scholarly journals The Effect of Arabinoxylan on Gastrointestinal Tolerance in Generally Healthy Adults: A Randomized, Placebo-Controlled, Crossover Study

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 304-304
Author(s):  
Oliver Chen ◽  
Traci Blonquist ◽  
Kristen Sanoshy ◽  
Kathleen Kelley ◽  
Eunice Mah
Keyword(s):  
Adverse Events ◽  
Stool Consistency ◽  
Double Blind ◽  
Glucose Levels ◽  
Severity Rating ◽  
Bowel Habits ◽  
Funding Sources ◽  
Gi Symptoms ◽  
Bowel Movements ◽  
Bristol Stool Scale

Abstract Objectives Arabinoxylan (AX) is a non-digestible carbohydrate composed of (1→4)-β-D-xylan polymers that contain arabinose and varying uronic acid residues. AX was formally identified as a dietary fiber by the U.S. FDA for its effect on maintenance of healthy blood glucose levels. The primary objectives of this human trial were to examine the effects of a novel prebiotic AX wheat fiber extract (87.9% AX) produced by upcycling crop leftovers, such as wheat straw, on gastrointestinal (GI) tolerance, bowel habits, and stool consistency in adults. Methods A randomized, double-blind, placebo-controlled, crossover trial with three test periods separated by 2-week washout periods was conducted. Forty-five subjects (M/F: 29/16, aged 47.8 ± 9.6 y, 27.9 ± 4.4 kg/m2) were randomly assigned to consume maltodextrin placebo (PLA) or AX wheat fiber extracts providing 6.37 g AX/d (LAX) or 12.74 g AX/d (HAX) for 3 weeks. Study products were mixed thoroughly with 16 oz. water and consumed twice a day, once each in the morning and evening, with or without food. During the 7 days prior to the start of any intervention (baseline) and prior to the end of each test period, GI symptoms, as well as bowel movement ratings and stool consistency and frequency, were evaluated using the GI Tolerability Questionnaire (GITQ), which assesses abdominal cramping, bloating, burping, flatulence, nausea, reflex, and stomach rumbling, and the Bowel Habits Diary with Bristol Stool Scale. Results There were no statistically significant differences between PLA, LAX, and HAX in the area under curve of the GITQ composite score, as well as severity rating of individual symptoms (P > 0.05). Additionally, stool frequency (median ranging 7.5–8.0 over 7 days), stool consistency (median ranging 3.71–3.84), straining during bowel movements, discomfort during bowel movements, and sensation of incomplete evacuation did not differ between interventions (P > 0.05). There were no reported adverse events that were judged to be related to the AX wheat fiber extract product. Conclusions Consumption of prebiotic AX wheat fiber extract product containing 6.37 or 12.74 g AX per day for 3 weeks did not affect GI tolerance symptom severity and bowel habits and stool consistency in adults and did not result in related adverse events, suggesting that the product is safe and well-tolerated. Funding Sources Comet Bio.

scholarly journals The Efficacy of Short-Duration Polyethylene Glycol plus Electrolytes for Improving Bowel Preparation of Colonoscopy in Patients with Chronic Constipation

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Naohisa Yoshida ◽  
Yoshikazu Inagaki ◽  
Kohei Fukumoto ◽  
Hiroyuki Yoriki ◽  
Yutaka Inada ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Adverse Events ◽  
Short Duration ◽  
Bowel Preparation ◽  
Chronic Constipation ◽  
Performance Status ◽  
Stool Consistency ◽  
Related Factors ◽  
Improvement Rate ◽  
Bowel Movements

