The EXPLAIN Study: Exploring plant-based meat analogues for their Impact on health

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 114

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);
- Anaemia 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 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 study);
- Use of anti-biotics over the last 3 months before 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 to staff instructions;
- Displaying misbehaviour 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 >145 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 that cannot
handover written clearance of 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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the systolic blood pressure as measured with<br /><br>in-clinic blood pressure measurements after 8 weeks of intervention with PBMAs<br /><br>(corrected for baseline value) compared to 8 weeks of intervention with meat.</p><br>

Secondary Outcome Measures