[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658830":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":63,"studyPopulation":49,"armGroups":64,"interventions":76,"overallOfficials":85,"centralContacts":89,"locations":98,"responsibleParty":122,"collaborators":124,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":49,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":101,"whyStopped":49,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"University of Bergen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Incremental Area Under the Curve (iAUC) for postprandial glucose response to breakfast","Incremental area under the curve (iAUC, 0-180 minutes post-meal) for glucose following the standardized breakfast meal, calculated using the trapezoidal rule on continuous glucose monitoring (CGM) readings, counting only area above the pre-meal reference (mean CGM glucose in the 15 minutes before meal start). Evaluated as the average across evaluable breakfast meal-days (up to 3) within each 3-day intervention period.","Days 4-6 (Intervention period 1) and days 11-13 (Intervention period 2)",[14,18,21,24,27,30,33,36,39,42,45],{"measure":15,"description":16,"timeFrame":17},"Incremental Area Under the Curve (iAUC) for postprandial glucose response to lunch","Incremental area under the curve (iAUC, 0-180 minutes post-meal) for glucose following the standardized lunch meal, calculated using the trapezoidal rule on continuous glucose monitoring (CGM) readings, counting only area above the pre-meal reference (mean CGM glucose in the 15 minutes before meal start). Evaluated as the average across evaluable lunch meal-days (up to 3) within each 3-day intervention period.","Days 4-6 (Intervention period 1) and Days 11-13 (Intervention period 2)",{"measure":19,"description":20,"timeFrame":17},"Incremental Area Under the Curve (iAUC) for combined breakfast and lunch meals","Combined average postprandial glucose iAUC (0-180 minutes post-meal) calculated across all breakfast and lunch meals within each 3-day intervention period.",{"measure":22,"description":23,"timeFrame":17},"Peak postprandial glucose concentration","Maximum glucose concentration recorded within 180 minutes following breakfast and lunch bread meals, averaged across all meal occasions within each 3-day intervention period.",{"measure":25,"description":26,"timeFrame":17},"2-Hour postprandial glucose concentration","Glucose concentration at 120 minutes following the start of breakfast and lunch bread meals, averaged across all meal occasions within each 3-day intervention period.",{"measure":28,"description":29,"timeFrame":17},"Continuous glucose monitoring Standard Deviation (SD)","Standard deviation of glucose readings during the daytime period, starting at the breakfast meal start and ending at dinner time or 480 minutes post-breakfast (whichever is earlier).",{"measure":31,"description":32,"timeFrame":17},"Continuous glucose monitoring Coefficient of Variation (%CV)","Coefficient of variation of CGM readings evaluated over the daytime period (from breakfast start to dinner or 480 minutes post-breakfast).",{"measure":34,"description":35,"timeFrame":17},"Mean Amplitude of Glycemic Excursions (MAGE)","Average of daytime glucose excursions exceeding 1 standard deviation of the mean glucose value, evaluated from breakfast start to dinner or 480 minutes post-breakfast (whichever is earlier). The MAGE algorithm and software version are fixed in advance and included in the deposited analysis code.",{"measure":37,"description":38,"timeFrame":17},"Day-to-day response variability for breakfast glucose iAUC","Within-participant standard deviation of daily breakfast postprandial glucose iAUC (0-180 minutes) evaluated across the 3 days within each intervention period.",{"measure":40,"description":41,"timeFrame":17},"Day-to-day response variability for lunch glucose iAUC","Within-participant standard deviation of daily lunch postprandial glucose iAUC (0-180 minutes) evaluated across the 3 days within each intervention period.",{"measure":43,"description":44,"timeFrame":17},"Within-day difference in iAUC between breakfast and lunch","Within-participant difference in postprandial glucose iAUC (0-180 minutes) between the breakfast and lunch meals when consuming the same bread type within the same day. Reported descriptively only; meal occasion is not randomized and is confounded with time of day and prior food intake, so this comparison is not interpreted as a causal effect of meal timing.",{"measure":46,"description":47,"timeFrame":48},"Gastrointestinal Symptoms (GSRS-IBS Bloating