Cross-linked phosphorylated RS4 wheat starch reduces glucose and insulin responses after 3 days of pre-feeding in healthy adults: an acute, double-blind, randomized controlled clinical trial.

When this project was designed, there was no evidence that adding resistant starch to available carbohydrate (avCHO) reduced glycaemic and insulinaemic responses (GIR). We compared GIR elicited by a cookie containing cross-linked phosphorylated RS4 wheat starch (Fibersym®) (RS4XL) versus an avCHO-matched control-cookie (CC) after n = 15 adults had consumed RS4XL or CC daily for 3-days using a double-blind, randomised, cross-over design. The difference in glucose iAUC over 0-2 h (primary endpoint) (mmol × min/L) after RS4XL, (mean ± SEM) 106 ± 16, versus CC, 124 ± 16, was not significant (p = 0.087). However, RS4XL reduced 0-90 min glucose iAUC (72 ± 9 vs 87 ± 9, p = 0.022), peak glucose concentration (6.05 ± 0.36 vs 6.57 ± 0.31 mmol/L, p = 0.017) and 0-2 h insulin iAUC (189 ± 21 vs 246 ± 24 nmol × h/L, p = 0.020). These results show that RS4XL reduced postprandial glycaemic and insulinaemic responses when added to avCHO, but do not prove that the products of its colonic fermentation are required for this effect.

Decreasing the RAG:SAG ratio of granola cereal predictably reduces postprandial glucose and insulin responses: a report of four randomised trials in healthy adults.

Dietary starch contains rapidly (RAG) and slowly available glucose (SAG). To establish the relationships between the RAG:SAG ratio and postprandial glucose, insulin and hunger, we measured postprandial responses elicited by test meals varying in the RAG:SAG ratio in n 160 healthy adults, each of whom participated in one of four randomised cross-over studies (n 40 each): a pilot trial comparing six chews (RAG:SAG ratio 2·4-42·7) and three studies comparing a test granola (TG1-3, RAG:SAG ratio 4·5-5·2) with a control granola (CG1-3, RAG:SAG ratio 54·8-69·3). Within studies, test meals were matched for fat, protein and available carbohydrate. Blood glucose, serum insulin and subjective hunger were measured for 3 h. Data were subjected to repeated-measures analysis of variance (ANOVA). The relationships between the RAG:SAG ratio and postprandial end points were determined by regression analysis. In the pilot trial, 0-2 h glucose incremental areas under the curve (iAUC0-2; primary end point) varied across the six chews (P = 0·014) with each 50 % reduction in the RAG:SAG ratio reducing relative glucose response by 4·0 %. TGs1-3 elicited significantly lower glucose iAUC0-2 than CGs1-3 by 17, 18 and 17 %, respectively (similar to the 15 % reduction predicted by the pilot trial). The combined means ± sem (n 120) for TC and CG were glucose iAUC0-2, 98 ± 4 v. 118 ± 4 mmol × min/l (P < 0·001), and insulin iAUC0-2, 153 ± 9 v. 184 ± 11 nmol × h/l (P < 0·001), respectively. Neither postprandial hunger nor glucose or hunger increments 2 h after eating differed significantly between TG and CG. We concluded that TGs with RAG:SAG ratios <5·5 predictably reduced glycaemic and insulinaemic responses compared with CGs with RAG:SAG ratios >54. However, compared with CG, TG did not reduce postprandial hunger or delay the return of glucose or hunger to baseline.

An Oat ß-Glucan Beverage Reduces LDL Cholesterol and Cardiovascular Disease Risk in Men and Women with Borderline High Cholesterol: A Double-Blind, Randomized, Controlled Clinical Trial.

