner, respectively. Allocation concealment was carried out using envelopes, in which the individual’s group, A or B, was written on a piece of paper and placed inside the envelope. The individual's row number was also written on the envelope.
The dietary adherence rate was measured using the food frequency questionnaire that was completed by the nutritionist at each visit. Patients were also asked to bring in the unused packages of the bran during each visit (every two weeks) so that their consumption rate could be accurately measured. The patients were also given the supplements supposed to be consumed during the next two weeks; the participants were monitored via telephone weekly during the study period. A table was also designed and provided to the patients to mark their consumption in the related cell. The adherence rate was estimated at 85 percent. Patients were advised to avoid changing their physical activity during the intervention. After the end of the four-week period of the study
Measurements: A form containing demographic and anthropometric indicators such as age, height, weight, gestational age, type of treatment, etc. were obtained from the patients. In order to investigate the individuals' diet status, a 24-hour dietary recall (24HR) was also taken from them. The patients were referred again to the laboratory for experiments the end of intervention. In order to control diet changes, anthropometric indices and 24HRwere obtained from the patients after the intervention. The level of physical activity was measured using Iranian version of international Physical Activity Questionnaire (Moghaddam et al., 2012). Blood samples were taken to determine the FBS and HbA1c levels after 12 hours of fasting. The FBS levels were measured using an enzyme colorimetric method based on the glucose level and by an auto-analyzer. The HbA1c levels were measured using the ion exchange chromatography.
Data analysis: The dietary intake and data analyses were performed by the Nutritionist IV and SPSS ver. 18, respectively. The Kolmogorov-Smirnov test was run to determine the distribution of the quantitative data. The paired t-test was applied to determine the significant differences at different times between the groups. The student t-test and ANCOVA were used to compare the changes of the continuous variables between the two groups. The confounders adjusted in the present study were changes in the energy and fiber intake, treatment protocol, and the third trimester of pregnancy. Furthermore, the Pearson chi-square test was used to compare the qualitative variables between the two studied groups. The data were reported as Mean ± SD, frequency, and percent. Moreover, P < 0.05 was considered as the significance level.
Ethical considerations: The subject, purpose, and method of the study were explained to all the participants by the researcher. Then, in the case of participants' willingness to cooperate in the study, they were asked to sign the written informed consent forms. To the best of our knowledge, no studies have ever been conducted on the adverse effects of bran and fiber on pregnant women (Afaghi et al., 2011). The proposal of this dissertation was presented at the Ethics Committee of the Vice-Chancellor of Research and Technology in Shahid Sadoughi University of Medical Sciences in Yazd in March 2014. This study was also ethically permitted with the Ethics Code of "164964/1/17 C". It was also registered in the Clinical Trials website of the Vice Chancellor for Research and Technology, Ministry of Health and Medical Education of Iran (www.irct.ir) with IRCT2014112720114N1 code.
Results
Of the 100 patients who were enrolled in the study, five, two, and three individuals wereexcluded due to reluctance to cooperate, unreasonable abortion, and other reasons, respectively. Consequently, a total of 90 individuals cooperated in the study, 10 of whom (five individuals from each group) were excluded during the intervention period due to personal reasons, lack of cooperation, and traveling. Finally, the data of 80 respondents were analyzed (Figure 1).Details of the primary characteristics of the patients are presented in Table 1. A total of 40, 20, and 20 patients were treated with the insulin (50%), metformin (25%), and treatment regimens (25%), respectively. None of the patients had diabetes before pregnancy. A total of seven (17.5%), 19 (47.5%), and 14 (35%) patients in the EG were in the first, second, and third trimester of pregnancy, respectively. A total of eight (20%), 17 (42.5%), and 15 (37.5%) patients in the CG were in the first, second, and third trimester of pregnancy, respectively. We observed no significant difference between the two groups in terms of indices except for the patients' height (P = 0.02). The level of physical activity in women with GDM was not significantly different between the two groups (P = 0.9).
