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The Lancet. Gastroenterology &... Feb 2024Many individuals without coeliac disease or wheat allergy reduce their gluten intake because they believe that gluten causes their gastrointestinal symptoms. Symptoms... (Randomized Controlled Trial)
Randomized Controlled Trial
The effect of expectancy versus actual gluten intake on gastrointestinal and extra-intestinal symptoms in non-coeliac gluten sensitivity: a randomised, double-blind, placebo-controlled, international, multicentre study.
BACKGROUND
Many individuals without coeliac disease or wheat allergy reduce their gluten intake because they believe that gluten causes their gastrointestinal symptoms. Symptoms could be affected by negative expectancy. Therefore, we aimed to investigate the effects of expectancy versus actual gluten intake on symptoms in people with non-coeliac gluten sensitivity (NCGS).
METHODS
This randomised, double-blind, placebo-controlled, international, multicentre study was done at the University of Leeds (Leeds, UK), Maastricht University (Maastricht, the Netherlands), and Wageningen University and Research (Wageningen, the Netherlands). People aged 18-70 years with self-reported NCGS (ie, gastrointestinal symptoms within 8 h of gluten consumption) without coeliac disease and wheat allergy were recruited. Participants had to follow a gluten-free or gluten-restricted diet for at least 1 week before (and throughout) study participation and had to be asymptomatic or mildly symptomatic (overall gastrointestinal symptom score ≤30 mm on the Visual Analogue Scale [VAS]) while on the diet. Participants were randomly assigned (1:1:1:1; blocks of eight; stratified by site and gender) to one of four groups based on the expectation to consume gluten-containing (E) or gluten-free (E) oat bread for breakfast and lunch (two slices each) and actual intake of gluten-containing (G) or gluten-free (G) oat bread. Participants, investigators, and those assessing outcomes were masked to the actual gluten assignment, and participants were also masked to the expectancy part of the study. The primary outcome was overall gastrointestinal symptom score on the VAS, which was measured at and corrected for baseline (before breakfast) and hourly for 8 h, with lunch served after 4 h, and analysed per-protocol. Safety analysis included all participants incorporated in the per-protocol analysis. The study is registered at ClinicalTrials.gov, NCT05779358, and has ended.
FINDINGS
Between Oct 19, 2018, and Feb 14, 2022, 165 people were screened and 84 were randomly assigned to EG (n=21), EG (n=21), EG (n=20), or EG (n=22). One person in the EG group was excluded due to not following test day instructions, leaving 83 participants in the per-protocol analysis. Median age was 27·0 years (IQR 21·0-45·0), 71 (86%) of 83 people were women, and 12 (14%) were men. Mean overall gastrointestinal symptom score was significantly higher for EG (16·6 mm [95% CI 13·1 to 20·0]) than for EG (6·9 mm [3·5 to 10·4]; difference 9·6 mm [95% CI 3·0 to 16·2], p=0·0010) and EG (7·4 mm [4·2 to 10·7]; difference 9·1 mm [2·7 to 15·6], p=0·0016), but not for EG (11·7 mm [8·3 to 15·1]; difference 4·9 mm [-1·7 to 11·5], p=0·28). There was no difference between EG and EG (difference 4·7 mm [-1·8 to 11·3], p=0·33), EG and EG (difference 4·2 mm [-2·2 to 10·7], p=0·47), and EG and EG (difference -0·5 mm [-7·0 to 5·9], p=1·0). Adverse events were reported by two participants in the EG group (itching jaw [n=1]; feeling lightheaded and stomach rumbling [n=1]) and one participant in the EG group (vomiting).
INTERPRETATION
The combination of expectancy and actual gluten intake had the largest effect on gastrointestinal symptoms, reflecting a nocebo effect, although an additional effect of gluten cannot be ruled out. Our results necessitate further research into the possible involvement of the gut-brain interaction in NCGS.
