The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health

NCT06370936 | Recruiting

• 1 other identifier: NL84824.091.23
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Blood Pressure; Cardiometabolic Health

Keywords

Standardized diet; Plant based meat analogues; Blood pressure; Cardiometabolic health; Intestinal health; Microbiome; Animal meat

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  Systolic blood pressure as measured with in-clinic blood pressure measurements

  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

  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

  Twice daily for 16 weeks total (both 8-week interventions)

• Home diastolic blood pressure

  Twice daily for 16 weeks total (both 8-week interventions)

• Home heart rate

  Twice daily for 16 weeks total (both 8-week interventions)

• Fasting blood HbA1c levels

  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)

Other Outcomes (10)

• Body composition

  Baseline

• Genetic variation

  Baseline

• Oral glucose tolerance test (OGTT)

  Baseline

Study Arms (2)

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.

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.

Other: Standardized diet with commercially available animal meats (comparator products); Other: Standardized diet with commercially available PBMAs (intervention products)

Interventions

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.

Animal meats then PBMAs; PBMAs then Animal meats

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.

Animal meats then PBMAs; PBMAs then Animal meats

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI of 23-40 kg/m2
• Age 45-75 years
• Willing to consume both meat and PBMAs

You may not qualify if:

• 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)
• 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
• 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)

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6708 WE, Netherlands

RECRUITING

Study Officials

• Lydia Afman

  Wageningen University and Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roos van 't Spijker, MSc

CONTACT

+31 (0) 317 484 882; roos.vantspijker@wur.nl

Lydia Afman, dr. ir.

CONTACT

lydia.afman@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Treatment order (PBMA intervention - Meat intervention versus Meat intervention - PBMA intervention) is masked for the researchers. The order is not masked for participants.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: April 17, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)