scholarly journals Gastrointestinal effects of resistant starch, soluble maize fibre and pullulan in healthy adults

2013 ◽  
Vol 110 (6) ◽  
pp. 1068-1074 ◽  
Author(s):  
Abby S. Klosterbuer ◽  
Meredith A. J. Hullar ◽  
Fei Li ◽  
Elizabeth Traylor ◽  
Johanna W. Lampe ◽  
...  
Keyword(s):  
Resistant Starch ◽  
Human Subjects ◽  
Healthy Adults ◽  
Significant Shift ◽  
Gut Health ◽  
Healthy Human ◽  
Double Blind ◽  
Gi Symptoms ◽  
And Control ◽  
Gut Microbial Community

Fibre has been shown to exert a number of benefits on gastrointestinal (GI) health, yet its intake is low. Addition of novel fibres to food products may increase fibre intake and improve gut health. The objective of the present study was to evaluate the influence of three novel fibres on GI outcomes in healthy human subjects. A total of twenty healthy participants (ten men and ten women) with normal BMI (23 (sem 2) kg/m2) participated in the present randomised, double-blind, cross-over study with five treatment periods. Participants consumed a maltodextrin control or 20–25 g/d fibre from soluble maize fibre (SCF) or resistant starch (RS), alone or in combination with pullulan (SCF+P and RS+P). The treatment periods were 7 d with a 3-week washout between the periods. Stool samples were collected on day 7 of each period, and GI tolerance was assessed via a questionnaire on days 1 and 6. There were no treatment differences in stool weight or consistency. SCF significantly reduced stool pH and increased total SCFA production compared with RS and control. RS+P significantly increased the percentage of butyrate compared with all the other treatments. Overall, GI symptoms were minimal. SCF+P led to the highest GI score on day 1, while RS+P had the highest score on day 6. Both SCF treatments caused a significant shift in the gut microbial community. These functional fibres are generally well tolerated, have minimal effects on laxation and may lead to beneficial changes in SCFA production in healthy adults.

Consumption by Healthy Adults of Pasteurized Milk with a High Concentration of Bacillus cereus: A Double-Blind Study

1996 ◽  
Vol 59 (7) ◽  
pp. 723-726 ◽  
Author(s):  
LEO P. M. LANGEVELD ◽  
WILLEM A. VAN SPRONSEN ◽  
EMERENTIA C. H. VAN BERESTEIJN ◽  
SERVÉ H. W. NOTERMANS
Keyword(s):  
Bacillus Cereus ◽  
Healthy Adults ◽  
Double Blind Study ◽  
High Concentration ◽  
Healthy Human ◽  
Double Blind ◽  
Pasteurized Milk ◽  
Human Volunteers ◽  
Pure Cultures ◽  
Gastrointestinal Complaints

A double-blind experiment with 34 healthy human volunteers, aged between 20 and 60 years, was conducted to obtain information about the allowable concentration of B. cereus in pasteurized milk. During a period of 3 weeks the subjects were exposed to B. cereus naturally present in pasteurized milk following storage for 3 to 14 days at 7.5°C. Of 259 milk exposures, gastrointestinal complaints were observed in 18 cases. According to total numbers of B. cereus ingested per exposure the complaints per number of exposures were distributed as follows: < 106: 5 in 132; 106 to 107: 2 in 32; 107 to 108 : 2 in 26; and > 108: 9 in 69. Symptoms, however, were not typical of those caused by B. cereus. There was a weak significance (P ≤ 0.1) for symptoms when > 108 B. cereus cells were ingested. Milk with 106 to 107 B. cereus cells per ml showed a very low diarrheal enterotoxin titer. Pure cultures of B. cereus strains isolated from samples with high B. cereus concentrations also showed a low production of enterotoxin. It can be concluded that for healthy adults the probability of become diseased from cold-stored pasteurized milk is small. From the results no evidence is obtained that B. cereus concentrations less than 105/ml will cause intoxication.

