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.

Neither low salivary amylase activity, cooling cooked white rice, nor single nucleotide polymorphisms in starch-digesting enzymes reduce glycemic index or starch digestibility: a randomized, crossover trial in healthy adults.

BACKGROUND: It was suggested that low salivary-amylase activity (SAA) and cooling or stir-frying cooked starch decreases its digestibility and glycemic index. OBJECTIVE: We determined the effects of SAA, cooling, and single-nucleotide polymorphisms (SNPs) in the salivary amylase (AMY1), pancreatic amylase (AMY2A, AMY2B), maltase-glucoamylase (MGAM), and sucrase-isomaltase (SI) genes on starch digestibility and glycemic index of cooked polished rice. METHODS: Healthy subjects [pilot, n = 12; main, n = 20 with low-SAA (<50 U/mL), and n = 20 with high-SAA (>105 U/mL)] consumed test meals containing 25 g (pilot) or 50 g (main) available carbohydrate at a contract research organization using open-label (pilot) or assessor-blinded (main), randomized, crossover, Latin-square designs (trial registration: NCT03667963). Pilot-trial test meals were dextrose, freshly cooked polished rice, cooked rice cooled overnight, stir-fried hot rice, or stir-fried cold rice. Main-trial test meals were dextrose, dextrose plus 10 g lactulose, plain hot rice, or plain cold rice. In both trials, blood glucose was measured fasting and at intervals over 2 h. In the main trial, breath hydrogen was measured fasting and hourly for 6 h to estimate in vivo starch digestibility. Data were analyzed by repeated-measures ANOVA for the main effects of temperature and stir-frying (pilot trial) or the main effects of SAA and temperature (main trial) and their interactions. Effects of 24 single nucleotide polymorphisms (SNPs) were assessed separately. Means were considered to be equivalent if the 95% CI of the differences were within ±20% of the comparator mean for glucose response/glycemic index or ±7% for digestibility. RESULTS: Pilot: neither temperature nor stir-frying significantly affected glucose incremental AUC (primary endpoint, n = 12). Main: mean ± SEM glycemic index (primary endpoint, n = 40) was equivalent for low-SAA compared with high-SAA (73 ± 3 vs. 75 ± 4) and cold rice compared with hot rice (75 ± 3 vs. 70 ± 3). Estimated starch digestibility (n = 39) was equivalent for low-SAA compared with high-SAA (95% ± 1% vs. 92% ± 1%) and hot rice compared with cold rice (94% ± 1% vs. 93% ± 1%). No meaningful associations were observed between genotypes and starch digestibility or glycemic index for any of the SNPs. CONCLUSIONS: The results do not support the hypotheses that low-SAA, cooling, and common genetic variations in starch-digesting enzymes affect the glycemic index or in vivo carbohydrate digestibility of cooked polished rice. This trial was registered at clinicaltrials.gov as NCT03667963.

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.

Acute glycemic and insulin response of Fossence™ alone, or when substituted or added to a carbohydrate challenge: A three-phase, acute, randomized, cross-over, double blind clinical trial.

Short chain fructo-oligosaccharides (scFOS) are well-recognized prebiotic fibers. Fossence™ (FOSS) is a scFOS that has been produced from sucrose via a proprietary fermentation process and has not been tested for its digestibility or glucose/insulin response (GR and IR, respectively). The present randomized, controlled, cross-over study was conducted in 3 phases to explore GR and IR to ingestion of FOSS, when replaced by/added to available-carbohydrates (avCHO) among 25 healthy adults (40 ± 14years). In each phase GR and IR elicited by 3-4 test-meals were measured among the fasted recruited subjects. The interventional test meals were as follows: Phase-1, water alone or 10g FOSS or 10g Dextrose in 250ml water; Phase-2, 250ml water containing Dextrose:FOSS (g:g) in the content as 50:0 or 50:15 or 35:0 or 35:15; Phase-3 portions of white-bread (WB) containing avCHO:FOSS (g:g) in the content as 50:0 or 50:15 or 35:0 or 35:15. Blood samples (finger prick method) were collected at fasting and 15, 30, 45, 60, 90 and 120 min after start of test meal ingestion. Plasma glucose and serum insulin were analyzed utilizing standard methods. The primary endpoint was differences in glucose IAUC. All subjects provided their written consent to participate in the study (ClinicalTrials.gov: NCT03755232). The results demonstrated that FOSS, when consumed alone, showed no raise in glycaemia or insulinemia and was statistically equivalent to response of water alone. GR and IR elicited by dextrose:FOSS and WB:FOSS test-meals of Phase 2 and Phase 3, were statistically equivalent to the respective test-meals without FOSS. Result of the 3 phases support the hypothesis that FOSS is resistant to breakdown and is indigestible in the human small-intestine, and therefore can be classified as an unavailable carbohydrate that does not raise post prandial blood glucose or insulin. FOSS, being sweet to taste, may be an acceptable sugar replacer in beverages without compromising their taste and sensory qualities.

