scholarly journals Gastrointestinal Tolerance of D-Allulose in Healthy and Young Adults. A Non-Randomized Controlled Trial

Nutrients ◽  
2018 ◽  
Vol 10 (12) ◽  
pp. 2010 ◽  
Author(s):  
Youngji Han ◽  
Bo Choi ◽  
So Kim ◽  
Seong-Bo Kim ◽  
Yang Kim ◽  
...  

D-allulose has recently received attention as a sugar substitute. However, there are currently no reports regarding its association with gastrointestinal (GI) tolerance. Thus, we performed a GI tolerance test for D-allulose in order to establish its daily acceptable intake level. When the dose of D-allulose was gradually increased in steps of 0.1 g/kg·Body Weight (BW) to identify the maximum single dose for occasional ingestion, no cases of severe diarrhea or GI symptoms were noted until a dose of 0.4 g/kg·BW was reached. Severe symptoms of diarrhea were noted at a dose of 0.5 g/kg·BW. Similarly, the GI tolerance test did not show any incidences of severe diarrhea or GI symptoms until a dose of 0.5 g/kg·BW was reached. A correlation analysis of the GI tolerance test for D-allulose and sugar revealed significantly higher frequencies of symptoms of diarrhea (p = 0.004), abdominal distention (p = 0.039), and abdominal pain (p = 0.031) after D-allulose intake. Increasing the total daily D-allulose intake gradually to 1.0 g/kg·BW for regular ingestion resulted in incidences of severe nausea, abdominal pain, headache, anorexia, and diarrheal symptoms. Based on these results, we suggest a maximum single dose and maximum total daily intake of D-Allulose of 0.4 g/kg·BW and 0.9 g/kg·BW, respectively.


2021 ◽  
Vol 14 ◽  
pp. 175628482110217
Author(s):  
Hang Yang ◽  
Honglin Chen ◽  
Bing Hu

Background: Centrally mediated abdominal pain syndrome (CAPS) is characterized by continuous or frequently recurring abdominal pain and can result in functional loss across several life domains. The efficacy of the present management methods has not been established yet. We performed a prospective randomized controlled trial to explore the short-term efficacy of local analgesic (lidocaine) and opioid analgesic (sufentanil) in patients with CAPS. Methods: We consecutively enrolled 130 patients who met the Rome IV CAPS criteria and divided them into the sufentanil + lidocaine (S + L) group and sufentanil (S) group. Patients completed the pain rating scales, including the numeric rating scale (NRS) and verbal rating scale (VRS), 60 min before colonoscopy. All the patients were initially administered sufentanil. In the S + L group, we sprayed a 5 ml solution of lidocaine on the surface of ascending, transverse, descending, and sigmoid colon during colonoscope withdrawal, while 5 ml saline was sprayed in the S group. Follow up was performed 1 day, 3 days, 1 week, 2 weeks, 1 month, and 3 months after colonoscopy, to complete the pain scaling. Results: A comparison of the NRS and VRS showed that there were no significant differences between the S + L and S groups and within each group ( p > 0.05). Conclusions: Local analgesic lidocaine and opioid analgesic sufentanil showed negative efficacy during short-term observation. The opioid receptor blocker sufentanil did not worsen symptoms in patients with CAPS after colonoscopy under general anesthesia in the short term. [chictr.org.cn, Chinese Clinical Trial Identifier, ChiCTR-IOR-16008187]



2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 130-131
Author(s):  
Tiffany Cortes ◽  
Nicolas Musi ◽  
Chen-pin Wang ◽  
Joel Michalek ◽  
Sara Espinoza

Abstract We are conducting a double-blind, randomized controlled trial of metformin for frailty prevention. Participants are adults aged 65+ years with pre-diabetes assessed by 2-hour oral glucose tolerance test (OGTT). Those who are frail (Fried criteria) are excluded. Participants are randomized to metformin (maximum dose of 2,000 mg/day) vs. placebo and followed for 2 years. The primary outcome is frailty (category and score); secondary outcomes are physical performance and function (short physical performance battery, 6-minute walk, lower extremity strength), systemic and skeletal muscle tissue inflammation, muscle insulin signaling, insulin sensitivity (insulin clamp), glucose tolerance (OGTT), and body composition (dual-energy x-ray absorptiometry). Safety assessments occur every 3 months; frailty, systemic inflammation, and OGTT are assessed at baseline and every 6 months, and insulin clamp with muscle biopsies are assessed at baseline and every 12 months. To date, 85 subjects have been randomized; 120 completers are planned. Mean age is 72.8 ± 5.7 years, 55.3% are male, and 43.5% were Hispanic. Mean BMI is 30.2±5.8 kg/m2, waist circumference is 104.4 ±15.5 cm, fasting glucose is 102.3 ± 10.0 mg/dL, Hemoglobin A1c is 5.8 ±0.3, and glucose at 2 hours during OGTT is 167.3 ± 17.8 mg/dL. Metformin is being examined in this study as a potential therapeutic agent to prevent frailty in older adults with pre-diabetes. Findings from this trial may have future implications for the screening and potential treatment of pre-diabetes in older patients with metformin for the prevention of frailty.



2020 ◽  
Author(s):  
Agata Stróżyk ◽  
Andrea Horvath ◽  
Jane Muir ◽  
Hania Szajewska

Abstract Background Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders (FAPDs). However, in children, the evidence is very limited. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs. Methods We will perform a randomized, quadruple-blinded, controlled trial. Seventy-four children aged 8 to 18 years with a FAPD (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks. The primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS). Other outcomes will include changes in stool consistency, abdominal pain frequency, total scores on the Gastrointestinal Symptom Rating Scale, KIDSCREEN-10 Index and World Health Organization Five Well-Being Index, child’s school attendance and parents’ work absenteeism, and BMI-for-age z-score. Compliance, tolerability of the low-FODMAP diet, and adverse events also will be evaluated. Each FAPD subtype will be assessed separately.DiscussionThere is a need for high-quality evidence regarding the dietary management of children with FAPDs. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness, if any, of a low-FODMAP diet for the management of FAPDs in the pediatric population. The findings of this RCT will assist with the development of guidelines and influence the direction of further research. Trial registration: NCT04528914



PLoS ONE ◽  
2011 ◽  
Vol 6 (9) ◽  
pp. e25003 ◽  
Author(s):  
Peter Steinmann ◽  
Jürg Utzinger ◽  
Zun-Wei Du ◽  
Jin-Yong Jiang ◽  
Jia-Xu Chen ◽  
...  


2019 ◽  
Vol 74 (4) ◽  
pp. 530-537 ◽  
Author(s):  
Sergey Motov ◽  
Aidin Masoudi ◽  
Jefferson Drapkin ◽  
Cecily Sotomayor ◽  
Samuel Kim ◽  
...  




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