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Journal of the American College of Nutrition, Vol. 25, No. 5, 409-414 (2006)
Published by the American College of Nutrition

Effect of a Viscous Fiber Bar on Postprandial Glycemia in Subjects with Type 2 Diabetes

Ann M. Flammang, PhD, RD, David M. Kendall, MD, C. John Baumgartner, MD, Trish D. Slagle, BA and Yong S. Choe, MAS

Ross Products Division of Abbott, Columbus, Ohio (A.M.F., T.D.S., Y.S.C.)
International Diabetes Center, Park Nicollet Institute, (D.M.K.)
Radiant Research Inc. (C.J.B.) Minneapolis, Minnesota

Address reprint requests to: Ann Marie Flammang PhD, RD, Ross Products Division of Abbott, 3300 Stelzer Rd, Columbus, OH 43219-3034. E-mail: ann.flammang{at}abbott.com


   ABSTRACT
TOP
 FOOTNOTES
 ABSTRACT
INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
 DISCUSSION AND CONCLUSIONS
 ACKNOWLEDGMENTS
 REFERENCES
 
Objective: To compare the effect of an experimental viscous fiber (VF) crispy bar on the postprandial glucose, insulin, and C-peptide response in adult subjects with type 2 diabetes to two commercially available control crispy bars.

Design: The study was a randomized, double-blinded, three period, crossover study.

Setting: The study was conducted at two sites: Park Nicollet Institute, International Diabetes Center, Minneapolis, MN, and Radiant Research, Inc., Minneapolis, MN.

Subjects: A total of 60 adults with type 2 diabetes taking oral antihyperglycemic medication participated in the study.

Intervention: After an overnight fast, subjects consumed a test meal containing an equicaloric amount (300 kcal) of an experimental VF crispy bar or one of two commercially available crispy bars at each of three test visits, followed by a four hour meal tolerance test. Subjects also completed gastrointestinal (GI) response records for the 24 hours following each test visit.

Results: The VF crispy bars produced significantly lower glucose (p < 0.0001), insulin (p < 0.0001), and C-peptide (p < 0.0001) responses (as measured by positive area under the curve) in subjects with type 2 diabetes, as compared with the two commercially available bars. Intensity (p < 0.05) and frequency (p < 0.05) of flatulence were significantly higher with the VF bar as compared with the 2 commercial bars. While the VF bar produced significant subjective GI tolerance scoring values, the mean value was below 3 on a scale of 0 (no effect) to 10 (most severe effect) for all tested materials.

Conclusions: The incorporation of VF into a crispy bar provided a means to improve blood glucose levels by reducing postprandial glucose, insulin, and C-peptide responses in subjects with type 2 diabetes. Though associated with some GI symptoms, VF may have application in improving the postprandial glycemic response in people with diabetes attempting intensive glucose control.

Key words: dietary fiber, glucose, insulin, C-peptide, type 2 diabetes


   INTRODUCTION
TOP
 FOOTNOTES
 ABSTRACT
 INTRODUCTION
RESEARCH DESIGN AND METHODS
 RESULTS
 DISCUSSION AND CONCLUSIONS
 ACKNOWLEDGMENTS
 REFERENCES
 
Blood glucose control is of established benefit and remains a central tenet of long-term management for patients with diabetes mellitus (DM). The risk of developing long-term complications, particularly microvascular complications, can be substantially reduced with the implementation of intensive glycemic control [1]. Dietary measures are an integral component of total diabetes care and management. The development and formulation of palatable food products containing novel ingredients that attenuate the postprandial glycemic excursion can enhance the use of nutrition as adjunctive therapy for people with diabetes.

Viscous forms of dietary fiber have been shown to improve blood glucose control [2,3] by trapping ingested carbohydrates inside the viscous gel formed after digestion. As a result, sugars are absorbed into the bloodstream more slowly, limiting the rise in blood glucose seen after a meal. While high viscosity appears to be necessary to maximize the benefits of fiber on blood glucose, it also reduces palatability. This decreased palatability presents a major hurdle to the practical use of viscous fiber; however, a palatable guar viscous fiber (VF) system has been developed to overcome these barriers.