Effect of Varying Molecular Weight of Oat ß-Glucan Taken just before Eating on Postprandial Glycemic Response in Healthy Humans.

To see if the molecular weight (MW) and viscosity of oat ß-glucan (OBG) when taken before eating determine its effect on postprandial glycemic responses (PPRG), healthy overnight-fasted subjects (n = 16) were studied on eight separate occasions. Subjects consumed 200 mL water alone (Control) or with 4 g OBG varying in MW and viscosity followed, 2-3 min later, by 113 g white-bread. Blood was taken fasting and at 15, 30, 45, 60, 90, and 120 min after starting to eat. None of the OBG treatments differed significantly from the Control for the a-priori primary endpoint of glucose peak-rise or secondary endpoint of incremental area-under-the-curve (iAUC) over 0-120 min. However, significant differences from the Control were seen for glucose iAUC over 0-45 min and time to peak (TTP) glucose. Lower log(MW) and log(viscosity) were associated with higher iAUC 0-45 (p < 0.001) and shorter TTP (p < 0.001). We conclude that when 4 g OBG is taken as a preload, reducing MW does not affect glucose peak rise or iAUC0-120, but rather accelerates the rise in blood glucose and reduces the time it takes glucose to reach the peak. However, this is based on post-hoc calculation of iAUC0-45 and TTP and needs to be confirmed in a subsequent study.

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.

Increasing oat ß-glucan viscosity in a breakfast meal slows gastric emptying and reduces glycemic and insulinemic responses but has no effect on appetite, food intake, or plasma ghrelin and PYY responses in healthy humans: a randomized, placebo-controlled, crossover trial.

BACKGROUND: The viscosity of oat ß-glucan (OBG) determines its effect on serum cholesterol and glycemic responses, but whether OBG viscosity affects gastric emptying, appetite, and ad libitum food intake is unknown. OBJECTIVES: We aimed to determine the effect of altering the amount or molecular weight (MW) and, hence, viscosity of OBG in a breakfast meal on the primary endpoint of food intake at a subsequent meal. METHODS: Overnight-fasted males (n = 16) and nonpregnant females (n = 12) without diabetes, aged 18-60 y, with BMI 20.0-30.0 kg/m² who were unrestrained eaters participated in a double-blind, randomized, crossover study at a contract research organization. Participants consumed, in random order, breakfast meals equivalent in weight, energy, and macronutrients consisting of white-bread, butter, jam, and 2% milk plus hot cereal [Cream of Rice (CR), or instant-oatmeal plus either 3 g oat-bran (2gOBG), 10 g oat-bran (4gOBG), or 10 g oat-bran plus ß-glucanase (4gloMW) to reduce OBG MW and viscosity compared with 4gOBG]. Gastric emptying, subjective appetite, and glucose, insulin, ghrelin, and peptide tyrosine tyrosine (PYY) responses were assessed for 3 h and then subjects were offered an ad libitum lunch (water and pizza). RESULTS: Pizza intakes (n = 28) after CR, 2gOBG, 4gOBG, and 4gloMW (mean ± SEM: 887 ± 64, 831 ± 61, 834 ± 78, and 847 ± 68 kcal, respectively) were similar (nonsignificant). Compared with CR, 4gOBG significantly reduced glucose (78 ± 10 compared with 135 ± 15 mmol × min/L) and insulin (14.0 ± 1.6 compared with 26.8 ± 3.5 nmol × min/L) incremental area-under-the-curve and delayed gastric-emptying half-time (geometric mean: 285; 95% CI: 184, 442, compared with geometric mean: 105; 95% CI: 95, 117 min), effects not seen after 4gloMW. Subjective appetite, PYY, and ghrelin responses after 2gOBG, 4gOBG, and 4gloMW were similar to those after CR. CONCLUSIONS: The results demonstrate that OBG viscosity determines its effect on postprandial glucose, insulin, and gastric emptying. However, we were unable to demonstrate a significant effect of OBG on appetite or food intake, regardless of its viscosity.This trial was registered at clinicaltrials.gov as NCT03490851.

