Exploring the health impact of plant-based meat alternatives on blood pressure
The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health
This study is testing if switching from regular meat to plant-based meat alternatives can help middle-aged men and women lower their blood pressure and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Wageningen University Academic / other |
| Locations | 1 site (Wageningen, Gelderland) |
| Trial ID | NCT06370936 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of replacing all meat products in a typical Dutch diet with commercially available plant-based meat analogues (PBMAs) on the systolic blood pressure of middle-aged men and women. Participants will undergo a fully controlled dietary intervention in a crossover design, consuming both a standardized diet with animal meats and one with PBMAs over two 8-week periods. The study also aims to assess the impact of PBMAs on cardiometabolic health, gut microbiome, intestinal health, and overall well-being. The findings could provide valuable insights into the health implications of adopting plant-based diets.
Who should consider this trial
Good fit: Ideal candidates are middle-aged men and women aged 45-75 years with a BMI between 23-40 kg/m2.
Not a fit: Patients with significant cardiovascular diseases, diabetes, or major mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help patients understand the potential health benefits of incorporating plant-based meat alternatives into their diets.
How similar studies have performed: While there is limited scientific knowledge on the health impact of PBMAs, similar dietary interventions have shown promise in improving health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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. \[\*Participants with a screening systolic blood pressure \>140 mmHg - ≤160 mmHg need written permission for participation without having (medical) treatment for the study period granted by their general practitioner after assessment of their cardiovascular risk. Participants within this screening range who cannot hand over written clearance from their general practitioner will be excluded from participation. Participants whose blood pressure has measured \>140 mmHg (systolic) or \>90 mmHg (diastolic) one or more times during the study, will receive a letter for referral to the general practitioner.\]
Where this trial is running
Wageningen, Gelderland
- Wageningen University, Division of Human Nutrition — Wageningen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Lydia Afman — Wageningen University and Research
- Study coordinator: Roos van 't Spijker, MSc
- Email: roos.vantspijker@wur.nl
- Phone: +31 (0) 317 484 882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.