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.
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. PBMAs are designed to mimic the sensory and textural properties of meat and to replace animal protein with plant protein. Processing of plant-based ingredients is needed to achieve this, which potentially compromises the sustainability and health assets of PBMAs. One of the concerns with processing is that it results in relatively high salt levels in the products, which could affect the blood pressure of consumers. However, scientific knowledge on the health impact of PBMAs on humans is currently very limited. Therefore, a fully controlled dietary intervention with a standardized diet is needed to evaluate the health impact of commercially available PBMAs. The primary objective 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, and intestinal health, well-being, and underlying biological mechanisms. In addition, the investigators aim to study the relation between diet-specific responses (comparing PBMAs and meat products) and phenotype, including glucose responses and body composition. The study compromises a randomized crossover fully controlled dietary intervention at Wageningen University which consists of 2x8 week interventions separated by a 10-week washout 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. The study population consists of 114 men and women with a BMI of 23-40 kg/m2, aged 45-75 years, and weight stable (± \<3kg) for at least three months before inclusion. 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. Diets are fully controlled which implies that all foods and meals are provided to participants by the Human Nutrition Research Unit (HNRU) and are based on participants' habitual energy needs to maintain a stable body weight throughout the study. Except for PBMAs/meat, all other foods will be identical in both intervention diets. The composition of the diets is based on the Dutch National Food Consumption Survey. All food products provided, including the PBMAs, are commercially available. The total study duration for a participant will be a little over \>6 months, including the 10-week washout. The total time that needs to be invested by participants in this study with visits and at-home measurements is 72 hours. Participants are restricted for a total of 16 weeks in their eating habits since they need to follow a fully standardized diet. Subjects will have their blood pressure measured at the HNRU and additionally will have to measure their blood pressure at home. In addition, subjects have to wear continuous glucose and physical activity monitors twice during the study for a total of approximately 28 days. During the characterization period, participants will visit the HNRU once or twice depending on participant preference. For the measurements before and at the end of each dietary intervention period, participants visit the HNRU three times per intervention period (one extra visit after for the HFMM), so six times total. Additionally, during the dietary intervention, participants will visit the Human Research Unit twice a week during dinner time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
114
Fully controlled standardized diet with commercially available meats from animal origin. Fully controlled means that all food products 8-week intervention will be provided by the HNRU at Wageningen University. The standardized diet is designed to maintain body weight, and follows the average nutritional pattern of middle-aged men and women in the Netherlands, while taking individual habitual energy intake into account. The diet will have the same dietary composition for each person and energy intake will be based on the energy requirements of an individual. The diet is the same for both intervention periods, except for the origin of meat products: PBMAs versus meat of animal origin.
Fully controlled standardized diet with commercially available Plant-Based Meat Analogues (PBMAs). Fully controlled means that all food products 8-week intervention will be provided by the HNRU at Wageningen University. The standardized diet is designed to maintain body weight, and follows the average nutritional pattern of middle-aged men and women in the Netherlands, while taking individual habitual energy intake into account. The diet will have the same dietary composition for each person and energy intake will be based on the energy requirements of an individual. The diet is the same for both intervention periods, except for the origin of meat products: PBMAs versus meat of animal origin.
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, Netherlands
RECRUITINGSystolic blood pressure
Systolic blood pressure as measured with in-clinic blood pressure measurements
Time frame: 12 times during the trial, 6 times per 8-week intervention (1 time before intervention period, then biweekly measurements, and 1 measurements in week 8 of 8-week intervention)
Diastolic blood pressure
Diastolic blood pressure as measured with in-clinic blood pressure measurements
Time frame: 12 times during the trial, 6 times per 8-week intervention (1 time before intervention period, then biweekly measurements, and 1 measurements in week 8 of 8-week intervention)
Home systolic blood pressure
Systolic blood pressure as measured by participant at-home
Time frame: Twice daily for 16 weeks total (both 8-week interventions)
Home diastolic blood pressure
Diastolic blood pressure as measured by participant at-home
Time frame: Twice daily for 16 weeks total (both 8-week interventions)
Home heart rate
Heart rate as measured by participant at-home with blood pressure monitor
Time frame: Twice daily for 16 weeks total (both 8-week interventions)
Fasting blood HbA1c levels
Fasting HbA1c concentration
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Fasting blood glucose levels
Fasting glucose concentration
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Fasting blood insulin levels
Fasting insulin concentration
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Fasting blood lipid spectrum
Metabolomic analysis to determine all circulating blood lipids, including all cholesterol types, triglycerides and free fatty acids
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Fasting blood metabolite profile
Fasting blood metabolome as determined by metabolomics.