Backgrounds and Aims. Sachets of polyethylene glycol plus electrolytes (PEG+E: Movicol: EA Pharma, Tokyo, Japan) are used for chronic constipation, and its efficacy is reported only for female and nonelderly people. Chronic constipation is one of the reasons of poor colonoscopic bowel preparation (BP). We analyzed its efficacy in improving chronic constipation and poor colonoscopic BP related to it, including male and elderly people. Materials and Methods. This multicenter retrospective study was conducted from September 2019 to September 2020 at 5 related institutions among patients ≥ 20 years old diagnosed with chronic constipation whose previous colonoscopic BP had had a fair or poor Aronchick score. Two or four sachets of PEG+E (13.7 or 27.4 g/day) were prescribed for 1 week before colonoscopy. We analyzed the rate of improvement in BP, effect-related factors, spontaneous bowel movements (SBMs), stool consistency, improvement of constipation symptoms, and adverse events. Results. We evaluated 106 cases (56 males) with an average age of 69.5 ± 9.4 years old (≤74 years old: 68 cases, ≥75 years old: 38 cases). The improvement rate of BP was 72.6%, and the insertion time and pain score also improved. A performance status of 1 or 2 was associated with poor BP. SBMs (times/week) increased from 4.0 ± 1.9 to 6.1 ± 2.6 ( p < 0.001 ). The overall improvement rates of SBMs, stool consistency, symptoms of constipation, and rate of adverse events were 58.5%, 90.6%, 59.4%, and 6.6%, respectively, showing no significant differences with regard to age or gender. Conclusions. Short-duration PEG+E was effective for improving poor BP and chronic constipation.

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 Improvement of defecation in healthy individuals with infrequent bowel movements through the ingestion of dried Mozuku powder: a randomized, double-blind, parallel-group study

2017 ◽  
Vol 7 (9) ◽  
pp. 735
Author(s):  
Masaki Matayoshi ◽  
Junjiro Teruya ◽  
Mina Yasumoto-Hirose ◽  
Ryuji Teruya ◽  
Naoki Miura ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Bowel Movement ◽  
Intestinal Function ◽  
Healthy Individuals ◽  
Double Blind ◽  
Blood Tests ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Bowel Movements

Background: Okinawa mozuku (Cladosiphon okamuranu) is a type of edible seaweed of the family Chordariaceae that typically contains the polysaccharide fucoidan as a functional ingredient. In Okinawa, raw mozuku is eaten as vinegared mozuku together with vinegar or as tempura (deep-fried in batter). Polysaccharides such as fucoidan are generally known to regulate intestinal function, which is why we have used Okinawa mozuku to investigate this intestinal regulatory effect.Methods: The study was designed as a randomized, double-blind, parallel group study. Dried Okinawa mozuku powder at a dose of 2.4 g/day (1.0 g/day of fucoidan) and a placebo not containing any dried Okinawa mozuku powder were each made into capsules and given to healthy men and women with infrequent weekly bowel movements (2–4 movements a week) to ingest for eight weeks. We then investigated changes in the defecation situation, blood tests, and adverse events. Results: In the group that ingested the capsules containing dried Okinawa mozuku powder, the number of days with a bowel movement significantly increased compared with the placebo group after four weeks of ingestion (p < 0.05). Furthermore, after eight weeks of ingestion, the same increasing trend was seen compared with the placebo group (p = 0.0964). The volume of stool also increased significantly in the dried Okinawa mozuku powder group after eight weeks compared with the placebo group. In terms of blood tests and adverse events, no adverse events occurred that were the result of the test food.Conclusions: Ingestion of Okinawa mozuku was found to have a regulatory effect on intestinal function by promoting defecation in healthy individuals with a tendency for constipation. This demonstrated that Okinawa mozuku is a functional food capable of making defecation smoother and increasing the volume of stool.Key Words: Okinawa mozuku, Cladosiphon okamuranus, fucoidan, dry powder, bowel movement, constipation

The Effect of Lactobacillus reuteri Supplementation in Adults with Chronic Functional Constipation: a Randomized, Double-Blind, Placebo-Controlled Trial*

2014 ◽  
Vol 23 (4) ◽  
pp. 387-391 ◽  
Author(s):  
Veronica Ojetti ◽  
Gianluca Ianiro ◽  
Annalisa Tortora ◽  
Giovanna D‘Angelo ◽  
Teresa Antonella Di Rienzo ◽  
...  
Keyword(s):  
Bowel Movement ◽  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Stool Consistency ◽  
Double Blind ◽  
Movement Frequency ◽  
Bowel Movements ◽  
Bowel Movement Frequency ◽  
The Mean

