- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06370936
The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health (EXPLAIN)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roos van 't Spijker, MSc
- Phone Number: +31 (0) 317 484 882
- Email: roos.vantspijker@wur.nl
Study Contact Backup
- Name: Lydia Afman, dr. ir.
- Email: lydia.afman@wur.nl
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6708 WE
- Recruiting
- Wageningen University, Division of Human Nutrition
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
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)
- 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*
- 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.]
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Animal meats then PBMAs
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.
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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.
|
Experimental: PBMAs then Animal meats
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Systolic blood pressure as measured with in-clinic blood pressure measurements
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Diastolic blood pressure as measured with in-clinic blood pressure measurements
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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)
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Home systolic blood pressure
Time Frame: Twice daily for 16 weeks total (both 8-week interventions)
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Systolic blood pressure as measured by participant at-home
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Twice daily for 16 weeks total (both 8-week interventions)
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Home diastolic blood pressure
Time Frame: Twice daily for 16 weeks total (both 8-week interventions)
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Diastolic blood pressure as measured by participant at-home
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Twice daily for 16 weeks total (both 8-week interventions)
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Home heart rate
Time Frame: Twice daily for 16 weeks total (both 8-week interventions)
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Heart rate as measured by participant at-home with blood pressure monitor
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Twice daily for 16 weeks total (both 8-week interventions)
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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)
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Fasting HbA1c concentration
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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)
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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)
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Fasting glucose concentration
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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)
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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)
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Fasting insulin concentration
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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)
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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)
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Metabolomic analysis to determine all circulating blood lipids, including all cholesterol types, triglycerides and free fatty acids
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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)
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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)
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Fasting blood metabolome as determined by metabolomics.
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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)
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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)
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Proteomic analysis of fasting blood, incorporating an O-link panel, to determine circulating blood proteins, including protein biomarkers for inflammation such as cytokines.
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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)
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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)
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Analysis of blood cells using transcriptomics to determine the blood transcriptome.
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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)
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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)
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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.
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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)
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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)
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Blood immune- and immune-metabolism markers.
This includes immune-related proteins including cytokines.
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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)
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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)
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Blood (immune) cell subpopulations.
This compromises of whole blood CD45+ cell subset abundance such as abundance of T-lymphocytes and B-lymphocytes.
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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)
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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)
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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.
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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)
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Interstitial glucose profile
Time Frame: 4 weeks during trial, 2 continuous weeks per 8-week intervention
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Interstitial glucose concentrations, as measured by continuous glucose monitoring.
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4 weeks during trial, 2 continuous weeks per 8-week intervention
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Physical activity
Time Frame: 4 weeks during trial, 2 continuous weeks per 8-week intervention
|
Continuous physical activity levels, measured by the Actigraph accelerometer wGT3X-BT (ActiGraph, Pensacola, USA)
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4 weeks during trial, 2 continuous weeks per 8-week intervention
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Fecal microbiome composition
Time Frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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Microbiome composition in the feces.
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18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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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.
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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.
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2 times during the trial. 1 time at the end of each 8 week-intervention.
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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)
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Microbiome composition in saliva.
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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)
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Microbiome metabolites
Time Frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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Microbial metabolites of interest, such as SCFAs will be measured using high-performance liquid chromatography (HPLC).
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18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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Microbiome functionality
Time Frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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Microbiome functionality and genetic composition is assessed using batch-fermentation.
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18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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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.
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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.
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18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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Self-reported constipation
Time Frame: 18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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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.
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18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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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.
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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.
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18 times during trial. Done 1 time before each 8-week intervention and weekly during 8-week intervention.
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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)
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Transit time measured using the blue dye method
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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)
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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.
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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.
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6 times during trial. 3 times per 8-week intervention, during CGM (continuous glucose monitor) wearing period.
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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.
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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.
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6 times during trial. 3 times per 8-week intervention, during CGM (continuous glucose monitor) wearing period.
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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).
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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
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10 times during trial. 5 times per 8-week intervention (before intervention, week 1,2,4 and 8).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: Baseline
|
Body composition as measured by DEXA (Dual Energy X-ray Absorptiometry).
|
Baseline
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Genetic variation
Time Frame: Baseline
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Single Nucleotide Polymorphisms (SNPs) in genes relevant for metabolism and responses to food, collected using a mouth swab and/or buffycoat.
|
Baseline
|
Oral glucose tolerance test (OGTT)
Time Frame: Baseline
|
A 6-point OGTT measuring fasting and postprandial glucose and insulin responses.
At t=0, 15, 30, 45, 60, 90, and 120 minutes, blood will be collected to measure plasma glucose and insulin concentrations.
At t=0, HbA1c concentrations will also be determined.
This measurement is only for participants with veins suitable for a Venflon catheter.
|
Baseline
|
Habitual dietary intake
Time Frame: Baseline
|
Habitual dietary intake assessment with a food frequency questionnaire (FFQ).
|
Baseline
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Perceived stress
Time Frame: Baseline
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Perceived stress of participant over past month as measured with the Perceived Stress Scale (PSS-10)
|
Baseline
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Chronotype assessment
Time Frame: Baseline
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Chronotype assessment of participant with reduced Morning-Eveningness Questionnaire (rMEQ)
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Baseline
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Sleeping habits
Time Frame: Baseline
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Sleeping habits of participants over the past month as measured using the Pittsburgh Sleep Quality Index (PSQI).
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Baseline
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Self reported habitual meat and PBMA consumption
Time Frame: 3 times during trial. At baseline and 2 times during 10-week washout period.
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Habitual dietary meat and PBMA consumption assessment using a questionnaire.
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3 times during trial. At baseline and 2 times during 10-week washout period.
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24-hour dietary recall
Time Frame: 6 times during the 10-week washout period
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24-hour dietary recall done using the Traqq mobile phone application.
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6 times during the 10-week washout period
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Home environment 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)
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Microbiome composition on electrostatic dust collectors (EDC) that are placed in participants home for 2 consecutive weeks accompanied with regarding geographic location and placement of EDC.
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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)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lydia Afman, Wageningen University and Research
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL84824.091.23 (Other Identifier: CCMO / Toetsingonline)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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