Selective effects of serotonergic psychoactive agents on gastrointestinal functions in health

2003 ◽  
Vol 284 (1) ◽  
pp. G130-G137 ◽  
Author(s):  
Heather J. Chial ◽  
Michael Camilleri ◽  
Duane Burton ◽  
George Thomforde ◽  
Kevin W. Olden ◽  
...  
Keyword(s):  
Reuptake Inhibitor ◽  
Human Subjects ◽  
Functional Gastrointestinal Disorders ◽  
Gastric Volume ◽  
Colonic Transit ◽  
Selective Serotonin ◽  
Healthy Human ◽  
Double Blind ◽  
Solid Meal ◽  
Healthy Humans

This study evaluated the effects of serotonergic psychoactive agents on gastrointestinal functions in healthy human subjects. Participants received one of four regimens in a randomized, double-blind manner: buspirone, a 5-HT1Areceptor agonist (10 mg twice daily); paroxetine, a selective serotonin reuptake inhibitor (20 mg daily); venlafaxine-XR, a selective serotonin and norepinephrine reuptake inhibitor (75 mg daily); or placebo for 11 days. Physiological testing performed on days 8–11included scintigraphic assessment of gastrointestinal and colonic transit, the nutrient drink test, and assessment of the postprandial change in gastric volume. Fifty-one healthy adults (40 females, 11 males) participated in this study. No effects on gastric emptying or colonic transit were identified with any agent. Small bowel transit of a solid meal was accelerated by paroxetine. Buspirone decreased postprandial aggregate symptom and nausea scores. Venlafaxine-XR increased the postprandial change in gastric volume. Buspirone, paroxetine, and venlafaxine-XR affect upper gastrointestinal functions in healthy humans. These data support the need for clinical and physiological studies of these agents in functional gastrointestinal disorders.

scholarly journals Postprandial Glucose and Insulin Response to a Cookie with or Without Added RS4 Wheat Starch After 3 Days of Pre-Feeding: A Double Blind, Randomized, Controlled Clinical Trial (P08-081-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Alexandra Jenkins ◽  
Clodualdo Maningat ◽  
Paul Seib ◽  
Janice Campbell ◽  
Adish Ezatagha ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Resistant Starch ◽  
Healthy Subjects ◽  
Postprandial Glucose ◽  
Wheat Starch ◽  
Feeding Period ◽  
Double Blind ◽  
Blood Samples ◽  
Glucose Levels ◽  
Gi Symptoms

Abstract Objectives Research on the effect of resistant starch on postprandial glucose levels has mainly focused on the attenuation achieved by substituting it for the available carbohydrate (avCarb), few studies have looked at the effect on glucose levels when the resistant starch is added to avCarb. The objective of this study was therefore to investigate the acute effect on postprandial glycemia and insulinemia of a cross-linked RS4 wheat starch (Fibersym® RW) in a test cookie compared to a control cookie matched for available carbohydrate after a 3-day habituation period. Methods This study used a double blind, randomized, cross-over design. Nineteen healthy subjects were screened of which 16 were eligible and randomized into the study. A total of 15 subjects completed the study (5M:10F; 32 ± 11y; 24.9 ± 2.5 kg/m2; BP 112/70 mmHg). After 3-day pre-feeding of Control (dietary fiber 1.6 g/d) or Fibersym sugar snap cookies (dietary fiber 29 g/d), the subjects, after an overnight fast, consumed either the respective Control or Fibersym cookie, both meals contained 40 g avCarb. Blood samples were collected over 2 h. Gastrointestinal (GI) symptoms were recorded during the pre-feeding period and during the postprandial visit. Subjective appetite scores were measured at the same time points when blood samples were collected. Results The 90-min blood glucose incremental area under the curve (IAUC) was statistically significantly lower after ingesting the Fibersym cookie (71.9 ± 8.5 mmolxmin/L) compared to the Control cookie (86.7 ± 9.3 mmolxmin/L) (P < 0.02). In addition, the peak glucose concentrations at 30 and 45 min after consumption of the Fibersym cookie was significantly lower than the Control cookie (P < 0.05). Insulin levels at 90-min (P < 0.016) and the 2-h (P < 0.02) insulin IAUC's were significantly lower after consumption of the Fibersym cookie compared to the Control cookie. There were no significant differences in GI symptoms over the 3-day pre-feeding period and during the 2 h postprandial visit between the two cookies and neither did the appetite scores differ significantly. Conclusions The cross-linked RS4 wheat starch, Fibersym, when formulated into a cookie, is well tolerated and attenuates blood glucose and insulin levels in healthy subjects compared to a Control cookie containing the same amount of available carbohydrate. Funding Sources MGP Ingredients, Inc.