Subscale)","Difference between RM and SM in gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS), Bloating subscale (7-point Likert scale; covering bloating, passing gas, and visible distention), self-reported with a 3-day recall period aligned to each intervention period.","Day 6 (end of Intervention Period 1) and Day 13 (end of Intervention Period 2), each based on a 3-day symptom recall",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":49,"timePerspective":49,"maskingInfo":55},"RANDOMIZED","CROSSOVER","Crossover Assignment - the STONEMILL protocol randomizes each participant to one of two treatment sequences (roller-milled then stone-milled, or the reverse), so every participant receives both interventions in a different order, which is the definition of a crossover design (as opposed to Parallel, Factorial, or Single Group Assignment).","BASIC_SCIENCE",{"masking":56,"maskingDescription":57,"whoMasked":58},"QUADRUPLE","Both study breads are produced by Nofima to be as similar as possible and supplied to the trial site under neutral labels (\"Bread A\"\u002F\"Bread B\"); the identity of each label is withheld from the site until the study ends. Participants and site staff - including those enrolling participants, administering bread meals, and maintaining participant contact - are blinded to milling method and treatment allocation. CGM data download, artifact screening, meal-time alignment, and computation of the primary endpoint are performed with condition labels masked; the primary model is fitted and its diagnostics inspected before unmasking. At study end, participants report which bread they believe was stone-milled, used in a prespecified sensitivity analysis of gastrointestinal outcomes.",[59,60,61,62],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Wheat is processed today almost exclusively by roller milling, a method introduced in the late 19th century that has largely displaced traditional stone milling. This technological shift has altered the physical structure of flour to a much greater extent than existing research has examined: because intact plant structure limits enzymatic access to starch, coarser, less fractionated flour is expected to be digested more slowly and produce a smaller postprandial glucose rise than finely milled flour. Stone milling has been found to produce measurably coarser, less fully fractionated flour than roller milling, and one prior human trial - conducted in adults with type 2 diabetes, using a single-occasion glycemic index design - found a significantly lower postprandial glucose response to bread made from stone-ground versus roller-milled wholegrain wheat flour. Whether this effect is present and reproducible in healthy adults, using repeated within-condition measurement rather than a single test occasion, has not been established. Separately, cereal-based foods are a common source of gastrointestinal symptoms even without diagnosed gastrointestinal disease, and milling method could plausibly influence gastrointestinal tolerance through its effects on particle size and fermentable substrate delivery to the colon, independent of its effects on glycemic response.\n\nThis trial is a randomized, crossover study designed to isolate the effect of milling method - stone milling versus roller milling - while holding grain source, whole-grain fraction, fermentation method, and carbohydrate dose constant across conditions. Both study breads are produced from a single batch of wheat grain in one dedicated milling run per method, are matched on 100% whole-grain composition (all milling streams recombined after roller milling), and are sourdough-fermented using the same starter and protocol. Flour particle-size distribution and damaged starch - the two properties through which milling method is expected to act - are measured and reported but deliberately not standardized between conditions, since doing so would remove the mechanism under study. Each bread-containing meal delivers a fixed, directly analyzed dose of available carbohydrate rather than a fixed number of slices, unless the two breads are shown before enrollment to match within 5% per slice.