Impact of oat processing on glycaemic and insulinaemic responses in healthy humans: a randomised clinical trial.

Oats can be processed in a variety of ways ranging from minimally processed such as steel-cut oats (SCO), to mildly processed such as large-flake oats (old fashioned oats, OFO), moderately processed such as instant oats (IO) or highly processed in ready-to-eat oat cereals such as Honey Nut Cheerios (HNC). Although processing is believed to increase glycaemic and insulinaemic responses, the effect of oat processing in these respects is unclear. Thus, we compared the glycaemic and insulinaemic responses elicited by 628 kJ portions of SCO, OFO, IO and HNC and a portion of Cream of Rice cereal (CR) containing the same amount of available-carbohydrate (23 g) as the oatmeals. Healthy males (n 18) and females (n 12) completed this randomised, cross-over trial. Blood was taken fasting and at intervals for 3 h following test-meal consumption. Glucose and insulin peak-rises and incremental AUC (iAUC) were subjected to repeated-measures ANOVA using Tukey's test (two-sided P<0·05) to compare individual means. Glucose peak-rise (primary endpoint, mean (sem) mmol/l) after OFO, 2·19 (sem 0·11), was significantly less than after CR, 2·61 (sem 0·13); and glucose peak-rise after SCO, 1·93 (sem 0·13), was significantly less than after CR, HNC, 2·49 (sem 0·13) and IO 2·47 (sem 0·13). Glucose iAUC was significantly lower after SCO than CR and HNC. Insulin peak rise was similar among the test meals, but insulin iAUC was significantly less after SCO than IO. Thus, the results show that oat processing affects glycaemic and insulinaemic responses with lower responses associated with less processing.

Post-prandial glucose and insulin responses of hummus alone or combined with a carbohydrate food: a dose-response study.

OBJECTIVES: Pulses are low glycemic index (GI) foods and have been associated with reduced risk of heart disease, diabetes and some cancers. However the blood glucose and insulin responses of hummus, a food containing chickpea, have not been thoroughly tested. METHODS: Ten healthy subjects each consumed 11 breakfast study meals in randomized order over a period of 15 weeks. Hummus was consumed alone at three doses (2.7 g, 10.8 g and 25 g available carbohydrate [avCHO] portions) and with 50 g avCHO from white bread at three doses (2.7 g, 5.4 g and 10.8 g avCHO portions). The responses elicited by hummus alone were compared with 25 g avCHO portions of white bread, while those after hummus plus white bread were compared with 50 g avCHO from white bread. Plasma glucose and serum insulin responses were monitored over two hours and the GI and insulin index (II) calculated using standard methodology. RESULTS: The GI and II of hummus were 15 ± 3 and 52 ± 13, respectively, and were significantly lower than white bread (P < 0.05). The glucose and insulin incremental area under the curve (IAUC) for hummus alone were significantly lower than white bread except for insulin IAUC of hummus 25 g avCHO. The peak rise of blood glucose and insulin after hummus were significantly lower than after white bread. Glucose and insulin IAUC after adding hummus to bread did not differ significantly from white bread alone. However the blood glucose 45 min after adding 25 g avCHO from hummus to white bread was significantly lower while at 120 min it was significantly higher than after white bread alone. CONCLUSIONS: This study demonstrated that, similar to chickpeas, hummus has a very low GI and II. Postprandial glucose responses were 4 times less than that of white bread and did not compromise insulin levels.

