scholarly journals Impact of polydextrose on the faecal microbiota: a double-blind, crossover, placebo-controlled feeding study in healthy human subjects

2011 ◽  
Vol 108 (3) ◽  
pp. 471-481 ◽  
Author(s):  
Adele Costabile ◽  
Francesca Fava ◽  
Henna Röytiö ◽  
Sofia D. Forssten ◽  
Kaisa Olli ◽  
...  
Keyword(s):  
Human Subjects ◽  
Microbial Composition ◽  
Healthy Human ◽  
Double Blind ◽  
Feeding Study ◽  
Bowel Habits ◽  
Immune Parameters ◽  
Microbial Groups ◽  
The Impact

In this placebo-controlled, double-blind, crossover human feeding study, the effects of polydextrose (PDX; 8 g/d) on the colonic microbial composition, immune parameters, bowel habits and quality of life were investigated. PDX is a complex glucose oligomer used as a sugar replacer. The main goal of the present study was to identify the microbial groups affected by PDX fermentation in the colon. PDX was shown to significantly increase the known butyrate producerRuminococcus intestinalisand bacteria of theClostridiumclusters I, II and IV. Of the other microbial groups investigated, decreases in the faecalLactobacillus–Enterococcusgroup were demonstrated. Denaturing gel gradient electrophoresis analysis showed that bacterial profiles between PDX and placebo treatments were significantly different. PDX was shown to be slowly degraded in the colon, and the fermentation significantly reduced the genotoxicity of the faecal water. PDX also affected bowel habits of the subjects, as less abdominal discomfort was recorded and there was a trend for less hard and more formed stools during PDX consumption. Furthermore, reduced snacking was observed upon PDX consumption. This study demonstrated the impact of PDX on the colonic microbiota and showed some potential for reducing the risk factors that may be associated with colon cancer initiation.

scholarly journals A double-blind, placebo-controlled, cross-over study to establish the bifidogenic effect of a very-long-chain inulin extracted from globe artichoke (Cynara scolymus) in healthy human subjects

2010 ◽  
Vol 104 (7) ◽  
pp. 1007-1017 ◽  
Author(s):  
Adele Costabile ◽  
Sofia Kolida ◽  
Annett Klinder ◽  
Eva Gietl ◽  
Michael Bäuerlein ◽  
...  
Keyword(s):  
Gastrointestinal Symptoms ◽  
Gas Production ◽  
Globe Artichoke ◽  
Daily Consumption ◽  
Healthy Human ◽  
Double Blind ◽  
Cynara Scolymus ◽  
The Impact ◽  
Long Chain

There is growing interest in the use of inulins as substrates for the selective growth of beneficial gut bacteria such as bifidobacteria and lactobacilli because recent studies have established that their prebiotic effect is linked to several health benefits. In the present study, the impact of a very-long-chain inulin (VLCI), derived from globe artichoke (Cynara scolymus), on the human intestinal microbiota compared with maltodextrin was determined. A double-blind, cross-over study was carried out in thirty-two healthy adults who were randomised into two groups and consumed 10 g/d of either VLCI or maltodextrin, for two 3-week study periods, separated by a 3-week washout period. Numbers of faecal bifidobacteria and lactobacilli were significantly higher upon VLCI ingestion compared with the placebo. Additionally, levels ofAtopobiumgroup significantly increased, whileBacteroides–Prevotellanumbers were significantly reduced. No significant changes in faecal SCFA concentrations were observed. There were no adverse gastrointestinal symptoms apart from a significant increase in mild and moderate bloating upon VLCI ingestion. These observations were also confirmed byin vitrogas production measurements. In conclusion, daily consumption of VLCI extracted from globe artichoke exerted a pronounced prebiotic effect on the human faecal microbiota composition and was well tolerated by all volunteers.