FUNDING
Government of the Netherlands Topsector Agri & Food Top Consortium for Knowledge and Innovation, AB Mauri Global Bakery Ingredients, Baking Industry Research Trust, Borgesius-Albert Heijn, CSM Innovation Centre, the International Maize and Wheat Improvement Center (CIMMYT), DSM Food Specialties, Fazer, Healthgrain Forum, the International Association for Cereal Science and Technology, the International Wheat Gluten Association, Lantmännen, Mondelez International, Nederlands Bakkerij Centrum, Nutrition & Santé, Puratos, Rademaker, Sonneveld Group, and Zeelandia HJ Doeleman.
Topics: Male; Humans; Female; Adult; Celiac Disease; Wheat Hypersensitivity; Glutens; Diet, Gluten-Free; Double-Blind Method
PubMed: 38040019
DOI: 10.1016/S2468-1253(23)00317-5 -
Advances in Clinical and Experimental... Sep 2023Proton pump inhibitors (PPIs) are currently the reference drugs for gastroesophageal reflux disease (GERD), but symptoms often recur after their withdrawal. Moreover,...
BACKGROUND
Proton pump inhibitors (PPIs) are currently the reference drugs for gastroesophageal reflux disease (GERD), but symptoms often recur after their withdrawal. Moreover, whether prokinetics or barrier drugs used alongside PPIs are more effective remains under debate.
OBJECTIVES
The aim of the study was to assess the efficacy of different therapeutic approaches to GERD treatment.
MATERIAL AND METHODS
We enrolled 211 grade A reflux esophagitis patients who consented to participate in this non-randomized, open-label trial. The study consisted of 6 sequentially administered medical treatments for GERD, lasting 2 months, with a 3-week washout period between each drug schedule: Group A: PPI (esomeprazole 40 mg/day before breakfast); Group B: mucosal protective drugs (a combination of hyaluronic acid, chondroitin sulfate and poloxamer 407, or a combination of hyaluronic acid, chondroitin sulfate and aluminum, 3 times daily after a meal); Group C: prokinetics (levosulpiride 25 mg or domperidone 10 mg, 3 times daily before a meal); Group D: barrier drug (alginate 3 times daily after a meal); Group E: PPI (esomeprazole 40 mg/day before breakfast) and mucosal protective drugs (a combination of hyaluronic acid, chondroitin sulfate and poloxamer 407, or a combination of hyaluronic acid, chondroitin sulfate and aluminum, before sleep); Group F: PPI (esomeprazole 40 mg/day before breakfast) and prokinetics (levosulpiride 25 mg or domperidone 10 mg before lunch and dinner). Symptoms were evaluated using the visual analogue scale (VAS) and global symptomatic score (GSS), as follows: heartburn: 0-3; retrosternal chest pain: 0-3; regurgitation: 0-3.
RESULTS
All but 2 treatments (groups C and D) significantly improved VAS and GSS, with group E showing the most significant GSS improvement. Group C had the highest number of dropouts due to treatment failure and reported more side effects.
CONCLUSION
Using PPIs and mucosal protective drugs resulted in significant symptom alleviation. However, the administration of prokinetics caused higher dropouts due to treatment failure.
PubMed: 37665080
DOI: 10.17219/acem/171001 -
Diabetes Care Sep 2023Meals are a consistent challenge to glycemic control in type 1 diabetes (T1D). Our objective was to assess the glycemic impact of meal anticipation within a fully... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Meals are a consistent challenge to glycemic control in type 1 diabetes (T1D). Our objective was to assess the glycemic impact of meal anticipation within a fully automated insulin delivery (AID) system among adults with T1D.
RESEARCH DESIGN AND METHODS
We report the results of a randomized crossover clinical trial comparing three modalities of AID systems: hybrid closed loop (HCL), full closed loop (FCL), and full closed loop with meal anticipation (FCL+). Modalities were tested during three supervised 24-h admissions, where breakfast, lunch, and dinner were consumed per participant's home schedule, at a fixed time, and with a 1.5-h delay, respectively. Primary outcome was the percent time in range 70-180 mg/dL (TIR) during the breakfast postprandial period for FCL+ versus FCL.
