Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370936
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-01-19
Brief Title:
The EXPLAIN Study Exploring Plant-Based Meat Analogues for Their Impact on Health
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
The EXPLAIN Study Exploring Plant-Based Meat Analogues for Their Impact on Health
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPLAIN
Brief 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 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 kgm2 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
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 kgm2 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 kgm2 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 PBMAsmeat 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
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 kgm2 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 PBMAsmeat 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8482409123 | OTHER | CCMO Toetsingonline | None |