BACKGROUND: High-molecular-weight (MW) oat ß-glucan (OBG), consumed at 3-4 g/d, in solid foods reduces LDL cholesterol by a median of ∼6.5%. OBJECTIVES: We evaluated the effect of a beverage providing 3 g/d high-MW OBG on reduction of LDL cholesterol (primary endpoint) when compared with placebo. METHODS: We performed a parallel-design, randomized clinical trial at a contract research organization; participants, caregivers, and outcome assessors were blinded to treatment allocation. Participants with LDL cholesterol between 3.0 and 5.0 mmol/L, inclusive [n = 538 screened, n = 260 ineligible, n = 23 lost, n = 48 withdrawn (product safety); n = 207 randomly assigned, n = 7 dropped out, n = 9 withdrawn (protocol violation); n = 191 analyzed; n = 72 (37.7%) male, mean ± SD age: 43.3 ± 14.3 y, BMI: 29.7 ± 5.2 kg/m2], were randomly assigned to consume, 3 times daily for 4 wk, 1 g OBG (n = 104, n = 96 analyzed) or rice powder (Control, n = 103, n = 95 analyzed) mixed into 250 mL water. Treatment effects were assessed as change from baseline and differences analyzed using a 2-sided t test via ANOVA with baseline characteristics as covariates. RESULTS: After 4 wk, change from baseline least-squares-mean LDL cholesterol on OBG (-0.195 mmol/L) was less than on Control (0.012 mmol/L) by mean: 0.207 mmol/L (95% CI: 0.318, 0.096 mmol/L; P = 0.0003); the following secondary endpoints were also reduced as follows: total cholesterol (TC) (0.226 mmol/L; 95% CI: 0.361, 0.091 mmol/L; P = 0.001), TC:HDL cholesterol ratio (0.147; 95% CI: 0.284, 0.010; P = 0.036), non-HDL cholesterol (0.194 mmol/L; 95% CI: 0.314, 0.073 mmol/L; P = 0.002), and Framingham cardiovascular disease (CVD) risk (0.474; 95% CI: 0.900, 0.049, P = 0.029). Changes in HDL cholesterol, triglycerides, glucose, and insulin did not differ between treatment groups (P > 0.05). Lipid treatment effects were not significantly modified by age, sex, BMI, or hypertension treatment. There were no major adverse events, but both treatments transiently increased gastrointestinal symptoms. CONCLUSIONS: Consuming a beverage containing 1 g high-MW OBG 3 times daily for 4 wk significantly reduced LDL cholesterol by ∼6% and CVD risk by ∼8% in healthy adults with LDL cholesterol between 3 and 5 mmol/L.This trial was registered at clinicaltrials.gov as NCT03911427.

Effect of Oat ß-Glucan on Affective and Physical Feeling States in Healthy Adults: Evidence for Reduced Headache, Fatigue, Anxiety and Limb/Joint Pains.

The gastrointestinal (GI) side-effects of dietary fibers are recognized, but less is known about their effects on non-GI symptoms. We assessed non-GI symptoms in a trial of the LDL-cholesterol lowering effect of oat ß-glucan (OBG). Participants (n = 207) with borderline high LDL-cholesterol were randomized to an OBG (1 g OBG, n = 104, n = 96 analyzed) or Control (n = 103, n = 95 analyzed) beverage 3-times daily for 4 weeks. At screening, baseline, 2 weeks and 4 weeks participants rated the severity of 16 non-GI symptoms as none, mild, moderate or severe. The occurrence and severity (more or less severe than pre-treatment) were compared using chi-squared and Fisher's exact test, respectively. During OBG treatment, the occurrence of exhaustion and fatigue decreased versus baseline (p < 0.05). The severity of headache (2 weeks, p = 0.032), anxiety (2 weeks p = 0.059) and feeling cold (4 weeks, p = 0.040) were less on OBG than Control. The severity of fatigue and hot flashes at 4 weeks, limb/joint pain at 2 weeks and difficulty concentrating at both times decreased on OBG versus baseline. High serum c-reactive-protein and changes in c-reactive-protein, oxidized-LDL, and GI-symptom severity were associated with the occurrence and severity of several non-GI symptoms. These data provide preliminary, hypothesis-generating evidence that OBG may reduce several non-GI symptoms in healthy adults.