Background & Aims: There is a growing interest for the use of probiotics for chronic constipation. A recent randomized controlled trial (RCT) showed a positive effect of Lactobacillus reuteri (L. reuteri) on bowel movement frequency in infants with chronic constipation. The aim of the present study was to evaluate the effects of L. reuteri in adult patients with functional constipation.Methods: A double-blind, placebo RCT was conducted in 40 adults (18M/22F, 35±15 years) affected by functional constipation according to the Rome III criteria. Patients were randomly assigned to receive a supplementation of L. reuteri (DSM 17938), or matching placebo for 4 weeks. The increase of bowel movements/week was the primary outcome, while the improvement of stool consistency was the secondary outcome.Results: At week 4, the mean increase in bowel movements/week was 2.6 (SD±1.14, 95% CI:1.6-3.6) in the L. reuteri group and 1.0 (SD±1. 95% CI:0.12-1.88) in the placebo group (p=0.046). At the end of the treatment, the mean bowel movements/week was 5.28±1.93 in the L. reuteri group and 3.89±1.79 in the placebo group. There was a not significant difference in the stool consistency between the two groups.Conclusions: L. reuteri is more effective than the placebo in improving bowel movement frequency in adult patients with functional constipation as previously demonstrated in children, even if it seems to have no effect on stool consistency.

scholarly journals Effects of Blenderized Watermelon With the Rind on Satiety, Bowel Movement, and Postprandial Glucose

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 348-348
Author(s):  
Trisha Molina ◽  
Samantha Johansen ◽  
Timothy Nishimura ◽  
Martin Jr Rosas ◽  
Kristine Giltvedt ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Metabolic Diseases ◽  
Bowel Movement ◽  
Postprandial Glucose ◽  
Double Blind ◽  
Beneficial Effects ◽  
Glucose Levels ◽  
Watermelon Juice ◽  
Watermelon Rind ◽  
Bowel Movements

Abstract Objectives Many studies have examined the beneficial effects of watermelon flesh on metabolic diseases, yet fewer studies have investigated the effects of watermelon rind. While normally discarded, rind consumption not only reduces food waste but contains fiber (pectin) and healthful bioactive compounds such as citrulline. This study examined the effects of watermelon rind consumption on postprandial glucose, satiety and bowel movements. It was hypothesized that consumption of blenderized watermelon juice with rind would lower postprandial glucose, increase satiety and improve bowel movement habits. Methods In a double-blind randomized crossover study, 21 participants (age 26.3 ± 5.7 y, BMI 22.6 ± 2.8 kg/m2) consumed one cup (8 fl. oz) of blenderized watermelon juice with or without rind. A visual analogue scale was used to measure satiety at baseline, immediately after, 20, 40, 60 and 90 minutes post juice consumption. Blood glucose was measured at baseline, 20, 40, 60 and 90 minutes post juice consumption. Bowel movement questionnaires were administered two days before and after each trial. Results Both blenderized watermelon juices (with and without rind) increased satiety with more fullness in watermelon juice with rind (P &lt; 0.05). Watermelon juice with rind also stabilized blood glucose levels in comparison to watermelon juice (P &lt; 0.001). No significant differences between the two trials for bowel movements were found, but no evidence of constipation or discomfort was presented among the participants. Conclusions These results suggest that watermelon juice with rind has favorable effects on postprandial glucose and satiety levels but no effect on bowel movements. Therefore, further research into the benefits of watermelon rind is important and could offer potential clinical applications and disease prevention. Funding Sources NUTR 302L Advanced Nutrition Laboratory San Diego State University and National Watermelon Promotion Board (NWPB 19–20).

scholarly journals Effects of Saccharomyces cerevisiae NK-1 on stool frequency and volume in healthy individuals with infrequent bowel movements: a randomized, placebo, placebo controlled, double-blind study

2018 ◽  
Vol 8 (9) ◽  
pp. 462
Author(s):  
Ryuji Takeda ◽  
Norio Kanesugi ◽  
Michiyo Kanesugi ◽  
Syukuko Ebihara ◽  
Shigeru Imai
Keyword(s):  
Saccharomyces Cerevisiae ◽  
Adverse Events ◽  
Bowel Movement ◽  
Stool Frequency ◽  
Double Blind Study ◽  
Healthy Individuals ◽  
Double Blind ◽  
Test Food ◽  
Gastrointestinal Discomfort ◽  
Bowel Movements

