Blood PressureEXPLAINNCT06370936
The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health
A study testing Standardized diet with commercially available animal meats (comparator products) and Standardized diet with commercially available PBMAs (intervention products) in people with Blood Pressure and Cardiometabolic Health, run by Wageningen University at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Cardiometabolic Health
- What is being tested?
- Standardized diet with commercially available animal meats (comparator products) and Standardized diet with commercially available PBMAs (intervention products)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 23-40 kg/m2
- Age 45-75 years
- Willing to consume both meat and PBMAs
- Stable body weight (lost/gained ± <3 kg over the last 3 months prior to inclusion)
Who cannot join
- 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)
- Anemia defined as Hb concentrations <8.5 mmol/L for men and <7.5 mmol/L for women
- Diagnosed with type 1 or type 2 diabetes
- Blood pressure >160 mmHg*
Show all 29Show fewer
- 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 the 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 the study)
- Use of anti-biotics over the last 3 months before the 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 with staff instructions
- Displaying misbehavior 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 >140 mmHg - ≤160 mmHg need written permission for participation without having (medical) treatment for the study period granted by their general practitioner after assessment of their cardiovascular risk. Participants within this screening range who cannot hand over written clearance from their general practitioner will be excluded from participation. Participants whose blood pressure has measured >140 mmHg (systolic) or >90 mmHg (diastolic) one or more times during the study, will receive a letter for referral to the general practitioner.]
Trial locations and contacts
1 site in 1 country.
Lydia Afman, dr. ir. contact
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, 6708 WE
About this study
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.
Read the detailed description
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.
- Conditions
- Blood Pressure, Cardiometabolic Health
- Being tested
- Standardized diet with commercially available animal meats (comparator products), Standardized diet with commercially available PBMAs (intervention products)
- Keywords
- Standardized diet, Plant based meat analogues, Blood pressure, Cardiometabolic health, Intestinal health, Microbiome, Animal meat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized diet with commercially available animal meats (comparator products)Other
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.
Standardized diet with commercially available PBMAs (intervention products)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Animal meats then PBMAs | Experimental | For the first treatment period of 8 weeks, participants receive a standardized diet with a variety of meat products, after a 10-week washout period this is followed by a standardized diet with a variety of PBMAs for the second treatment period. Receives: Other: Standardized diet with commercially available animal meats (comparator products); Other: Standardized diet with commercially available PBMAs (intervention products) |
| PBMAs then Animal meats | Experimental | For the first treatment period of 8 weeks, participants receive a standardized diet with a variety of PBMAs, after a 10-week washout period this is followed by a standardized diet with a variety of meat products for the second treatment period. Receives: Other: Standardized diet with commercially available animal meats (comparator products); Other: Standardized diet with commercially available PBMAs (intervention products) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure as measured with in-clinic blood pressure measurements
Measured: 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)
Secondary outcomes (29)
Diastolic blood pressure
Diastolic blood pressure as measured with in-clinic blood pressure measurements
Measured: 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
Measured: Twice daily for 16 weeks total (both 8-week interventions)
Home diastolic blood pressure
Diastolic blood pressure as measured by participant at-home
Measured: 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
Measured: Twice daily for 16 weeks total (both 8-week interventions)
Fasting blood HbA1c levels
Fasting HbA1c concentration
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 4 weeks during trial, 2 continuous weeks per 8-week intervention
Fecal microbiome composition
Microbiome composition in the feces.
Measured: 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.
Measured: 2 times during the trial. 1 time at the end of each 8 week-intervention.
Oral microbiome composition
Microbiome composition in saliva.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 10 times during trial. 5 times per 8-week intervention (before intervention, week 1,2,4 and 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia A. Afman, Wageningen University
- Investigators
- Lydia Afman, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370936
- Sponsor's protocol ID
- NL84824.091.23
- Other IDs
- NL84824.091.23
- Acronym
- EXPLAIN
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health
- ClinicalTrials.gov ID
- NCT06370936
- Acronym / sponsor ID
- EXPLAIN / NL84824.091.23
- Conditions
- Blood Pressure, Cardiometabolic Health
- Keywords
- Standardized diet, Plant based meat analogues, Blood pressure, Cardiometabolic health, Intestinal health, Microbiome, Animal meat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Animal meats then PBMAs | Experimental | Other: Standardized diet with commercially available animal meats (comparator products), Other: Standardized diet with commercially available PBMAs (intervention products)For the first treatment period of 8 weeks, participants receive a standardized diet with a variety of meat products, after a 10-week washout period this is followed by a standardized diet with a variety of PBMAs for the second treatment period. |
| PBMAs then Animal meats | Experimental | Other: Standardized diet with commercially available animal meats (comparator products), Other: Standardized diet with commercially available PBMAs (intervention products)For the first treatment period of 8 weeks, participants receive a standardized diet with a variety of PBMAs, after a 10-week washout period this is followed by a standardized diet with a variety of meat products for the second treatment period. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI of 23-40 kg/m2
- Age 45-75 years
- Willing to consume both meat and PBMAs
- Stable body weight (lost/gained ± <3 kg over the last 3 months prior to inclusion)
Key exclusion criteria (29 listed)
- 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)
- Anemia defined as Hb concentrations <8.5 mmol/L for men and <7.5 mmol/L for women
- Diagnosed with type 1 or type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized diet with commercially available animal meats (comparator products)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. | Other | Animal meats then PBMAs, PBMAs then Animal meats |
| Standardized diet with commercially available PBMAs (intervention products)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. | Other | Animal meats then PBMAs, PBMAs then Animal meats |
Primary outcome
Systolic blood pressure
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)
Systolic blood pressure as measured with in-clinic blood pressure measurements
29 secondary outcomes
Diastolic blood pressure
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
Time frame: Twice daily for 16 weeks total (both 8-week interventions)
Home diastolic blood pressure
Time frame: Twice daily for 16 weeks total (both 8-week interventions)
Home heart rate
Time frame: Twice daily for 16 weeks total (both 8-week interventions)
Fasting blood HbA1c levels
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
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
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
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
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
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
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
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
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
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
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
Time frame: 4 weeks during trial, 2 continuous weeks per 8-week intervention
Physical activity
Time frame: 4 weeks during trial, 2 continuous weeks per 8-week intervention
Fecal microbiome composition
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
Time frame: 2 times during the trial. 1 time at the end of each 8 week-intervention.
Oral microbiome composition
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
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Microbiome functionality
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
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Self-reported constipation
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
Time frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
Gastro-intestinal transit time
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
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
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
Time frame: 10 times during trial. 5 times per 8-week intervention (before intervention, week 1,2,4 and 8).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia Afman, dr. ir. contact
Lydia Afman principal investigator
Wageningen University and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized diet with commercially available animal meats (comparator products) and Standardized diet with commercially available PBMAs (intervention products) in people with Blood Pressure and Cardiometabolic Health, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roos van 't Spijker, MSc (+31 (0) 317 484 882, roos.vantspijker@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.