Is a Non-Caloric Sweeteners-Free Diet Good To Treat Functional Gastrointestinal Disorder Symptoms? A Randomized Controlled Trial

Abstract BackgroundA diet containing Non-Caloric Sweeteners (NCS) is used to reduce calorie intake and blood sugar peaks in overweight and obese subjects. Nevertheless, some animal studies suggest that NCS consumption may increase Functional Gastrointestinal Disorder symptoms (FGDs); however, there are scant clinical trials in humans. The aim of the study was to compare the effect of consuming a diet containing NCS (c-NCS) versus a Non-Caloric Sweetener-free diet (NCS-f) on FGDs in adult volunteers.MethodsThis was a randomized, controlled, parallel-group study using two different diets for five weeks: diet c-NCS contained 50-100 mg/day NCS (80% sucralose and 20% aspartame, acesulfame K, and saccharin); NCS-f diet contained less than 10 mg/day NCS. FGDs were recorded according to the Rome III criteria, gastrointestinal symptom questionnaire, Bristol scale, food frequency questionnaire, and consumption questionnaire at the beginning (PreTx) and at the end (PostTx) of the study by a gastroenterologist and a nutritionist. This study conducted according to the CONSORT guidelines and it was registered at clinicaltrials.gov (identifier code: NCT04129762).ResultsParticipants were more often women than men in both groups (59% and 62%), with a median age of 22 years. FGDs were similar in both groups at the beginning of the study (PreTx) but significantly increased in the diet c-NCS group after five weeks (PostTx). The percentage of participants with diarrhea (PreTx=19% versus PstTx=56%; p=0.02), post-prandial discomfort (PreTx=9% versus PstTx=39%; p=0.02), constipation (PreTx=30% versus PostTx=56%; p<0.01), and burning or retrosternal pain (PreTx=13% versus PostTx=33%; p<0.01) significantly increased in the diet c-NCS group. Conversely, abdominal pain (PreTx=15% versus PostTx=3%; p=0.04), post-prandial discomfort (PreTx=26% versus PostTx=6%; p=0.02), burning or retrosternal pain (PreTx=15% versus PostTx=0%; p=0.02), early satiety (PreTx=18% versus PostTx=3%; p<0.01), and epigastric pain (PreTx=38% versus PostTx=3%; p<0.01) significantly decreased in the NCS-f diet group.Conclusion This study shows that diet c-NCS associates with increased FGDs including diarrhea, post-prandial discomfort, constipation, and burning or retrosternal pain. Interestingly, NCS-f diet concurs with decreased FGDs such as abdominal pain, post-prandial discomfort, burning or retrosternal pain, early satiety, and epigastric pain. A NCS-f diet could be a complementary strategy to alleviate FGDs. Trial registration: The ethics committee of the hospital approved this study with the registration number DI/19/301/03/020. This trial was registered at clinicaltrials.gov (identifier code: NCT04129762).

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Correction: Evaluating Safety and Efficacy of Follow-up for Patients With Abdominal Pain Using Video Consultation (SAVED Study): Randomized Controlled Trial (Preprint)

10.2196/preprints.22018 ◽

2020 ◽

Author(s):

Dinesh Gunasekeran

Keyword(s):

Randomized Controlled Trial ◽

Abdominal Pain ◽

Controlled Trial ◽

Safety And Efficacy ◽

Randomized Controlled ◽

Video Consultation

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Evaluation of the short-term efficacy of local analgesic (lidocaine) and opioid analgesic (sufentanil) on patients with centrally mediated abdominal pain syndrome: a randomized controlled trial

Therapeutic Advances in Gastroenterology ◽

10.1177/17562848211021783 ◽

2021 ◽

Vol 14 ◽

pp. 175628482110217

Author(s):

Hang Yang ◽

Honglin Chen ◽

Bing Hu

Keyword(s):

Randomized Controlled Trial ◽

Abdominal Pain ◽

Rating Scales ◽

Rating Scale ◽

Controlled Trial ◽

Opioid Analgesic ◽

Pain Syndrome ◽

Short Term ◽

Randomized Controlled ◽

Term Efficacy

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]

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Effect of electroacupuncture at homotopic and heterotopic acupoints on abdominal pain in patients with irritable bowel syndrome: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-018-2948-1 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Yanhui Peng ◽

Hui You ◽

Xiaoman Chen ◽

Yanbing Chen ◽

Yiling Yang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Study Protocol ◽

Controlled Trial ◽

Randomized Controlled ◽

Irritable Bowel

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A Randomized Controlled Study of Efficacy and Safety Profile of Levosulpiride and Itopride in Functional Dyspepsia

Journal of Mahatma Gandhi University of Medical Sciences and Technology ◽

10.5005/jp-journals-10057-0131 ◽

2020 ◽

Vol 5 (2) ◽

pp. 50-56

Author(s):

Ganesh Narain Saxena ◽

Saumya Mathur

Keyword(s):