RESULTS
Thirty-five adults with T1D (age 44.5 ± 15.4 years; HbA1c 6.7 ± 0.9%; n = 23 women and n = 12 men) were randomly assigned. TIR for the 5-h period after breakfast was 75 ± 23%, 58 ± 21%, and 63 ± 19% for HCL, FCL, and FCL+, respectively, with no significant difference between FCL+ and FCL. For the 2 h before dinner, time below range (TBR) was similar for FCL and FCL+. For the 5-h period after dinner, TIR was similar for FCL+ and FCL (71 ± 34% vs. 72 ± 29%; P = 1.0), whereas TBR was reduced in FCL+ (median 0% [0-0%] vs. 0% [0-0.8%]; P = 0.03). Overall, 24-h control for HCL, FCL, and FCL+ was 86 ± 10%, 77 ± 11%, and 77 ± 12%, respectively.
CONCLUSIONS
Although postprandial control remained optimal with hybrid AID, both fully AID solutions offered overall TIR >70% with similar or lower exposure to hypoglycemia. Anticipation did not significantly improve postprandial control in AID systems but also did not increase hypoglycemic risk when meals were delayed.
Topics: Male; Humans; Adult; Female; Middle Aged; Insulin; Diabetes Mellitus, Type 1; Blood Glucose; Hypoglycemic Agents; Meals; Insulin, Regular, Human; Insulin Infusion Systems; Cross-Over Studies
PubMed: 37478323
DOI: 10.2337/dc23-0119 -
Journal of Atherosclerosis and... Sep 2023Little is known regarding the association between breakfast type and cardiovascular mortality. We examined the associations between breakfast type and risks of mortality...
AIM
Little is known regarding the association between breakfast type and cardiovascular mortality. We examined the associations between breakfast type and risks of mortality from stroke, coronary heart disease (CHD), and total cardiovascular disease (CVD).
METHODS
A total of 85,319 males and females aged 40 to 79 years who were free from CVD and cancers at baseline were involved in this study. The participants were divided into five groups according to their self-reported breakfast types: Japanese breakfast, Western breakfast, mixed Japanese-Western breakfast, other breakfast, and skipping breakfast groups. All hazard ratios (HRs) were estimated using Cox proportional hazards regression models after adjusting for the potential confounding factors.
RESULTS
During the median 19-year follow-up, we identified CVD deaths of 5,870 subjects. Compared to the Japanese breakfast, the multivariable HRs (95% CIs) of total CVD were 0.64 (0.52-0.79) for mixed Japanese-Western breakfast, 0.90 (0.77-1.04) for Western breakfast, 1.24 (0.95-1.61) for other breakfast, and 1.31 (1.00-1.71) for skipping breakfast. The corresponding HRs (95% CIs) of total stroke were 0.67 (0.49-0.91), 0.83 (0.66-1.05), 1.15 (0.76-1.74), and 1.25 (0.82-1.92), and those of CHD were 0.73 (0.48-1.12), 1.08 (0.81-1.44), 1.09 (0.60-1.98), and 1.77 (1.11-2.83).
CONCLUSION
Compared to Japanese breakfast, mixed Japanese-Western breakfast may have a protective role in cardiovascular mortality whereas skipping breakfast may harm cardiovascular health.
Topics: Male; Female; Humans; Cohort Studies; Japan; Breakfast; Prospective Studies; Stroke; Cardiovascular Diseases; Coronary Disease; Proportional Hazards Models; Risk Factors
PubMed: 36543187
DOI: 10.5551/jat.63564 -
Nutrients Oct 2023Previously, it has been indicated that oat polar lipids included in a liquid meal may have the potential to beneficially modulate various cardiometabolic variables. The... (Randomized Controlled Trial)
Randomized Controlled Trial
Inclusion of Oat Polar Lipids in a Solid Breakfast Improves Glucose Tolerance, Triglyceridemia, and Gut Hormone Responses Postprandially and after a Standardized Second Meal: A Randomized Crossover Study in Healthy Subjects.