Guar fiber is an isolated dietary galactomannan polymer obtained from maceration of the beans of the guar plant Cyamopsis tetragonoloba. The galactomannan molecules consist of a 1–4 linked ß-D-mannose backbone with {alpha}-(1–6) galactose branchpoints approximately every two mannose units [4]. Guar is Generally Recognized as Safe (GRAS, [21 CFR 184.1399]). Native guar galactomannan has a molecular weight of approximately 240 kDa; various processes effects the molecular size and therefore the viscosity of guar [4–6]. The desired application and functionality of guar for a food product depends on its molecular size [7]. Guar is typically added to food products at levels of less than 1% (1 g/100 g food) and functions as a gelling agent, thickener, stabilizer, firming agent, formulation aid and emulsifier [8]. Higher levels are generally not used due to concerns over palatability including excess stickiness and a gummy mouthfeel after swallowing [3,8].

Dietary supplementation with the viscous fiber guar gum is believed to reduce the rate of glucose absorption by slowing gastric emptying [9] and delaying gastrointestinal (GI) transit time [2]. When incorporated into foods and beverages, guar limited the excursion of blood glucose levels by reduction of the early phase glycemic excursion and maintenance of the later phase glycemic excursion in healthy subjects [10–12]. However, widespread development of guar as an potential ingredient for use in glycemic management has not been applied due to associated palatability issues. Continued product development with guar now permits its incorporation into additional food products, and novel technologies have been developed to overcome the negative influence of native guar gum on sensory characteristics within a food bar matrix [13]. For the VF crispy snack bar product, guar was incorporated into protein and starch crisps to minimize tooth-packing and throat catch. In addition, acidic pectin pieces were added to stimulate salivation and reduce the slimy mouthfeel of the guar. Although an experimental bar containing guar and protein crisps with an alginate filling has been shown to blunt postprandial glycemia in healthy non-diabetic subjects [14], no data was available regarding the effect of VF bars on subjects with diabetes.

The objective of the present study was to compare the postprandial glucose, insulin, and C-peptide responses as well as GI tolerance in adult type 2 DM subjects consuming an experimental guar VF crispy bar as compared to two commercially available control crispy bars.


   RESEARCH DESIGN AND METHODS
TOP
 FOOTNOTES
 ABSTRACT
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
RESULTS
 DISCUSSION AND CONCLUSIONS
 ACKNOWLEDGMENTS
 REFERENCES
 
Subjects
The study was conducted at two sites: Radiant Research (Minneapolis, MN) and the International Diabetes Center (Park Nicollet Institute) (Minneapolis, MN). Qualified subjects with type 2 DM on oral antihyperglycemic therapy between the ages of 18–75 inclusively were recruited, and informed consent obtained. The study protocol was approved by Schulman Associates Institutional Review Board, Inc. and the Institutional Review Board of Park Nicollet Health Services. Exclusion criteria included use of insulin, a BMI < 18 kg/m2 or > 35 kg/m2, actively treated infection or use of systemic antibiotic therapy in the last three weeks, significant cardiovascular event <12 weeks from study entry, active malignancy, chronic contagious infectious disease, end stage organ failure or status post organ transplant, regular use of tobacco products, intake of medication that would interfere with GI function, or known allergy to any study product ingredient. In addition, female subjects were included only if they were non-pregnant, non-lactating, and at least six weeks postpartum. A pregnancy test was required for all female subjects unless the subject had a hysterectomy, tubal ligation, or was > two years postmenopausal.

Study Design
The study was designed as a randomized, double-blinded, three period, crossover study. Sixty adults (41 male and 19 female with a mean age of 61 ± 1.2 years and mean BMI of 30.23 ± 0.43 kg/m2) with type 2 DM were enrolled for intent to treat (ITT) analysis; 52 subjects were protocol evaluable (PE) subjects based on a requirement that three test visits needed to be completed in order for a subject to be considered a completed and evaluable subject. Both ITT and PE data were analyzed; only ITT data is reported due to nearly identical results.