Effect of a Snack Bar Optimized to Reduce Alcohol Bioavailability: A Randomized Controlled Clinical Trial in Healthy Individuals.

Alcohol intoxication impairs judgment and reaction times and the level of blood alcohol concentration (BAC) is highly correlated with accidents and injury. We hypothesized that a food optimized to delay gastric emptying, a reduced alcohol bioavailability bar (RABB), would decrease postprandial BAC and alcohol bioavailability with greater caloric-efficiency than control foods. Therefore, we evaluated the RABB in a randomized, crossover trial in 21 overnight fasted healthy adults (10 male, 11 female). Just before consuming a moderate dose of alcohol (0.3-0.35 g/kg body weight), participants ate either (1) no food (NF, 0 kcal), (2) the RABB (210 kcal), (3) a savory snack mix (SSM, 210 kcal), or (4) a multicomponent meal (MCM, 635 kcal) and their BAC was measured over 90 minutes using a breathalyzer, the primary endpoint being peak BAC (pBAC). pBACs were analyzed by repeated measures analysis of variance (ANOVA) (F = 107.5, P < .0001) with the differences between means assessed using Tukey's honestly significant difference test. The pBAC of each group was different (P < .001) from all other groups (NF = 0.064 ± 0.003, SSM = 0.047 ± 0.002, RABB = 0.031 ± 0.002, MCM = 0.020 ± 0.002%; mean ± standard error of the mean). Furthermore, the bioavailability of alcohol over 90 minutes (BA90) was reduced compared to the NF group by similar margins (SSM = 22.0 ± 2.2, RABB = 45.0 ± 3.8, MCM = 67.9 ± 3.1%) with the mean BA90 of each group different from all other groups (P < .001). Compared to the NF condition, the average reduction of pBAC per 100 calories of food consumed was higher for the RABB (24.0%) than either the SSM (11.8%) or the MCM (10.7%). This study demonstrates that the RABB can reduce both pBAC and alcohol bioavailability with high caloric-efficiency.

High-fiber cereal reduces postprandial insulin responses in hyperinsulinemic but not normoinsulinemic subjects.

OBJECTIVE: The objective of this study was to compare the plasma glucose and insulin responses elicited by two ready-to-eat breakfast cereals (one being high and the other being low in cereal fiber) and to see if the differences in response depended on subjects' fasting plasma insulin. RESEARCH DESIGN AND METHODS: Nondiabetic men (n = 77) were studied on two occasions after 10- to 14-h overnight fasts. They consumed 25 g of available carbohydrate from high- or low-fiber breakfast cereals in random order with blood taken at intervals for 2 h. Data from the 42 men with high fasting plasma insulin (FPI) on screening (>40 pmol/l) were compared with those from the 35 men with normal FPI (< or =40 pmol/l). RESULTS: Hyperinsulinemic men had significantly higher waist circumference and BMI, lower HDL cholesterol, and a trend toward higher triglycerides (P = 0.07) than control subjects. In all 77 subjects, the incremental area under the glucose response curve (AUC) after high-fiber cereal was 11.8 +/- 5.5% (P = 0.036) less than after low-fiber cereal with the reductions being equivalent in the hyperinsulinemic (12.6 +/- 8.3%) and control (10.9 +/- 9.1%) groups. However, insulin peak rise was reduced by the high-fiber cereal only in hyperinsulinemic men (351 +/- 29 vs. 485 +/- 55 pmol/l) but not in control subjects (211 +/- 20 vs. 220 +/- 20 pmol/l; cereal x group interaction P = 0.044). Insulin AUC after the high-fiber cereal, expressed as a percentage of that after low-fiber cereal, was negatively related to FPI (P = 0.009) but not to age, BMI, or waist circumference. CONCLUSIONS: The high-fiber cereal reduced glucose responses to the same extent in normal and hyperinsulinemic men, but reduced insulin responses only in hyperinsulinemic subjects.