Previously, it has been indicated that oat polar lipids included in a liquid meal may have the potential to beneficially modulate various cardiometabolic variables. The purpose of this study was to evaluate the effects of oat polar lipids in a solid food matrix on acute and second meal glucose tolerance, blood lipids, and concentrations of gut-derived hormones. The oat polar lipids were consumed at breakfast and effects on the biomarkers were investigated in the postprandial period and following a standardized lunch. Twenty young, healthy subjects consumed in total four different breakfast meals in a crossover study design. The breakfasts consisted of 1. White wheat bread (WWB) with an added 7.5 g of oat polar lipids (PLL); 2. WWB with an added 15 g of oat polar lipids (PLH); 3. WWB with and added 16.6 g of rapeseed oil (RSO) as a representative of commonly consumed oils; and 4. WWB consumed alone, included as a reference. All products with added lipids contained equivalent amounts of fat (16.6 g) and available carbohydrates (50 g). Rapeseed oil was added to the oat polar lipid meals to equal 16.6 g of total fat. The standardized lunch was composed of WWB and meatballs and was served 3.5 h after the breakfast. Test variables (blood glucose, serum insulin, triglyceride (TG), free fatty acids (FFA), ghrelin, GLP-1, PYY, and GIP) were measured at fasting and repeatedly during the 5.5 h after ingestion of the breakfast. After breakfast, PLH substantially lowered postprandial glucose and insulin responses (iAUC 0-120 min) compared with RSO and WWB ( < 0.05). Furthermore, a reduced glycaemic response to lunch (210-330 min) was observed following the PLH breakfast compared to all of the other breakfasts served ( < 0.05). Oat polar lipids (PLH) significantly reduced TG and ghrelin and increased circulating gut hormones GLP-1 and PYY compared to RSO ( < 0.05). The results show that exchanging part of the dietary lipids with oat polar lipids has the potential to improve postprandial blood glucose regulation and gut hormones and thus may have a preventive effect against type 2 diabetes.
Topics: Humans; Ghrelin; Breakfast; Blood Glucose; Cross-Over Studies; Avena; Healthy Volunteers; Diabetes Mellitus, Type 2; Rapeseed Oil; Dietary Fiber; Gastrointestinal Hormones; Meals; Insulin; Glucagon-Like Peptide 1; Lipids; Postprandial Period
PubMed: 37892464
DOI: 10.3390/nu15204389 -
Nutrients Jun 2023The United States (US) School Breakfast Program provides Breakfast After The Bell (BATB) to alleviate hunger, provide nutrition, and ensure students have a healthy start... (Review)
Review
Alternative School Breakfast Service Models and Associations with Breakfast Participation, Diet Quality, Body Mass Index, Attendance, Behavior, and Academic Performance: A Systematic Review.
The United States (US) School Breakfast Program provides Breakfast After The Bell (BATB) to alleviate hunger, provide nutrition, and ensure students have a healthy start to the day. This study aims to review the evidence regarding the impact of BATB on students' diet and academic outcomes, including participation, diet quality and consumption, body mass index (BMI) and weight status, attendance, classroom behavior, and academic performance. The articles were extracted from three electronic databases and published since the start of the literature through December 2022. Studies were peer-reviewed; quantitative research articles or government reports; and conducted in public or private elementary, middle, and high schools. Quality was assessed using the Newcastle-Ottawa Scale. Thirty-seven studies were included in this review. This review found BATB increased school breakfast participation, improved diet quality, and improved classroom behavior particularly among students from racial and ethnic minority backgrounds and students eligible for free or reduced-price meals. The impact of BATB on BMI and weight status, academic achievement and attendance was mixed. This review is particularly timely given free school meals and updated school nutrition standards are being prioritized over the next decade in the US. Thus, it is important to evaluate the nutritional and educational outcomes of BATB. (PROSPERO registration: CRD42021289719).
Topics: Humans; United States; Body Mass Index; Breakfast; Ethnicity; Minority Groups; Diet; Food Services
PubMed: 37447277
DOI: 10.3390/nu15132951 -
Antioxidants (Basel, Switzerland) Jul 2023Vitamins, hormones, free radicals, and antioxidant substances significantly influence athletic performance. The aim of this study was to evaluate whether these...