\n\nEach participant is randomized (stratified by sex, in permuted blocks, by a person independent of trial conduct) to one of two treatment sequences and consumes each bread type for a 3-day period, separated by a 4-day washout of standardized yeast-baked bread that also aligns each period to the same weekdays across the two halves of the study and attenuates carryover from the preceding intervention. A continuous glucose monitor is worn continuously for the full 14-day study, beginning with a 1-day sensor calibration period; breakfast and lunch bread meals are eaten at fixed times of day at least 4 hours apart, and each participant fixes their own topping and beverage pattern at the outset and repeats it identically throughout, holding non-bread dietary components constant within, though not between, participants. Both study staff and participants are blinded to which bread corresponds to which milling method: breads are prepared and blinded by the research institute producing them (Nofima), and treatment allocation is withheld from the analysis dataset until after data lock. Throughout the study, participants record all food and beverage intake, including photographs of meals, and higher-intensity physical activity, via a dedicated digital application that timestamps bread-meal entries at the point of consumption.\n\nThe primary analysis uses a design-driven mixed-effects model with fixed effects for treatment and period, a variance structure allowing period-specific residual variance to reflect known changes in CGM sensor accuracy across the wear period, and baseline handled as recommended by Kenward and Roger to avoid cross-level bias - reflecting that single-occasion postprandial measurements have poor within-participant reliability, which is why the trial averages responses over three days per condition rather than relying on a single test day. No formal statistical test for carryover is performed, since testing for carryover and conditioning the primary analysis on that test is known to inflate the type I error rate in two-period crossover designs; carryover is instead addressed through prespecified sensitivity analyses, including a model restricted to the sole strictly pre-exposure baseline and a descriptive comparison of period-2 baseline values by sequence. Additional prespecified analyses examine the time course of the treatment effect across the three days of each period, differences between breakfast and lunch, and day-to-day response variability. The planned sample size was informed by a power calculation transferring effect-size and reliability estimates from the only prior comparator trial, adjusted for this trial's repeated-measures design.\n\nThe trial is conducted at Haukeland University Hospital (Bergen, Norway) as an investigator-initiated study, in collaboration with Nofima (production and blinding of study breads) and two Norwegian mills providing grain and milling in-kind. Findings are expected to apply specifically to the wheat batch, mills, fermentation protocol, carbohydrate dose, and population studied; given the trial's short, acute design in healthy young adults, results cannot support inference about long-term glycemic control, insulin sensitivity, body weight, or cardiometabolic disease risk.",[65,72],{"label":66,"type":67,"description":68,"interventionNames":69},"Sequence AB: Roller-Milled Sourdough Bread then Stone-Milled Sourdough Bread","EXPERIMENTAL","Participants complete a 14-day continuous glucose monitoring (CGM) period:\n\n1. Days 1-3 (Baseline 1): Consume standardized baseline yeast bread at breakfast and lunch.\n2. Days 4-6 (Intervention 1): Consume roller-milled wholegrain wheat sourdough bread at breakfast and lunch.\n3. Days 7-10 (Baseline 2): Consume standardized baseline yeast bread at breakfast and lunch for 4 days.\n4. Days 11-13 (Intervention 2): Consume stone-milled wholegrain wheat sourdough bread at breakfast and lunch.",[70,71],"Other: Stone-milled wheat flour bread","Other: Roller-milled wheat flour bread (sourdough)",{"label":73,"type":67,"description":74,"interventionNames":75},"Sequence BA: Stone-Milled Sourdough Bread then Roller-Milled Sourdough Bread","Participants complete a 14-day continuous glucose monitoring (CGM) period:\n\n1. Days 1-3 (Baseline 1): Consume standardized baseline yeast bread at breakfast and lunch.\n2. Days 4-6 (Intervention 1): Consume stone-milled wholegrain wheat sourdough bread at breakfast and lunch.\n3. Days 7-10 (Baseline 2): Consume standardized baseline yeast bread at breakfast and lunch for 4 days.