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Novel Soy Germ Pasta Enriched in Isoflavones Ameliorates Gastroparesis in Type 2 Diabetes

OBJECTIVE To determine the effect of soy germ pasta enriched in biologically active isoflavone aglycons on gastric emptying in type 2 diabetic patients with gastroparesis. RESEARCH DESIGN AND METHODS This randomized double-blind, placebo-controlled study compared soy germ pasta with conventional pasta for effects on gastric emptying. Patients (n = 10) with delayed gastric emptying consumed one serving per day of each pasta for 8 weeks, with a 4-week washout. Gastric emptying time (t1/2) was measured using the [13C]octanoic acid breath test at baseline and after each period, and blood glucose and insulin concentrations were determined after oral glucose load. RESULTS Soy germ pasta significantly accelerated the t1/2 in these patients (161.2 ± 17.5 min at baseline vs. 112.6 ± 11.2 min after treatment, P = 0.009). Such change differed significantly (P = 0.009) from that for conventional pasta (153.6 ± 24.2 vs. 156.2 ± 27.4 min), without affecting glucose or insulin concentrations. CONCLUSIONS These findings suggest that soy germ pasta may offer a simple dietary approach to managing diabetic gastropathy.


Study design:
In this randomized, double-blind, placebo controlled cross-over design neither the patients nor the researchers were aware of the randomization schedule. The 10 patients were randomly assigned to two groups; 5 patients were assigned to a group that was given a daily serving of soy germenriched pasta (80g) for 8 weeks, and the other 5 patients (control group) consumed the same amount of conventional pasta for the same period. Both pastas were consumed either at lunchtime or in the evening on the background of a standard ADA diabetic diet consisting of 55% CHO as energy, 30% of lipid, 15% protein. Compliance to the diets was monitored by a diet questionnaire. After a 4-week washout period during which time neither pasta was consumed, the participants were then given the two pastas in reverse sequence for an additional 8 weeks. At baseline (visit 1) and then at the end of each phase of the trial, 8-wk (visit 2), 12-wk (visit 3) and 20-wk (visit 3), blood (10 mL) was obtained for the measurement of fasting and postprandial glucose and insulin concentrations in response to a standard meal. Blood samples were taken at time 0, 30, 60, 90, and 120 min following the standardized meal which consisted of 125 g of bread, 35 g of cooked ham, 35 g of cheese and an apple. The macronutrient content the meal was total protein 23.1 g, lipids 22.3 g, carbohydrates 83.7 g, and fiber 11.1 g with an energy value of 607 kcal.

Measurement of Gastric Emptying Time:
On the second day, gastric emptying time was measured by the [ 13 C]octanoic acid breath test [1,2] after administration of 91 mg of [ 13 C]octanoic acid in a standardized meal consisting of one scrambled egg, 50 g of prosciutto ham, 10 g of butter, 60 g of white bread, and 100 mL water. The total energy intake was 480 kcal with a macronutrient composition of total protein 19 g (24%), fat 16 g (44%), and carbohydrate 26 g (32%).

Symptomology assessed using the Gastroparesis Cardinal Symptom Index (GCSI) questionnaire:
The severity of symptoms of gastroparesis was assessed in each patient at baseline and after consuming the pastas for 8-weeks using a validated GCSI questionnaire [10] in which each patient assessed on a scale of 0 (none) to 5 (severe), the extent of the following 9 symptoms: nausea, retching, vomiting, stomach fullness, ability to finish a normal-sized meal, feeling of excessive postprandial fullness, loss of appetite, extent of bloating, and signs of a visibly larger stomach. Since these T2D patients were managed with diet alone we did not expect the patients to report severe symptoms despite the delayed t1/2. This was supported by the patient reported GCSI scores.
Analytical measurements: Plasma glucose was measured by using a glucose analyser using an oxidase method (Menarini, Firenze Italy). Serum insulin was assayed using a routine immunoassay. Plasma total and individual isoflavones were measured by GC-MS as described previously [9]. The octanoic acid breath test [1,2] was performed using a isotope ratio mass spectrometer (Delta S, Finnigan Matt, Bremen, Germany; ABCA Europa Scientific, Crewe, UK).

Data analysis:
This was a preliminary study and no sample-size calculations were performed when the study was planned. Group data are expressed as mean ± SEM, 95% confidence intervals (CI) or, in the case of GCSI data, medians and (range). Plasma glucose and insulin responses to standard meal were summarized as the mean value of the measures obtained from each patient after the standard meal. Data from this crossover study were analyzed according to Hills and Armitage [11]. Patient response to dietary intervention was the difference between the values obtained at the end and at the beginning of each diet intervention period. Lack of treatment by period interactions (sequence effects) was preliminarily addressed by testing equality of the mean response during both periods between the two groups defined by sequence of diets (i.e., between the group who received soy-enriched pasta in the first period followed by the conventional pasta in the second period, and the group fed the two pasta types in the reverse order). A significance level of p=0.10 was conservatively used for that test. Mann-Whitney tests were used to assess significance of the interaction, period, and treatment effects. As baseline samples were not collected under controlled conditions, to assess treatment effects we also performed an alternative analysis to the classical crossover study limited to a pairwise comparison of data from the end of each study period. To this purpose, the Wilcoxon signed-rank test for paired data was used. Differences in proportions were tested using Fisher's exact test or chi-square statistics. Statistical analyses were two-sided and performed using Stata Statistical Software (Version 11.2, Stata Corporation, College Station, TX). Analyses are based on the mean values of plasma glucose or insulin levels obtained after a standardized meal * p values for the difference between changes from baseline observed in the two pasta treatments according to (15). Significance values for the analysis limited to pairwise comparison of data from the end of each study period were p=0.2859 for glucose and p=0.3199 for insulin.