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

scholarly journals Wine preferences based on intrinsic attributes: A tasting experiment in Alto Adige/Südtirol province

2021 ◽  
pp. 129-134
Author(s):  
Luigi Fabbris ◽  
Alfonso Piscitelli
Keyword(s):  
Food Product ◽  
Fractional Factorial ◽  
Region Of Origin ◽  
Double Blind ◽  
White Wines ◽  
Grape Varieties ◽  
The Impact ◽  
Administration Procedure ◽  
Selection Of

Different methods have been developed by researchers in modelling wine consumers purchase behaviour. The quality of a food product is described by a set of characteristics ascribable to the intrinsic and extrinsic product attributes (Olson and Jacoby, 1972). Price, brand, region of origin, grapes and gained awards are the key extrinsic attributes and physical characteristics of the wine such as taste and flavour are intrinsic attributes. This paper addresses the problem of measuring the intrinsic attributes that characterise the wine, based on specific characteristics and the impact on consumers in terms of preferences. To this end, a fractional factorial experiment held on a selection of white wines of the Alto Adige/Südtirol province in Italy. The sensorial experiment involved a voluntary sample of 33 mild wine consumers and concerned 6 grape varieties typical of that territory. For each variety, two producing cellars were selected for a total of 12 evaluated wines. The experiment followed a double-blind administration procedure to the sample and a paper questionnaire was used to elicit the consumers’ opinions on the tasted wines. The results show that intrinsic attributes, such as taste-olfactory intensity, harmony and olfactory complexity, are the drivers used in combination by consumers to rank wines in order of preference.

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 Insomnia and Quality of Life in Generalized Anxiety Disorder: Impact on Clinical Presentation and Response to Pregabalin and Venlafaxine-XR

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
M.A. Mychaskiw ◽  
J.M. Alvir ◽  
B.K. Herman ◽  
S. Pallanti ◽  
A. Joshi
Keyword(s):  
Quality Of Life ◽  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Sleep Problems ◽  
Generalized Anxiety ◽  
Medical Outcomes ◽  
Double Blind ◽  
Disturbance Factor ◽  
The Impact

Aims:To assess the impact of insomnia on quality of life (QoL) and functioning in patients with generalized anxiety disorder (GAD), and evaluate the efficacy of pregabalin and venlafaxine-XR in improving sleep and QoL.Methods:A double-blind trial in adults who met DSM-IV criteria for GAD, with a HAM-A total score ≥20,randomized to 8-weeks of flexible-dose treatment with pregabalin (300-600 mg/d, N=121), venlafaxine-XR (75-225 mg/d, N=125), or placebo (N=128).Results:At baseline, 64% of all subjects had insomnia (according to the Medical Outcomes Study Sleep scale [MOS]-Sleep Problems Index [SPI] criteria).While HAM-A total scores (minus the insomnia item) were similar for patients with and without baseline insomnia (25.7 vs. 25.0) those with reported significantly more impairment on the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q; 45.4 vs. 53.6; p< 0.0001) and Sheehan Disability Scale (SDS; 17.5 vs.14.3; p< 0.0001) than those without. At endpoint, there was a significantly greater mean improvement in MOS-sleep disturbance factor and MOS-SPI with pregabalin (-29.0 and -21.1, respectively) than venlafaxine-XR (-14.7 and -11.0) or placebo (-15.2 and -12.5; all p< 0.05). In more pregabalin (64%) than venlafaxine-XR (51%) or placebo (52%) subjects, abnormal baseline sleep had normalized by endpoint. Endpoint change in MOS-SPI significantly correlated with improvement in both Q-LES-Q and SDS-total scores (Spearman r-values, -0.48 and 0.46, respectively; both p< 0.0001; all subjects).Conclusion:Significantly greater impairment in QoL and functioning was observed in patients with high (vs. low) levels of insomnia. Pregabalin produced significantly greater improvement in insomnia than venlafaxine-XR or placebo.