scholarly journals Consuming foods with added oligofructose improves stool frequency: a randomised trial in healthy young adults

2014 ◽  
Vol 3 ◽  
Author(s):  
Wendy J. Dahl ◽  
Arnelle R. Wright ◽  
Gretchen J. Specht ◽  
Mary Christman ◽  
Anne Mathews ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Healthy Adults ◽  
Stool Frequency ◽  
Online Questionnaire ◽  
Double Blind ◽  
Fibre Intake ◽  
Intensity Score ◽  
Gi Symptoms ◽  
Symptom Intensity ◽  
The Impact

AbstractThe impact of oligofructose (OF) intake on stool frequency has not been clearly substantiated, while significant gastrointestinal (GI) symptoms have been reported in some individuals. The aim of the present study was to determine the effects of OF on stool frequency and GI symptoms in healthy adults. In an 8-week, randomised, double-blind, parallel-arm study, ninety-eight participants were provided with 16 g OF in yogurt and snack bars (twenty male and thirty female) or matching control foods (seventeen male and thirty-one female), to incorporate, by replacement, into their usual diets. Participants completed a daily online questionnaire recording stool frequency and rating four symptoms: bloating, flatulence, abdominal cramping and noise, each on a Likert scale from ‘0’ for none (no symptoms) to ‘6’ for very severe, with a maximum symptom intensity score of 24 (sum of severities from all four symptoms). Online 24 h dietary recalls were completed during pre-baseline and weeks 4, 6 and 8 to determine fibre intake. When provided with OF foods, fibre intake increased to 24·3 (sem 0·5) g/d from pre-baseline (12·1 (sem 0·5) g/d; P < 0·001). Stool frequency increased with OF from 1·3 (sem 0·2) to 1·8 (sem 0·2) stools per d in males and 1·0 (sem 0·1) to 1·4 (sem 0·1) stools per d in females during intervention weeks compared with pre-baseline (P < 0·05),but did not change for control participants (males: 1·6 (sem 0·2) to 1·8 (sem 0·2); females: 1·3 (sem 0·1) to 1·4 (sem 0·1)). Flatulence was the most commonly reported symptom. Mean GI symptom intensity score was higher for the OF group (3·2 (sem 0·3)) v. control (1·7 (sem 0·1)) (P < 0·01), with few participants reporting above moderate symptoms. No change in symptom intensity occurred over time. Consuming yogurt and snack bars with 16 g OF improves regularity in young healthy adults. However, GI symptoms, resulting from an increase in oligofructose intake, may not diminish with time.

scholarly journals Phaseolus vulgaris extract affects glycometabolic and appetite control in healthy human subjects

2012 ◽  
Vol 109 (10) ◽  
pp. 1789-1795 ◽  
Author(s):  
Angela Spadafranca ◽  
Samuele Rinelli ◽  
Antonella Riva ◽  
Paolo Morazzoni ◽  
Paolo Magni ◽  
...  
Keyword(s):  
Phaseolus Vulgaris ◽  
Human Subjects ◽  
Postprandial Glucose ◽  
Controlled Study ◽  
Appetite Control ◽  
Healthy Human ◽  
Double Blind ◽  
C Peptide ◽  
Ghrelin Secretion ◽  
Desire To Eat

Extracts of Phaseolus vulgaris (beans) are known to reduce glycaemia and food intake in rodents and humans. The present study evaluated the effects of a new, standardised and purified P. vulgaris extract (PVE), when employed as a supplement in a mixed balanced meal (60 % carbohydrates, 25 % lipids and 15 % protein), on glycometabolic and appetite control. To this end, a randomised, double-blind, placebo-controlled study was performed in twelve volunteers. Plasma glucose, insulin, C-peptide, ghrelin and satiety sensation ratings were assessed at baseline and during 3 h after meal consumption associated with PVE (100 mg) or placebo. Compared with placebo, PVE consumption resulted in lower increments in glucose (+15·4 (sem 5·4) v. 26·1 (sem 7·3) %, P= 0·04 at 30 min), insulin (+981 (sem 115) v. 1325 (sem 240) %, P= 0·04 between 45 and 120 min) and C-peptide (+350 (sem 27) v. 439 (sem 30) %, P= 0·04 between 30 and 90 min). In the first 2 h, plasma ghrelin decreased similarly in both groups but did not rebound as in placebo thereafter (P= 0·04). Correspondingly, satiety sensation in the third hour was significantly reduced in the placebo but not in the PVE condition. PVE induced a lower desire to eat than placebo (P= 0·02) over the 3 h. In conclusion, PVE supplementation reduced postprandial glucose, insulin and C-peptide excursions, suppressed ghrelin secretion and affected satiety sensations, inducing a lower desire to eat. These results support that further studies are needed to prove the concept of employing PVE as a supplement in mixed balanced meals in obese, glucose-intolerant and diabetic subjects.