Subjects reported to the clinic for each test visit between 7:00 AM and 11:00 AM, after an overnight (10–16 hour) fast. Test visits were scheduled 7–14 days apart. To ensure that subjects had similar glycogen stores at test visits, subjects were instructed to consume a high carbohydrate diet (minimum 150 g/day average) for three days prior to each test visit. Subjects recorded all food and beverage intake for the three days preceding each test visit, and the intake record was reviewed at each visit to verify that subjects met the 150 g/day carbohydrate average for the three preceding days. In addition, the subjects were instructed not to consume alcohol or engage in strenuous exercise the day prior to each test visit. If the subject did not consume a high carbohydrate diet over the 3 days prior to the test visits or if the subject did not comply with test visit preparation (fasting, alcohol, exercise), then the subject did not proceed with the visit. Rescheduled visits could occur within the 7–14 day time frame from the previous visit.

Subjects continued all permitted prescribed medications except that subjects’ oral antihyperglycemic medications were withheld on the morning of the test visits. Subjects were instructed to bring their oral antihyperglycemic medications with them so that their medication could be taken following the completion of the test as considered appropriate. Medication use was reviewed at each visit.

To assure that subjects’ blood glucose levels were controlled, a capillary blood glucose measurement via glucose monitor was taken prior to administration of each test meal. Blood glucose levels were required to be less than 300 mg/dL to continue with the test visit. If blood glucose ≥ 300 mg/dL, the subject was exited from the study.

At the three scheduled test visits, subjects received in random order one of six different treatment sequences followed by a four-hour meal tolerance test (MTT). Subjects received all three treatments and therefore served as their own control. The crispy bar test meal was taken with 240 ml water at 0 time; meal and the water were consumed within 10 minutes.

Dietary Treatments
Subjects received one of three crispy bars at each test visit: either one of two commercially available control crispy bars (Control Bar 1: Pria® Nutritional Energy Snack Bar in Chocolate Honey Graham flavor by PowerBar® or Control Bar 2: Choice DM® Crispy Bar in Chocolate Peanut Butter flavor by Bristol Meyers Squibb Co.) or the experimental VF crispy bar (in Fudge Graham flavor by Ross Products Division). Bars were cut into bite size pieces to mask individual bar size differences. The portion size of each bar type was varied to provide approximately 300 kcal and 50 g of carbohydrate per serving (Table 1). Control bars were chosen as they were commercially available crispy bar products and therefore a comparable snack choice option readily available for people with diabetes. While the bar flavors were as closely matched as possible to one another, the control products were chosen from commercially available foods and flavor availability was not identical to the VF bar. The composition of the study products is shown in Table 1.


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  		Table 1. Study Product Composition

 
Blood Analysis
Venous blood samples were collected at specified times (–10 minutes time, and ± 5 minutes from 30, 45, 60, 90, 120, 180, and 240 minutes) during each MTT. Glucose, insulin and C-peptide were analyzed from venous blood samples obtained at each time point. Blood for glucose analysis was collected in tubes containing fluoride oxalate and inverted gently 10–12 times for distribution. After centrifugation for 10–15 minutes at 3000 RPM, plasma glucose was held at room temperature until analyzed on an Olympus 5200 instrument. Blood for insulin and C-peptide analysis was collected in serum separator tubes and coagulated for 30–60 minutes, then centrifuged for 10–15 minutes at 3000 RPM. Serum was frozen at –20°C until analyzed using the DPC Immulite 2000 Insulin assay and the DPC Immulite 2000 C-peptide assay. Quest Diagnostics Clinical Trials performed all laboratory analyses.

Gastrointestinal Tolerance
Subjects recorded subjective GI tolerance rating scores for 24 hours after test meal consumption. Frequency and intensity of nausea, cramping, distention, and flatulence were set to a 100 mm linear scale (0 = absent and 10 = severe for intensity and 0 = usual and 10 = more than usual for frequency). Subjects placed a single perpendicular slash mark across the scale to indicate their score for each variable.

Blinding
This was a double-blinded study. Neither the investigator(s), their research staff, appropriate members of RPD’s staff, nor subjects were informed of the identity of any of the study products during the clinical portion of the study. The site personnel did not analyze the contents of the study products or in any way seek to learn the identity of the study products. The blind was not broken during the study.

Statistical Analysis
Continuous variables in this crossover analysis were analyzed using repeated measures analysis of variance (ANOVA) with treatment and period as fixed effects and subject as random effect. Significant (p < 0.05) findings for treatment were investigated by examining pairwise comparisons of the least-squares means with Tukey-Kramer adjustment to the p-values. A result was declared to be statistically significant if and only if a p-value of an analysis was less than 0.05.