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair - The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already showed the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and quality of life at mid- and long-term before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical scale of pain (ENS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show a 30% reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. Ropivacaine was a promising candidate drug, inexpensive, easy to administer, and easy to add on the routine management of deliveries in labor ward.

scholarly journals The efficacy and safety of feverfew (Tanacetum parthenium L.): an update of a systematic review

2000 ◽  
Vol 3 (4a) ◽  
pp. 509-514 ◽  
Author(s):  
E Ernst ◽  
MH Pittler
Keyword(s):  
Systematic Review ◽  
Herbal Remedy ◽  
Human Subjects ◽  
Cochrane Library ◽  
Double Blind ◽  
Safety Issues ◽  
Tanacetum Parthenium ◽  
Literature Searches ◽  
The Cochrane Library

AbstractObjectiveFeverfew (Tanacetum parthenium L.) is a popular herbal remedy often advocated for the prevention of migraine. The aims of this systematic review are to update the evidence from rigorous clinical trials for or against the efficacy of feverfew for migraine prevention and to provide a safety profile of this herbal remedy.DesignLiterature searches were performed using the following databases: Medline, Embase, Biosis, CISCOM and the Cochrane Library (all from their inception to December 1999). Only randomized, placebo-controlled, double-blind trials of feverfew mono-preparations for the prevention of migraine in human subjects were included. All articles were read by two independent reviewers. Data were extracted in a pre-defined, standardized fashion. The methodological quality of the trials was evaluated by the Jadad score. For the assessment of safety issues, major reference texts were also consulted.ResultsSix trials met the inclusion/exclusion criteria. The majority favour feverfew over placebo. Yet important caveats exist. The data also suggest that feverfew is associated with only mild and transient adverse effects and few other safety concerns.ConclusionsFeverfew is likely to be effective in the prevention of migraine. There are no major safety problems.

Does biomarker information impact patients’ preferences for therapy?

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6527-6527
Author(s):  
Ann H. Partridge ◽  
Karen Sepucha ◽  
Anne O'Neill ◽  
Kathy Miller ◽  
Emily Baker ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Preference ◽  
Treatment Preferences ◽  
Double Blind Trial ◽  
Double Blind ◽  
Increased Risk ◽  
The Impact ◽  
To Receive

6527 Background: Biomarker information can risk stratify patients based on potential for benefits/toxicity from therapy. Ideally, a biomarker will identify those who benefit with limited toxicity. However, the impact of biomarkers is unclear when indicting individuals with greatest benefit are also at increased risk for toxicity. Methods: We surveyed participants at 18 month follow-up in the Decision-Making/Quality of Life (DM-QOL) component of ECOG5103, a RCT where patients were randomized to receive adjuvant chemotherapy for breast cancer with either placebo or bevacizumab (in 2 schedules). We asked patients for the preferred treatment in two hypothetical scenarios: 1) preference for chemo A or chemo A + B without biomarker information; 2) preference for chemo A or chemo A+B when participants tested positive for a “B-receptor” which increased both the benefit and toxicity of chemo A+B. McNemar’s test was used to examine changes in preferences. Results: 439 patients completed both scenarios on 18-month survey. The Table shows the treatment preferences in each scenario. The positive biomarker information in scenario 2 led 60/439 (14%) participants to switch their preference. The main reason for treatment preference in scenario 2 was greater benefits of chemo A+B (64%), the lower risks with chemo A (20%) and positive biomarker (10%). Among participants who changed preference, those randomized to receive bevacizumab were more likely to switch to chemo A in scenario 2. Conclusions: Information about a positive biomarker, indicating increased benefit and increased risk from additional chemo, did not significantly change participants’ preferred treatment. All participants were involved in a large placebo controlled double blind trial and the majority (70%) preferred the most aggressive course of treatment in both scenarios. Whether patients not enrolled in the trial would be more sensitive to the increased risk information is unclear. [Table: see text]

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.

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