protocolSection identificationModule nctId: NCT06370936, orgStudyIdInfo id: NL84824.091.23, secondaryIdInfos id: NL84824.091.23, type: OTHER, domain: CCMO / Toetsingonline, briefTitle: The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health, acronym: EXPLAIN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Wageningen University, class: OTHER, descriptionModule briefSummary: Plant-based diets with little to no meat are considered healthy and sustainable by the general public. The increasingly popular plant-based meat analogues (PBMAs) allow consumers to easily decrease meat intake while maintaining their dietary patterns. However, scientific knowledge on the health impact of PBMAs on humans is currently very limited.The primary objective of this clinical trial is to evaluate if and to what extent replacing all meat products in an average Dutch diet with currently commercially available PBMAs affects the systolic blood pressure of middle-aged men and women in a 2x8 week fully dietary controlled crossover intervention study. The secondary objectives are to assess the effect of this replacement of meat products with PBMAs on cardiometabolic health, gut microbiome, intestinal health, well-being, and underlying biological mechanisms.114 men and women with a BMI of 23-40 kg/m2, aged 45-75 years will be included in the study. Participants will follow both an 8-week completely controlled diet in which all meats are of plant-based origin (PBMAs) and an 8-week diet in which all meats are of animal origin in randomized order with a 10-week wash-out period. Before the intervention starts, the participants will be characterized to describe them on anthropometrics, glucose tolerance and insulin sensitivity, genetics, sleep patterns, and stress levels. Before the start and at the end of each 8-week dietary intervention period, several measurements, including systolic blood pressure monitoring and secondary outcome measures will be done. Additionally, systolic and diastolic blood pressure will be monitored throughout the dietary interventions and a small quantity of parameters related to the secondary objectives will be measured., conditionsModule conditions: Blood Pressure, conditions: Cardiometabolic Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will follow both an 8-week completely controlled dietary intervention followed by a 10-week washout period followed by another 8-week completely controlled dietary intervention., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Treatment order (PBMA intervention - Meat intervention versus Meat intervention - PBMA intervention) is masked for the researchers. The order is not masked for participants., whoMasked: INVESTIGATOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Standardized diet with commercially available animal meats (comparator products), interventions name: Standardized diet with commercially available PBMAs (intervention products), outcomesModule primaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Home systolic blood pressure, secondaryOutcomes measure: Home diastolic blood pressure, secondaryOutcomes measure: Home heart rate, secondaryOutcomes measure: Fasting blood HbA1c levels, secondaryOutcomes measure: Fasting blood glucose levels, secondaryOutcomes measure: Fasting blood insulin levels, secondaryOutcomes measure: Fasting blood lipid spectrum, secondaryOutcomes measure: Fasting blood metabolite profile, secondaryOutcomes measure: Fasting blood proteomic profile, secondaryOutcomes measure: Fasting blood cell transcriptomic profile, secondaryOutcomes measure: Fasting blood nutritional status, secondaryOutcomes measure: Blood immune markers, secondaryOutcomes measure: Blood immune cell populations, secondaryOutcomes measure: Metabolites in 24-hour urine, secondaryOutcomes measure: Interstitial glucose profile, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Fecal microbiome composition, secondaryOutcomes measure: Fasting and postprandial circulating metabolites with a high fat mixed meal (HFMM) challenge, secondaryOutcomes measure: Oral microbiome composition, secondaryOutcomes measure: Microbiome metabolites, secondaryOutcomes measure: Microbiome functionality, secondaryOutcomes measure: Self-reported gastro-intestinal symptoms, secondaryOutcomes measure: Self-reported constipation, secondaryOutcomes measure: Self-reported stool consistency and frequency, secondaryOutcomes measure: Gastro-intestinal transit time, secondaryOutcomes measure: Self reported product-specific attitude towards meat and PBMAs, secondaryOutcomes measure: Self reported meal-specific satiety with meat and PBMAs, secondaryOutcomes measure: Self-reported general attitude toward meat and PBMAs, otherOutcomes measure: Body composition, otherOutcomes measure: Genetic variation, otherOutcomes measure: Oral glucose tolerance test (OGTT), otherOutcomes measure: Habitual dietary intake, otherOutcomes measure: Perceived stress, otherOutcomes measure: Chronotype assessment, otherOutcomes measure: Sleeping habits, otherOutcomes measure: Self reported habitual meat and PBMA consumption, otherOutcomes measure: 24-hour dietary recall, otherOutcomes measure: Home environment microbiome composition, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wageningen University, Division of Human Nutrition, status: RECRUITING, city: Wageningen, state: Gelderland, zip: 6708 WE, country: Netherlands, geoPoint lat: 51.97, lon: 5.66667, hasResults: False