\n4. Days 11-13 (Intervention 2): Consume roller-milled wholegrain wheat sourdough bread at breakfast and lunch.",[70,71],[77,81],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":49},"Stone-milled wheat flour bread","Sourdough-fermented bread made from 100% wholegrain wheat flour milled by traditional stone milling (same wheat batch, starter, and fermentation protocol as the roller-milled bread). Consumed at breakfast and lunch, providing a fixed dose of available carbohydrate (\\~50 g per meal, \\~3 slices), for 3 consecutive days.",[66,73],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":49},"Roller-milled wheat flour bread (sourdough)","Sourdough-fermented bread made from 100% wholegrain wheat flour milled by conventional roller milling (same wheat batch, starter, and fermentation protocol as the stone-milled bread). Consumed at breakfast and lunch, providing the same fixed dose of available carbohydrate as the stone-millled bread, for 3 consecutive days.",[66,73],[86],{"name":87,"affiliation":5,"role":88},"Simon N Dankel, PhD","PRINCIPAL_INVESTIGATOR",[90,94],{"name":87,"role":91,"phone":92,"phoneExt":49,"email":93},"CONTACT","+4794308637","simon.dankel@uib.no",{"name":95,"role":91,"phone":96,"phoneExt":49,"email":97},"Caroline Jensen, PhD","+4797078964","Caroline.J@uib.no",[99],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Research Unit for Health Surveys, University of Bergen","RECRUITING","Bergen","Vestland","5020","Norway","NO",{"type":108,"coordinates":109},"Point",[110,111],5.32415,60.39299,{"lat":111,"lon":110},[114,115,116,119,121],{"name":87,"role":91,"phone":92,"phoneExt":49,"email":93},{"name":87,"role":88,"phone":49,"phoneExt":49,"email":49},{"name":117,"role":118,"phone":49,"phoneExt":49,"email":49},"Live MA Vistnes, BSc","SUB_INVESTIGATOR",{"name":120,"role":118,"phone":49,"phoneExt":49,"email":49},"Kristina Solli, BSc",{"name":95,"role":118,"phone":49,"phoneExt":49,"email":49},{"type":123,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[125],{"name":126,"class":6},"Nofima","100658830","effects-of-wheat-flour-milling-method-on-glycemic-response-and-gastrointestinal-symptoms-100658830",false,"NCT07858110","Effects of Wheat Flour Milling Method on Glycemic Response and Gastrointestinal Symptoms","Effects of Wheat Flour Milling Method on Postprandial Glycemic Response and Gastrointestinal Symptoms: A Randomized Crossover Trial (STONEMILL)","STONEMILL","Inclusion Criteria:\n\n* BMI 18.5-25 kg\u002Fm2\n* Healthy, defined by reference to the exclusion criteria below\n* Habitual consumption of bread on most days, at more than one meal per day\n* Willing and able to consume the study breads, to follow the standardized meal pattern for 14 days, and to wear a CGM sensor continuously for 14 days\n\nExclusion Criteria:\n\n* Smoking\u002Ftobacco use\n* Any disease or condition or use of drugs or other compounds or treatments that could have a clinically significant impact on energy metabolism and\u002For gastrointestinal health (Roma IV to rule out IBS)\n* Diagnosed diabetes mellitus of any type (no screening measure of glycemic status will be obtained because sample collection is minimized within the project resources)\n* Diagnosed celiac disease, or self-reported gluten or wheat sensitivity leading to habitual avoidance of wheat products\n* Pregnancy or lactation\n* Systemic antibiotic use within 4 weeks before the calibration visit\n* Night-shift or rotating-shift work during the study period\n* Skin condition at the sensor site precluding CGM wear\n* No allergies to wheat\u002Fgrains",true,"ALL","20 Years","40 Years",{"count":140,"type":141},26,"ESTIMATED","INTERVENTIONAL",[144],"NA","The goal of this clinical trial is to learn if the way wheat flour is ground - by stone milling (an older method) or roller milling (used for most flour today) - changes blood sugar levels after eating bread, in healthy adults aged 20 to 40 who eat bread regularly. The main questions it aims to answer are:\n\nDoes bread made from stone-milled flour cause a smaller rise in blood sugar after breakfast than bread made from roller-milled flour? Does the milling method change stomach symptoms such as bloating?\n\nResearchers will compare bread made from stone-milled wheat flour to bread made from roller-milled wheat flour, made from the same wheat and prepared the same way, to see if milling method changes blood sugar and stomach symptoms.\n\nParticipants will:\n\nEat the study bread at breakfast and lunch for 3 days, then switch to the other bread for 3 days, in a random order Eat a standard bread for a few days before each 3-day period Wear a small sensor that tracks blood sugar day and night for 14 days Keep a daily food diary, including photos of meals Answer online questionnaires about stomach symptoms",[147,148],"Gastrointestinal Irritation","Nutrition, Healthy",[150],"Bread consumption, glucose regulation, glycemic index, gastrointestinal symptoms, bloating","2026-09-29",{"date":153,"type":154},"2026-10-05","ACTUAL",{"date":156,"type":141},"2026-10-14",{"date":158,"type":141},"2027-02-28",{"name":5,"class":6},1]