Veranderingen in cardiometabole gezondheid en darmgezondheid Cardiovascular and metabolic health healthy bowel heart disease intestinal health
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - BMI of 23-40 kg/m2; - Age 45-75 years; - Willing to consume both meat and PBMAs; - Stable body weight (lost/gained ±
Exclusion criteria
Exclusion criteria: - Diseases or prior surgeries affecting the stomach, liver, kidneys or intestines (allowed i.e. appendectomy); - Food allergies, intolerances (including lactose/gluten intolerance) for products used in the study design and/or dietary restrictions interfering with the study (including special diets, vegetarians and eating disorders); - Cardiovascular diseases (e.g. heart failure. But hypertension up to 160 mmHg is allowed for inclusion as indicated by the research physician) or cancer (e.g. non-invasive skin cancer allowed); - Anaemia defined as Hb concentrations 160 mmHg*; - Major mental disorders; - Drug treated thyroid diseases (well substituted hypothyroidism is allowed for inclusion); - Diseases with a life expectation shorter than 5 years. - Regular use of/receiving medication interfering with research outcomes (as judged by research physician), such as use of glucose lowering drugs, insulin, use of medication that impacts gastric emptying, use of antipsychotics; - Starting or changing blood pressure medication type or dose during the study. (Continuation of blood pressure medication usage is allowed during study); - Use of anti-biotics over the last 3 months before study start. - Dietary habits interfering with study design (vegan/vegetarian, ketogenic diet etc.); - Intention to change the intensity of exercise during the study period; - Intention to lose weight during the study period; - Current smokers (including use of e-cigarettes); - Use of soft and/or hard drugs (cannabis included); - Abuse of alcohol (alcohol consumption defined as >14 glasses (women) or >21 glasses (men) of alcoholic beverages per week); - Use of strong vitamins or other dietary supplements (e.g. iron- or B12-supplements, pre- or probiotics) expected to interfere with the study outcomes. - Donated blood within 2 months prior to the screening; - Inability to comply with the study diet; - Being pregnant or lactating or planning to become pregnant; - Unable/unwilling to download a research application on the mobile phone; - Inability to understand study information and/or communicate with staff; - Inability/unwillingness to comply to staff instructions; - Displaying misbehaviour towards other participants/staff; - Participation in another study that involves an intervention within two months prior to the intervention; - Working or doing a thesis/internship at the division of Human Nutrition and Health or the Laboratory of Microbiology of Wageningen University. *Participants with a screening systolic blood pressure >145 mmHg - 140 mmHg (systolic) or >90 mmHg (diastolic) one or more times during the study, will receive a letter for referral to the general practitioner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the systolic blood pressure as measured with in-clinic blood pressure measurements after 8 weeks of intervention with PBMAs (corrected for baseline value) compared to 8 weeks of intervention with meat. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary objectives, we examine of the effect replacing all meat products in an average Dutch diet with currently commercially available PBMAs in a 2x8week crossover study on 1) cardiometabolic health, 2) gastro-intestinal microbiome and intestinal health, 3) well-being and 4) underlying biological mechanisms related to health. The specific outcomes related in the listing below. In addition, we aim to study the relation between diet specific responses (comparing PBMAs and meat products) and phenotype, including glucose responses and body composition. - Diastolic blood pressure as measured in-clinic - Diastolic & systolic blood pressure and heart rate as measured at-home - Blood glucose levels - Blood lipid spectrum -Fasting blood nutritional status including vitamin/mineral status - Blood immune and immune metabolism markers and immune cell populations - Circulating metabolites before and after a high fat mixed meal (HFMM) under fasting and postprandial (HFMM) conditions - Faecal microbiota composition - Oral microbiota composition - Microbial metabolites - Microbiome functionality - Gastro-intestinal symptoms - Gastro-intestinal transit time - Product-specific attitude towards and meal-specific satiety with meat and PBMAs; - General attitude towards meat and PBMAs. - Metabolomics in blood and 24-hour urine - Blood transcriptomics and proteomics | — |
Countries
Netherlands