First in human trial of a type I positive allosteric modulator of alpha7-nicotinic acetylcholine receptors: Pharmacokinetics, safety, and evidence for neurocognitive effect of AVL-3288

2017 ◽  
Vol 31 (4) ◽  
pp. 434-441 ◽  
Author(s):  
Kelvin W Gee ◽  
Ann Olincy ◽  
Richard Kanner ◽  
Lynn Johnson ◽  
Derk Hogenkamp ◽  
...  
Keyword(s):  
Nicotinic Acetylcholine Receptors ◽  
Nicotinic Receptor ◽  
Human Subjects ◽  
Receptor Activation ◽  
Auditory Evoked Potential ◽  
Type I ◽  
Healthy Human ◽  
Double Blind ◽  
Alpha7 Nicotinic Receptor ◽  
Neurocognitive Effect

Type I positive allosteric modulators (PAMs) of the alpha7-nicotinic receptor enhance its cholinergic activation while preserving the spatiotemporal features of synaptic transmission and the receptor’s characteristic rapid desensitization kinetics. Alpha7-nicotinic receptor agonists have shown promise for improving cognition in schizophrenia, but longer-term trials have been disappointing. Therefore, the type I PAM AVL-3288 was evaluated for safety and preliminary evidence of neurocognitive effect in healthy human subjects. Single-dose oral administration in ascending doses was conducted in a double-blind, placebo-controlled Phase I trial in non-smokers. The trial found indication of positive but non-significant effects on neurocognition at 10 and 30 mg, two doses that produced overlapping peak levels. There was also some evidence for effects on inhibition of the P50 auditory evoked potential to repeated stimuli, a biomarker that responds to alpha7-nicotinic receptor activation. The pharmacokinetic characteristics were consistent between subjects, and there were no safety concerns. The effects and safety profile were also assessed at 3 mg in a cohort of smokers, in whom concurrent nicotine administration did not alter either effects or safety. The trial demonstrates that a type I PAM can be safely administered to humans and that it has potential positive neurocognitive effects in central nervous system (CNS) disorders.

scholarly journals A randomised, double- blind, cross-over study investigating the prebiotic effect of agave fructans in healthy human subjects

2015 ◽  
Vol 4 ◽  
Author(s):  
P. Ramnani ◽  
A. Costabile ◽  
A. G. R. Bustillo ◽  
G. R. Gibson
Keyword(s):  
Denaturing Gradient Gel Electrophoresis ◽  
Human Subjects ◽  
Secretory Iga ◽  
Healthy Human ◽  
Double Blind ◽  
Bacterial Populations ◽  
Healthy Human Subjects ◽  
Gradient Gel Electrophoresis

AbstractThis placebo-controlled, randomised, double-blind, cross-over human feeding study aimed to determine the prebiotic effect of agave fructans. A total of thirty-eight volunteers completed this trial. The treatment consisted of 3 weeks' supplementation with 5 g/d of prebiotic agave fructan (Predilife) or equivalent placebo (maltodextrin), followed by a 2-week washout period following which subjects were crossed over to alternate the treatment arm for 3 weeks followed by a 2-week washout. Faecal samples were collected at baseline, on the last day of treatment (days 22 and 58) and washout (days 36 and 72), respectively. Changes in faecal bacterial populations, SCFA and secretory IgA were assessed using fluorescentin situhybridisation, GC and ELISA, respectively. Bowel movements, stool consistencies, abdominal comfort and mood changes were evaluated by a recorded daily questionnaire. In parallel, the effect of agave fructans on different regions of the colon using a three-stage continuous culture simulator was studied. Predilife significantly increased faecal bifidobacteria (log109·6 (sd0·4)) and lactobacilli (log107·7 (sd0·8)) compared with placebo (log109·2 (sd0·4);P = 0·00) (log107·4 (sd0·7);P= 0·000), respectively. No change was observed for other bacterial groups tested, SCFA, secretory IgA, and PGE2concentrations between the treatment and placebo. Denaturing gradient gel electrophoresis analysis indicated that bacterial communities were randomly dispersed and no significant differences were observed between Predilife and placebo treatments. Thein vitromodels showed similar increases in bifidobacterial and lactobacilli populations to that observed with thein vivotrial. To conclude, agave fructans are well tolerated in healthy human subjects and increased bifidobacteria and lactobacilli numbersin vitroandin vivobut did not influence other products of fermentation.