Sample Size
A sample size of 48 (eight per treatment sequence) subjects was determined to have 85% power to detect a difference between one control treatment with a mean positive AUC of 8418 mg · dl–1 · min and the other two treatments with the same mean of 6314 mg · dl–1 · min (25% difference), using a single-group repeated measures analysis of variance with a 0.05 significance level using nQuery Advisor® Release 4.0.


   RESULTS
TOP
 FOOTNOTES
 ABSTRACT
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
DISCUSSION AND CONCLUSIONS
 ACKNOWLEDGMENTS
 REFERENCES
 
The changes from baseline for glucose concentration at individual time points were significantly lower (p < 0.0001) at 30, 45, 60, 90, and 120 minutes for the VF crispy bar as compared to both control bars. No significant difference was found at 180 minutes, and the glucose concentration of the VF crispy bar was greater than Control Bar 1 at the 240 minute time point (see Fig. 1). The changes from baseline for insulin concentrations at individual time points were also significantly lower (p < 0.05) at 30, 45, 60, 90, 120, and 180 minutes for the VF crispy bar as compared to both control bars. No significant difference was found at 240 minutes (see Fig. 2). The changes from baseline for C-peptide concentration at individual time points were also significantly lower (p < 0.05) at 45, 60, 90, 120, 180, and 240 minutes for the VF crispy bar as compared to both control bars (data not shown). At 30 minutes, the VF crispy bar was lower as compared to only one (Control Bar 1) of two control bars (Fig. not shown). The primary endpoint assessed in the trial was the positive AUC for glucose, which was significantly lower (p < 0.0001) for the VF crispy bar as compared to both control bars. The results are shown in Fig. 3.


Figure 1
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  		Fig. 1. Data are expressed as Mean + S.E.M. p < 0.0001 1,2 > VF for 30–120 minutes, 1 > 2 for 30–90 min; p < 0.01 VF > 1 at 240 min.

 

Figure 2
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  		Fig. 2. Data are expressed as Mean + S.E.M. p < 0.05 1,2 > VF for 30–180 min; p < 0.05 1 > 2 at 30–120 min.

 

Figure 3
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  		Fig. 3. Data are expressed as Mean + S.E.M. p < 0.0001 1 > 2; * p < 0.0001 1,2 > VF

 
The secondary variables included positive AUC for insulin and C-peptide. For both insulin and C-peptide, consumption of the VF crispy bar was associated with significantly lower (p < 0.0001) measures of insulin and C-peptide than both of the control bars. The adjusted peak glucose concentrations for glucose, insulin, and C-peptide were also significantly lower (p < 0.001) for the VF crispy bar as compared to both control bars. Other secondary measures included the frequency and intensity of nausea, abdominal cramping, distention, and flatulence (0–24 h). Both control bars had significantly (p < 0.05) lower intensity of flatulence, and both control bars had a significantly (p < 0.05) lower frequency of flatulence as compared to the VF bar (see Figs. 4 and 5).


Figure 4
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  		Fig. 4. Data are expressed as Mean + S.E.M. p < 0.05 1,2 < VF

 

Figure 5
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  		Fig. 5. Data are expressed as Mean + S.E.M. p < 0.05 1,2 < VF

 

   DISCUSSION AND CONCLUSIONS
TOP
 FOOTNOTES
 ABSTRACT
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
 DISCUSSION AND CONCLUSIONS
ACKNOWLEDGMENTS
 REFERENCES
 
The addition of viscous fiber to food products has been shown to play an important role in controlling postprandial glycemic response in healthy individuals [10,11,14]. However, successful incorporation of dietary fiber into food products for the purpose of altering the rate of glucose absorption may be process or product dependent [15]. Use of guar as a potential glucose management tool has not been successful due to the nonpalatable characteristics of guar at increased levels. Incorporation of guar VF into a palatable crispy bar matrix has been recently accomplished [13]. The present study uniquely demonstrates that incorporation of guar VF into a crispy bar results in reduction in the postprandial glycemic response as compared to equicaloric amounts of two commercially available control crispy bars in those with type 2 diabetes. In addition to these improvements in glycemic response, the ingestion of the VF crispy bar resulted in significantly lower insulin and C-peptide responses as compared to the control bars. Improvements in glycemic excursion post-ingestion without substantial increments in insulin and C-peptide responses suggest that the delay in substrate delivery accounts for the lesser increase in glucose without further stimulating insulin secretion. Similarly, the short-term nature of our study suggests that weight changes and any possible change in insulin sensitivity, played little or no role in the observed results.