Vitamins, hormones, free radicals, and antioxidant substances significantly influence athletic performance. The aim of this study was to evaluate whether these biological mediators changed during the season and if this was associated with the rate of improvement in performance after training, assessed by means of a standardized test. Professional male soccer players took part in the study. Two evaluations were performed: the first in the pre-season period and the second at the mid-point of the official season, after about 6 months of intensive training and weekly matches. Blood levels of vitamins D, B12, and folic acid, testosterone and cortisol, free radicals, and antioxidant substances were measured. Two hours after breakfast, a Yo-Yo test was performed. The relationships between the biological mediators and the rate of improvement after training (i.e., the increase in meters run in the Yo-Yo test between the pre-season and mid-season periods) were evaluated by means of a linear mixed models analysis. Results: Eighty-two paired tests were performed. The athletes showed better performance after training, with an increase in the meters run of about 20%. No significant relationships between the vitamin and hormone values and the gain in the performance test were observed. Plasmatic levels of free radicals increased significantly, as did the blood antioxidant potential. An indirect relationship between oxidative stress and the improvement in performance was observed (free radicals β ± SE: = -0.33 ± 0.10; -value = 0.001), with lower levels of oxidative stress being associated with higher levels of performance in the Yo-Yo test. Monitoring the measures of oxidative stress could be a useful additional tool for coaches in training and/or recovery programs tailored to each player.
PubMed: 37508008
DOI: 10.3390/antiox12071470 -
Asia Pacific Journal of Clinical... Mar 2024The effect of different coffee and tea consumption on postprandial glucose and lipid metabolism has never been reported previously. The aim of the present study was to... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND OBJECTIVES
The effect of different coffee and tea consumption on postprandial glucose and lipid metabolism has never been reported previously. The aim of the present study was to investigate the effect of different coffee or tea consumption at breakfast on postprandial cardiometabolic risk factors in healthy individuals.
METHODS AND STUDY DESIGN
Eighteen healthy young subjects completed the trial. After 8-hour overnight fast, volunteers either ingested water, freeze-dried coffee, spray-dried coffee, green tea, black tea or oolong tea together with a breakfast consisting of an egg and 180g deep-fried dough sticks. Blood was drawn at 0h, 0.5h, 1h, 2h, and 3h.
RESULTS
The differences in triglyceride (TG) values relative to the baseline levels at 2h and 3h of green tea was significantly decreased compared with black tea and oolong tea (p<0.05). Compared with black tea, green tea and oolong tea significantly reduced postprandial total cholesterol (TC) levels (p<0.05, p<0.01), respectively. Furthermore, the serum concentrations of high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) were substantially decreased after oolong tea consumption compared with black tea (p<0.05, p<0.01).
CONCLUSIONS
Green tea ingestion can lower the elevation of serum TG and TC levels after high-fat or high-cholesterol diets. Our findings have far-reaching implications given the widespread use of coffee and tea and the current concern over cardiometabolic risk factors.
Topics: Humans; Coffee; Cross-Over Studies; Cardiometabolic Risk Factors; Tea; Cholesterol, LDL
PubMed: 38494692
DOI: 10.6133/apjcn.202403_33(1).0011 -
Trials Dec 2023Vonoprazan results in more potent acid suppression for gastroesophageal reflux disease (GERD) than proton pump inhibitors. It has only been approved for treating erosive...
Different dosages of vonoprazan for gastroesophageal reflux disease: study protocol for a pragmatic, crossover-cluster, randomized controlled trial with patient preference arms.
BACKGROUND
Vonoprazan results in more potent acid suppression for gastroesophageal reflux disease (GERD) than proton pump inhibitors. It has only been approved for treating erosive esophagitis in China, but 30-40% of GERD patients cannot achieve the goal of treatment with vonoprazan 20 mg daily. This study aims to investigate whether vonoprazan could relieve the symptoms of Chinese patients with non-erosive reflux disease (NERD) and whether increased dosage or different times of dosing could increase the response rate of GERD.