The daily intake of energy and consumption of some nutrients before and after the intervention are shown in Table 2. The results show a significant difference between the two groups in terms of thefiber intake (P < 0.005).
As represented in Table 3, the weight gain was more evident in the CG than the oat bran group. In addition, changes in the mean weight, energy and fiber intake, treatment protocol, and the third trimester of pregnancy were significantly lower in the EG than the CG (P = 0.001). An increase was observed in the mean body mass index (BMI) of the CG at the end of the study (P < 0.005). The decrease in the mean fasting blood sugar levels was significant (P = 0.04) in the EG (Table 3). The increase in the mean FBS levels was also significant in the CG (P = 0.003). We adjusted for the difference in the initial concentration of the FBS level and by controlling the initial level, changes in the energy and fiber intake, the treatment protocol, and the third trimester of pregnancy. The results of ANCOVA on changes of the FBS indicated a significant statistical difference between the two groups (P = 0.006).As shown in Table 3, no significant difference was observed in the mean HbA1c level for the EG at the end of the study (P = 0.3). However, a significant difference was seen between the two groups at the end of the study (P = 0.05).




Discussion
The present study showed that the consumption of oat bran by patients with GDM caused a decrease in their FBS levels. However, it caused no significant difference in the level of HbA1c glycosylated hemoglobin. On the other hand, the consumption of oat bran led to a better control of the weight gain of diabetic pregnant mothers and, consequently, improved their BMI status. The present research was the first clinical study on the effects of oat bran on GDM. Recent studies indicated the effect of oat bran and β-glucan on diabetic patients (Afaghi et al., 2013, Boulet et al., 2003, Chen and Raymond, 2008, Group, 2006, Gupta et al., 2004, Hernandez-Cordero et al., 2008, Tapola et al., 2005). The findings of Pick et al.'s study, which are similar to those of the present study, showed that the insulin and glycemic responses were improved in eight men with type2 diabetes who consumed nine grams of oat bran for 12 weeks (Pick et al., 1996). In another study, Grove et al., showed that the fasting blood sugar levels were improved after consumption of 20gr of oat bran after for eight weeks (three grams of β-glucan) (Lovegrove et al., 2000). This effect can be explained by a possible mechanism: the viscosity of food increases inside the stomach (bolus) after consuming soluble fiber, which leads to an increase in the duration of gastric emptying and an increase in the bowel transit time (Wood, 2007). Moreover, a diet rich in fiber with low glycemic load causes a delay in the digestion and absorption of carbohydrates and thus, improves the fasting blood sugar status (Afaghi et al., 2013, Battilana et al., 2001). The effect of β-glucan can be explained by a possible mechanism: dosage, viscosity, and the formation of a gelatinous layer by β-glucan prevent from glucose uptake by enterocytes (Rebello et al., 2013, Reyna et al., 2003, Wood, 2007). β-glucans (and other soluble fibers) are known to slow down the blood sugar and insulin concentrations after taking a meal in both healthy people and people with type 2diabetes (Tappy et al., 1996). Cugnet-Anceau et al. showed that there was no change in the HbA1c levels among 53 patients with type 2 diabetes who consumed 3.5gr of β-glucan and had a normal diet for two months (Cugnet-Anceau et al., 2010). In addition, taking breakfast with LGI rather than breakfast with HGI over a four-week period had no effect on the HbA1c level in 13 men with type 2 diabetes (Kabir et al., 2002). Considering a 10-week meta-analysis, Brand-Miller et al. indicated that prescribing a LGI diet instead of a HGI diet had significantly decreased the HbA1c levels in people with type1 and type2 diabetes(Brand-Miller et al., 2003). Despite the decrease in the HbA1c levels from 5.72 ± 0.79 to 5.61 ± 48%, this decrease was not significant. The possible mechanism for explaining this effect can be related to the duration of the intervention; it seems that the four-week period is insufficient to make changes in the HbA1c level. Another reason that might be considered for the lack of significant difference in the HbA1c level is that both groups received the same diet, which can partly justify the fact that a diet can affect all people