The control bars used in the study were chosen because they were commercially available comparable snack choice options available for people with diabetes. For this reason, the control bars did not have identical flavor or nutrient contents. The significance in effects observed in the study were likely due to the product composition and not attributed to the minor differences in flavor between the bars. While similar in carbohydrate and fat composition, the protein content between the bars did differ. Control Bar 2 supplied only 5 g of protein in the test meal as compared to 12 g in the VF crispy bar and 13.75 g in Control Bar 1. Diet modification of increased protein and lower carbohydrate has been shown to play a role in improving the hyperglycemia over time of type 2 diabetic subjects without weight loss or pharmacologic intervention [16]. However, protein does not slow the absorption of carbohydrate, and the peak glucose response to carbohydrate alone is similar to that of carbohydrate and protein [17]. Due to the presence of slowly digested carbohydrates such as sugar alcohols and fiber in Control Bar 2, the lower protein level of Control Bar 2 as compared to Control Bar 1 and the VF crispy bar likely did not have a major effect on the glycemic response noted.

Adverse effects (AEs) reported with the VF crispy bar included a significant increase in intensity and frequency of flatulence as compared to the control bars. These mild adverse effects are potentially attributable to the increased level of fiber received in the test meal of VF bars (11 g) as compared the test meals of Control Bar 2 (<5 g) or Control Bar 1 (0 g). Fiber intake is clearly associated with an increase in flatulence due to fermentation of the dietary fiber by anaerobic bacteria in the large bowel [18] and may be related to complaints of distention or flatulence. Given this known effect, it is recommended that dietary fiber be increased gradually to allow the GI tract time to adapt and limit intolerance. It should also be noted that while the intensity and frequency of flatulence was significantly higher with the VF bar, the mean subjective scoring values were below 3 on a scale of 0 (no effect) to 10 (most severe effect). Given these results, the benefits of increased fiber intake on glycemic control are achieved with a <30% increase in the intensity and frequency of GI side effects observed.

Additionally, the VF bar and Control Bar 2 test meal both contained approximately 15 g sugar alcohols. Sugar alcohols have a known dose dependent laxation effect [19]. Both Control Bar 2 and the VF bar had three subjects each reporting AEs of diarrhea, rated as either possibly related or probably related to product intake. Control Bar 1, which contained no sugar alcohols, did not have any AEs. It appears likely that laxation effect due to sugar alcohols may have played a role in this specific adverse GI effect.

In this study, the VF crispy bar resulted in significant improvement in postprandial glucose, insulin, and C-peptide responses as compared to equicaloric amounts of two commercially available control crispy bars in subjects with type 2 diabetes. As tight glycemic control is considered essential in limiting the risk of developing long-term complications of diabetes, such tools should have application for improving postprandial glucose control in people with diabetes attempting more intensive management.


   ACKNOWLEDGMENTS
TOP
 FOOTNOTES
 ABSTRACT
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
 DISCUSSION AND CONCLUSIONS
 ACKNOWLEDGMENTS
REFERENCES
 
The authors gratefully acknowledge the excellent work of the clinical study staff at Park Nicollet Institute, Radiant Research, Inc. and Ross Products Division who were involved in this study.


   FOOTNOTES
TOP
 FOOTNOTES
ABSTRACT
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
 DISCUSSION AND CONCLUSIONS
 ACKNOWLEDGMENTS
 REFERENCES
 
Dr. Kendall is presently at Amylin Pharmaceuticals, San Diego, California.

Received February 15, 2006. Accepted May 19, 2006.


   REFERENCES
TOP
 FOOTNOTES
 ABSTRACT
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
 DISCUSSION AND CONCLUSIONS
 ACKNOWLEDGMENTS
 REFERENCES
 

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