Functional Dyspepsia ◽

Safety Profile ◽

Epigastric Pain ◽

Randomized Controlled Study ◽

Controlled Study ◽

Efficacy And Safety ◽

Early Satiety ◽

Postprandial Fullness ◽

Presenting Symptoms ◽

Randomized Controlled

ABSTRACT Introduction Dyspepsia is a clinical problem of considerable magnitude for the healthcare system due to the high prevalence and chronic and recurrent nature of symptoms. Earlier dyspepsia was referred to as a heterogeneous group of symptoms in the upper abdomen and retrosternal which are related to ingestion of meals and include heartburn, regurgitation, epigastric pain, epigastric burning, postprandial fullness/distension, early satiety, bloating, belching, anorexia, nausea, and vomiting. This has prompted the search for newer agents with equal efficacy but lower side effect potential such as levosulpiride and itopride. Aim and objectives To evaluate and compare the efficacy of the newer drugs like levosulpiride and itopride in functional dyspepsia. Observations and results The most common presenting symptoms in the present study were epigastric fullness (81%), upper abdominal pain (55%), early satiety (52%), and epigastric burning (45%). Less common symptoms were bloating (27%), belching (11%), heartburn (10%), and nausea (8%). Conclusion Drugs, itopride and levosulpiride, were equally effective in ameliorating different symptoms of functional dyspepsia at the end of 4 weeks of treatment. There was a significant reduction in mean global symptom score (GSS) and mean duration score and mean score of severity in follow-up visits at the 2nd and 4th week from the day of presentation (p value < 0.05). How to cite this article Saxena GN, Mathur S. A Randomized Controlled Study of Efficacy and Safety Profile of Levosulpiride and Itopride in Functional Dyspepsia. J Mahatma Gandhi Univ Med Sci Tech 2020;5(2):50–56.

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Effect of a Low-fodmap Diet for the Management of Functional Abdominal Pain Disorders in Children: A Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-73062/v1 ◽

2020 ◽

Author(s):

Agata Stróżyk ◽

Andrea Horvath ◽

Jane Muir ◽

Hania Szajewska

Keyword(s):

Randomized Controlled Trial ◽

Abdominal Pain ◽

Controlled Trial ◽

Well Being ◽

World Health ◽

Reliable Change Index ◽

Functional Abdominal Pain ◽

Regular Diet ◽

Randomized Controlled ◽

Fodmap Diet

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

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Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake

Cell Metabolism ◽

10.1016/j.cmet.2019.05.008 ◽

2019 ◽

Vol 30 (1) ◽

pp. 67-77.e3 ◽

Cited By ~ 202

Author(s):

Kevin D. Hall ◽

Alexis Ayuketah ◽

Robert Brychta ◽

Hongyi Cai ◽

Thomas Cassimatis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Food Intake ◽

Controlled Trial ◽

Calorie Intake ◽

Randomized Controlled ◽

Ad Libitum

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Effect of a 2-year diet intervention with walnuts on cognitive decline. The Walnuts And Healthy Aging (WAHA) study: a randomized controlled trial

American Journal of Clinical Nutrition ◽

10.1093/ajcn/nqz328 ◽

2020 ◽

Vol 111 (3) ◽

pp. 590-600 ◽

Cited By ~ 8

Author(s):

Aleix Sala-Vila ◽

Cinta Valls-Pedret ◽

Sujatha Rajaram ◽

Nina Coll-Padrós ◽

Montserrat Cofán ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Decline ◽

Healthy Aging ◽

Controlled Trial ◽

Control Diet ◽

Brain Mri ◽

Diet Group ◽

Randomized Controlled ◽

Post Hoc ◽

Brain Fmri

ABSTRACT Background Walnut consumption counteracts oxidative stress and inflammation, 2 drivers of cognitive decline. Clinical data concerning effects on cognition are lacking. Objectives The Walnuts And Healthy Aging study is a 2-center (Barcelona, Spain; Loma Linda, CA) randomized controlled trial examining the cognitive effects of a 2-y walnut intervention in cognitively healthy elders. Methods We randomly allocated 708 free-living elders (63–79 y, 68% women) to a diet enriched with walnuts at ∼15% energy (30–60 g/d) or a control diet (abstention from walnuts). We administered a comprehensive neurocognitive test battery at baseline and 2 y. Change in the global cognition composite was the primary outcome. We performed repeated structural and functional brain MRI in 108 Barcelona participants. Results A total of 636 participants completed the intervention. Besides differences in nutrient intake, participants from Barcelona smoked more, were less educated, and had lower baseline neuropsychological test scores than those from Loma Linda. Walnuts were well tolerated and compliance was good. Modified intention-to-treat analyses (n = 657) uncovered no between-group differences in the global cognitive composite, with mean changes of −0.072 (95% CI: −0.100, −0.043) in the walnut diet group and −0.086 (95% CI: −0.115, −0.057) in the control diet group (P = 0.491). Post hoc analyses revealed significant differences in the Barcelona cohort, with unadjusted changes of −0.037 (95% CI: −0.077, 0.002) in the walnut group and −0.097 (95% CI: −0.137, −0.057) in controls (P = 0.040). Results of brain fMRI in a subset of Barcelona participants indicated greater functional network recruitment in a working memory task in controls. Conclusions Walnut supplementation for 2 y had no effect on cognition in healthy elders. However, brain fMRI and post hoc analyses by site suggest that walnuts might delay cognitive decline in subgroups at higher risk. These encouraging but inconclusive results warrant further investigation, particularly targeting disadvantaged populations, in whom greatest benefit could be expected. This trial was registered at clinicaltrials.gov as NCT01634841.

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