Glycemic effect of oat and barley beta-glucan when incorporated into a snack bar: a dose escalation study.

BACKGROUND: The blood glucose-lowering effects of ß-glucan from oats and barley depend on the amounts consumed and their rheological properties. This has been recently challenged with growing evidence that the food matrix may also be an important factor in predicting its physiological response. OBJECTIVE: The objective of this study was to examine the effects of varying doses of ß-glucan from oats and barley and added to a snack bar on postprandial glycemia. DESIGN: In a randomized crossover study, 12 healthy males and females consumed one of 8 snack bars containing 0 (control), 1.5, 3, and 6 g of ß-glucan derived from oats or barley or 3 white bread controls. All treatments contained 50 g of available carbohydrate. Blood glucose concentrations were measured after ingestion of the treatments over 2 hours. RESULTS: Incorporation of 1.5 to 6 g of ß-glucan into snack bars had no additional glucose-lowering benefits irrespective of dose and source compared to the control bars (0 g ß-glucan), suggesting that both the solid food matrix and composition of the bars may play a role in their effects on glycemic response. All bars reduced blood glucose area under the curve (AUC) by an average of 25% (p < 0.05) compared to the mean of the 3 white bread controls. CONCLUSION: Adding ß-glucan from oats and barley to the snack bar formulation used in this study did not yield any additional benefits beyond the glucose-lowering effects of the snack bars themselves.

When a placebo is not a 'placebo': a placebo effect on postprandial glycaemia.

AIMS: Placebo effects in clinical trials remain uncertain. To investigate a placebo effect on acute postprandial plasma glucose, we conducted a follow-up investigation on a previous study. METHODS: The effect of placebo (9 g encapsulated cornstarch +500 ml water, taken at -40 min) on the plasma glucose response to a 75-g oral glucose tolerance test (OGTT) was assessed in a previous study in 12 healthy subjects (gender, five male, seven female; age 27 +/- 6 years; body mass index 24 +/- 3.4 kg m(-2)). This was compared with the effect of a water control (500 ml water taken alone at -40 min) on the same outcome in the same subjects in a follow-up study. RESULTS: Cornstarch placebo decreased plasma glucose area under the curve during the 75-g OGTT by 28% [Delta (95% confidence interval) -63.3 min mmol(-1) l(-1) (-218.33, 91.66), P < 0.02] compared with the water control (P < 0.05). CONCLUSIONS: Postprandial plasma glucose outcomes may be vulnerable to placebo effects.

Beta-glucan from two sources of oat concentrates affect postprandial glycemia in relation to the level of viscosity.

OBJECTIVE: Soluble dietary fiber has been shown to attenuate the postprandial rise in blood glucose levels and reduce the risk of type 2 diabetes and cardiovascular disease. This effect seems to be related to its rheological properties including viscosity. We examined the intra-fiber variability between two different processing methods of concentrating beta-glucan from oats (aqueous vs. enzymatic) in relation to the level of viscosity of beta-glucan and its effect on postprandial glycemia in healthy individuals. DESIGN: In an acute, randomized, double-blind, crossover study, 11 healthy subjects (gender: 5M:6F; age: 34 +/- 5 years; BMI: 23 +/- 0.8 kg/m(2)) were randomly assigned, on three separate occasions, to consume one of three fiber-matched treatments along with a 75 g oral glucose drink. The enzymatically processed beta-glucan (Oat-A) differed from beta-glucan processed through the aqueous method (Oat-B) solely with regard to viscosity. Finger-prick capillary blood samples were obtained at fasting and at 15, 30, 45, 60, 90 and 120 min after the start of the test drink. The viscosities of the fiber drinks were determined (Paar Physica UDS200 viscometer). RESULTS: Rheological measurements demonstrated that Oat-A had a significantly higher viscosity than Oat-B and control at 5, 15, 30, 60, and 120 min (p < 0.001). The incremental area under the glucose curve (AUC) on Oat-A was 19.6% and 17% lower than that of Oat-B and control, respectively (p < 0.01). CONCLUSIONS: This study shows that processing oat beta-glucan through enzymatic, rather than by aqueous methods, preserves the viscosity and improves postprandial glycemic control.