METHODS
This study is a pragmatic, open-label, crossover-cluster, randomized controlled trial with patient preference arms. Two thousand eight hundred eighty patients with GERD from 48 hospitals in China will be enrolled. These hospitals will be divided into a compulsory randomization cluster (24 hospitals) and a patient preference cluster (24 hospitals). Patients in the compulsory randomization cluster will be randomized to three regimens according to the crossover-cluster randomization. Patients in the patient preference cluster may choose to receive any regimen if they have a preference; otherwise, patients will be randomly assigned. The three treatment regimens will last 4 weeks, including (1) vonoprazan 20 mg p.o. after breakfast, (2) vonoprazan 20 mg p.o. after dinner, and (3) vonoprazan 20 mg p.o. after breakfast and after dinner. Patients will attend a baseline visit, a 4-week e-diary, a fourth-week visit, and a sixth-month visit online. The primary outcome is the symptom relief rate of all patients after 4-week therapy. Secondary outcomes include the healing rate of EE patients, the severity of symptoms, compliance with the therapy at the fourth-week follow-up visit, recurrent symptoms, and the frequency of self-conscious doctor visits at the sixth-month follow-up visit.
DISCUSSION
This trial will explore the effectiveness of different regimens of vonoprazan that will be implemented with GERD patients in China. The randomization with patient preferences considered and the crossover-cluster component may improve the robustness and extrapolation of study conclusions.
TRIAL REGISTRATION
https://www.chictr.org.cn ChiCTR2300069857. Registered on 28 March 2023.
PROTOCOL VERSION
February 18, 2023, Version 2.
Topics: Humans; Patient Preference; Gastroesophageal Reflux; Proton Pump Inhibitors; Pyrroles; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38041136
DOI: 10.1186/s13063-023-07760-9 -
Clinics in Orthopedic Surgery Aug 2023This prospective randomized controlled study aimed to determine the effects of abdominal massage on constipation management in elderly patients with hip fractures. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
This prospective randomized controlled study aimed to determine the effects of abdominal massage on constipation management in elderly patients with hip fractures.
METHODS
From August 2017 to December 2018, patients aged above 65 years with hip fractures (n = 88) were randomly assigned to a massage group that received a bowel massage (n = 48) or a control group that did not receive a bowel massage (n = 40). Patients in the bowel massage group received a bowel massage from a trained caregiver after breakfast at approximately 9:00 AM for an hour. On admission, 5 days after surgery, and on the day of discharge, the patient's normal and actual defecation pattern, stool consistency, and any problems with defecation were assessed through a structured interview. The questionnaire comprising the Bristol Stool Scale, patient assessment of constipation, time to defecation, medication for defecations, failure to defecate, cause of admission, admission period, and date of surgery were recorded. Statistical analyses were performed 5 days after surgery and on the day of discharge.
RESULTS
The mean age of the study cohort was 81.4 years (range, 65-99 years). The number of constipation remedies was significantly lower in the massage group than in the control group on postoperative day (POD) 5 and at discharge (9 vs. 15, = 0.049 and 6 vs. 11, = 0.039, respectively). The number of defecation failures was significantly lower in the massage group than in the control group (10 vs. 17, = 0.028) on POD 5. However, the number of defecation failures at discharge was not significantly different between the two groups ( = 0.131). The development of postoperative ileus ( = 0.271) and length of hospital stay ( = 0.576) were not different between the groups.
CONCLUSIONS
The number of constipation remedies was significantly lower in the massage group than in the control group on POD 5 and discharge, and the number of defecation failures was significantly lower in the massage group than in the control group on POD 5. Therefore, abdominal massage may be considered as an independent nursing initiative for constipation management.
Topics: Aged; Humans; Aged, 80 and over; Defecation; Prospective Studies; Constipation; Massage; Hip Fractures
PubMed: 37529190
DOI: 10.4055/cios22091