Double-Blind, Placebo-Controlled, Randomized Clinical Trial of the Effect of the Dietary Supplement S-Adenosyl-L-Methionine (AdoMet) on Plasma Homocysteine (Hcy) Levels in Healthy Human Subjects.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 1481-1481
Author(s):  
Michael A. Thompson ◽  
Brent A. Bauer ◽  
Laura L. Loehrer ◽  
Stephen S. Cha ◽  
Jayawant N. Mandrekar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Randomized Clinical Trial ◽  
Primary Endpoint ◽  
Human Subjects ◽  
Nutritional Supplement ◽  
Healthy Human ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Healthy Human Subjects

Abstract BACKGROUND: S-adenosyl-L-methionine (AdoMet or SAM-e®) is a commonly used nutritional supplement available in the United States since 1999. AdoMet is metabolized to homocysteine (Hcy), a potential cardiovascular risk factor. A few open-label, single-arm studies have reported on the effect of exogenous AdoMet on the levels of Hcy in humans; however, this has not been tested in a double-blind, randomized clinical trial. As a nutritional supplement, AdoMet is subject only to limited regulation by the FDA, despite being used to treat clinical diseases such as depression and osteoarthritis. AdoMet is the methyl donor for small molecule, DNA, RNA, and protein methylation reactions; therefore, further understanding the biology of the AdoMet/Hcy system is important. We hypothesized that exogenous AdoMet would increase plasma Hcy levels. METHODS: In a double-blind, placebo-controlled, randomized clinical trial, 93 healthy human subjects were screened and 52 were treated with placebo (26) or 800 mg per day AdoMet (26) pills for 4 weeks. Pre- and post-treatment Hcy levels were measured. The primary endpoint was change in Hcy level. Secondary endpoints included an interim Hcy level, high sensitivity C-reactive protein (hsCRP) levels, lipid profile, and transaminases. Exclusion criteria included pregnancy and concurrent use of medications associated with changes in Hcy. RESULTS: Of 52 subjects enrolled, 45 were evaluable at the end of treatment. Subject characteristics and dropout rates were similar between placebo and control groups. Adverse events were minor and were not different between placebo and AdoMet. The primary endpoint, change in Hcy, was not significantly different between the groups (mean (umol/L), baseline: 7.43 (placebo), 8.25 (AdoMet), P=0.358; 4 week: 7.66 (placebo), 8.06 (AdoMet), P = 0.683; Baseline − 4 week: 0.23 (placebo), −0.19 (AdoMet), P = 0.427). No statistically significant difference in change in Hcy or hsCRP at 2 or 4 weeks was noted. This was true for both absolute differences as well as relative percent changes. A small decrease in ALT was observed at 2 weeks in the AdoMet group compared to the placebo group (P = 0.027). AdoMet is used in the treatment of liver diseases. There was a small, but statistically significant (P = 0.028) decrease in total cholesterol in the AdoMet group as compared to the placebo group. Interestingly, a subject with the highest baseline Hcy level had a decline in Hcy on AdoMet. Study limitations include no evaluation of AdoMet serum levels or measurement of the effect of AdoMet on DNA methylation patterns. CONCLUSIONS: AdoMet seems well tolerated and in a dose of 800 mg/day for 4 weeks does not appear to significantly affect Hcy levels in the blood. Future clinical trials of AdoMet should monitor Hcy levels with extended use of AdoMet to confirm its safety with long term use. Clinicaltrials.gov ID: NCT00284011.

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