Background: Constipation and other symptoms of gastrointestinal discomfort, such as abdominal swelling, are common among healthy individuals and have a significant impact on quality of life. Despite the known contribution of gut microbiomes to this pathology, little is known regarding which groups of microorganisms play a key role. Yeasts have been used for fermenting foods since ancient times. Saccharomyces cerevisiae is a type of yeast used for industrial and pharmaceutical purposes in the genetic and medical fields because it is unicellular with a simple biological structure. Yeast also helps improve the intestinal environment. The present study aimed to investigate the effect of foods containing Saccharomyces cerevisiae on bowel movement and to validate the safety of its long-term usage. Stool frequency and consistency were also assessed.Methods: This was a randomized, double-blind, parallel-group study. The test food contained S. cerevisiae NK-1 powder (1 × 1010 cells), whereas the placebo did not contain it. The food was made into sticks and provided to healthy individuals with infrequent bowel movements (3–5 movements a week), three times a day for 12 weeks. Then we investigated the changes in stool frequency, volume, and other adverse events. Results: The number of days with bowel movement significantly increased in the test group compared with the placebo group after 8–12 weeks of consuming the test food (p < 0.05). Based on the blood test results, there were no adverse events associated with the consumption of the test food observed.Conclusions: Consumption of the test food regulated intestinal function by promoting defecation in healthy individuals prone to constipation. Thus, S. cerevisiae NK-1 helps facilitate smoother defecation.Keywords: Saccharomyces cerevisiae NK-1, bowel movement, stool frequency volume, gastrointestinal discomfort

scholarly journals Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Egilius L. H. Spierings ◽  
Mikko Kärppä ◽  
Xiaoping Ning ◽  
Joshua M. Cohen ◽  
Verena Ramirez Campos ◽  
...  
Keyword(s):  
United States ◽  
Czech Republic ◽  
Adverse Events ◽  
Least Squares ◽  
The United States ◽  
Inadequate Response ◽  
Double Blind ◽  
Monthly Average ◽  
Preventive Medication ◽  
Subgroup Analyses

Abstract Background The FOCUS study evaluated the efficacy of migraine preventive medications across different countries within the same patient population, particularly for patients with difficult-to-treat migraine. These prespecified subgroup analyses evaluated efficacy by country in the FOCUS study of fremanezumab in adults with episodic migraine or chronic migraine and documented inadequate response to 2 to 4 migraine preventive medication classes. Methods Overall, 838 participants were enrolled in the FOCUS study, a randomized, double-blind, placebo-controlled, parallel-group, phase 3b study performed at 104 sites. For 12 weeks of double-blind treatment, patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched placebo. The primary efficacy endpoint was the mean change from baseline in monthly average migraine days over 12 weeks of double-blind treatment, evaluated by country in these subgroup analyses. Results Of 14 countries contributing data, the Czech Republic (n = 188/838; 22%), the United States (n = 120/838; 14%), and Finland (n = 85/838; 10%) enrolled the most patients. Changes from baseline in monthly average migraine days over 12 weeks were significantly greater with fremanezumab versus placebo for patients in these countries: Czech Republic (least-squares mean difference versus placebo [95% confidence interval]: quarterly fremanezumab, − 1.9 [− 3.25, − 0.47]; P = 0.009; monthly fremanezumab, − 3.0 [− 4.39, − 1.59]; P < 0.001), the United States (quarterly fremanezumab, − 3.7 [− 5.77, − 1.58]; P < 0.001; monthly fremanezumab, − 4.2 [− 6.23, − 2.13]; P < 0.001), and Finland (quarterly fremanezumab, − 3.0 [− 5.32, − 0.63]; P = 0.014; monthly fremanezumab, − 3.9 [− 6.27, − 1.44]; P = 0.002). Results were comparable for the remaining 9 countries, with the least-squares mean difference versus placebo ranging from – 5.6 to – 2.4 with quarterly fremanezumab and from − 5.3 to − 1.5 with monthly fremanezumab. Incidences of serious adverse events and adverse events leading to discontinuation were low and comparable across countries and treatment groups. Conclusions Monthly and quarterly fremanezumab significantly reduced the monthly average number of migraine days versus placebo regardless of country and continent (North America versus Europe) in migraine patients with documented inadequate response to 2 to 4 migraine preventive medication classes. Trial registration ClinicalTrials.gov Identifier: NCT03308968.

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