with GDM. Therefore, no difference was observed in the HbA1c levels since both groups received the dietary counseling. The findings of many studies have proved the positive effects of nutrition counseling and full grain intake on weight loss (Afaghi et al., 2013, Muktabhant et al., 2015). Weight gain during pregnancy is inevitable, but the weight gain in the control group was more evident than the experimental group and the mean weight changes in the two groups showed a significant difference. The weight may be affected by diet through several mechanisms, such as appetite control by the diet, improved metabolic function, or changes in insulin secretion and function. The results of several studies showed that consuming whole grain products and the LGI diet led to an increased sense of satiety, reduced the energy consumption, and controlled the appetite status by delaying the intake of carbohydrates, which resulted in weight loss (Porikos et al., 1982, Roberts and Heyman, 2000). Laboratory information suggests that consuming refined grains, unlike whole grains, increases fat synthesis in animals (Denyer, 1998), even when the total energy consumption is unchanged and the body weight remains constant. Although the incidence of GDM depends on the individuals' overweight and obesity before and during the pregnancy (Liu et al., 2003), we found that the oat bran prevented from excess weight gain during this period. One of the important limitations of this study was the lack of a placebo for the control group. Moreover, the short duration of the study limited the use of HbA1c as a reliable indicator of glucose control.
Conclusion
The results of the present study showed that consumption of 30g of the oat bran for four weeks reduced the level of fasting blood sugar and also controlled the weight gain in patients with GDM during pregnancy; whereas, it did not affect the HbA1c level.
Acknowledgment
Hereby, the authors express their appreciation to the respected patients who cooperated with the researchers during the study. The authors also thank the staff of the Imam Ali clinic and Diabetes Center in Yazd, who sincerely cooperated with the researchers. This article is the result of a master's thesis on health sciences in nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences.
Authors’ contribution
Shahzeidi M, Nadjarzadeh A, Rahmanian M participated in design, and coordinated the study and helped in the drafting and editing of the manuscript. Fallahzadeh H and Salehi Abarghuoei A participated in the statistical analyses, and participated in the drafting of the article. Mogibian M. participated in the design and the drafting of the article. Abdolahi S helped in drafting and editing the manuscript. All authors have read and approved the final version of the manuscript.
Conflict of interest
The authors of this article state no conflicts of interest regarding this study.
 
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Type of article: orginal article | Subject: public specific
Received: 2018/05/13 | Accepted: 2018/11/3 | Published: 2019/02/1

References
1. Acheson KJ 2010. Carbohydrate for weight and metabolic control: where do we stand? Nutrition. 26 (2): 141-145.
2. Afaghi A, Ghanei L & Ziaee A 2013. Effect of low glycemic load diet with and without wheat bran on glucose control in gestational diabetes mellitus: A randomized trial. Indian journal of endocrinology and metabolism. 17 (4): 689.
3. Afaghi A, et al. 2011. Effect of wheat bran on postprandial glucose response in subjects with impaired fasting glucose. Current topics in nutraceuticals research. 9 (1/2): 35.
4. Asemi Z, Tabassi Z, Samimi M, Fahiminejad T & Esmaillzadeh A 2013. Favourable effects of the Dietary Approaches to Stop Hypertension diet on glucose tolerance and lipid profiles in gestational diabetes: a randomised clinical trial. British journal of nutrition. 109 (11): 2024-2030.
5. Association AD 2014. Diagnosis and classification of diabetes mellitus. Diabetes care. 37 (Supplement 1): S81-S90.
6. Battilana P, et al. 2001. Mechanisms of action of beta-glucan in postprandial glucose metabolism in healthy men. European journal clinica nutrition. 55 (5): 327-333.
7. Bellamy L, Casas J-P, Hingorani AD & Williams D 2009a. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet (London, England). 373 (9677): 1773-1779.
8. Bellamy L, Casas JP, Hingorani AD & Williams D 2009b. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet (London, England). 373 (9677): 1773-1779.
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