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Fasting blood proteomic profile
Proteomic analysis of fasting blood, incorporating an O-link panel, to determine circulating blood proteins, including protein biomarkers for inflammation such as cytokines.
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Fasting blood cell transcriptomic profile
Analysis of blood cells using transcriptomics to determine the blood transcriptome.
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Fasting blood nutritional status
Circulating vitamins and minerals related to meat and plant-based meat intake, including important circulating vitamins such as vitamins B6, B12, and D, and minerals such as markers of iron status, zinc, magnesium, and calcium.
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Blood immune markers
Blood immune- and immune-metabolism markers. This includes immune-related proteins including cytokines.
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Blood immune cell populations
Blood (immune) cell subpopulations. This compromises of whole blood CD45+ cell subset abundance such as abundance of T-lymphocytes and B-lymphocytes.
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Metabolites in 24-hour urine
Metabolomic analysis of urine collected over 24 hours, including markers for sodium excretion, urea nitrogen excretion, kidney function and consumption of (plant-based) meat, pH, and volume of urine.
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Interstitial glucose profile
Interstitial glucose concentrations, as measured by continuous glucose monitoring.
Time frame: 4 weeks during trial, 2 continuous weeks per 8-week intervention
Physical activity
Continuous physical activity levels, measured by the Actigraph accelerometer wGT3X-BT (ActiGraph, Pensacola, USA)
Time frame: 4 weeks during trial, 2 continuous weeks per 8-week intervention
Fecal microbiome composition
Microbiome composition in the feces.
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Fasting and postprandial circulating metabolites with a high fat mixed meal (HFMM) challenge
Circulating fasting and postprandial metabolites upon a high-fat mixed meal (HFMM). At t=0, 30, 60, 90, 120, 180, and 240 minutes after the consumption of the HFMM blood is collected. This measurement is only for participants with veins suitable for a Venflon catheter.
Time frame: 2 times during the trial. 1 time at the end of each 8 week-intervention.
Oral microbiome composition
Microbiome composition in saliva.
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Microbiome metabolites
Microbial metabolites of interest, such as SCFAs will be measured using high-performance liquid chromatography (HPLC).
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Microbiome functionality
Microbiome functionality and genetic composition is assessed using batch-fermentation.
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Self-reported gastro-intestinal symptoms
Gastro-intestinal symptoms as measured using the GSRS questionnaire (gastro-intestinal rating scale). The GSRS contains five scales: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. Scores between 1-7. Low scores indicated absence or mild presence of symptoms, high scores indicated heavy presence of symptoms.
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Self-reported constipation
Gastro-intestinal obstipation symptoms as measured using the PAC-SYM questionnaire (Patient Assessment of Constipation Symptoms). Scores between 1-4. Low scores indicated absence or mild presence of symptoms, high scores indicated heavy presence of symptoms.
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Self-reported stool consistency and frequency
Self-reported stool consistency and frequency by using the Bristol Stool Chart (BSC) (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Gastro-intestinal transit time
Transit time measured using the blue dye method
Time frame: 4 times during the trial. 2 times per 8 week-intervention (1 time before intervention and 1 time during week 8 of 8-week intervention)
Self reported product-specific attitude towards meat and PBMAs
Self-reported product-specific attitude towards meat and PBMAs as measured using a questionnaire. Scores between 1-7. Low scores indicate a negative attitude toward the product, and high scores indicate a positive attitude toward the product.
Time frame: 6 times during trial. 3 times per 8-week intervention, during CGM (continuous glucose monitor) wearing period.
Self reported meal-specific satiety with meat and PBMAs
Self reported meal-specific satiety with meat and PBMAs measured using a questionnaire. The Visual Analogue Scale (VAS) is used for questions about satiety and Likert scale is used to assess the intensity of product attributes. Low scores indicate low liking/experience, and high scores indicate high liking/experience.
Time frame: 6 times during trial. 3 times per 8-week intervention, during CGM (continuous glucose monitor) wearing period.
Self-reported general attitude toward meat and PBMAs
Self-reported general attitude toward meat and PBMAs as measured using a questionnaire. Scores between 1-7. Low scores indicate a negative general attitude and high scores indicate a positive general attitude
Time frame: 10 times during trial. 5 times per 8-week intervention (before intervention, week 1,2,4 and 8).
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